Trial Outcomes & Findings for Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO) (NCT NCT06091215)
NCT ID: NCT06091215
Last Updated: 2026-01-27
Results Overview
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
COMPLETED
NA
15 participants
Baseline, 1 Month
2026-01-27
Participant Flow
Participant milestones
| Measure |
Healthy Participants- Single Treatment Group
Subjects will receive 1 BBL/MOXI/HALO treatments. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment.
Sciton Joule System: Sciton Joule System
|
Healthy Participants- Double Treatment Group
Subjects will receive 2 BBL/MOXI/HALO treatments. All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to ensure the skin has enough time to recover. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment.
|
|---|---|---|
|
Single treatment (4 weeks)
STARTED
|
7
|
8
|
|
Single treatment (4 weeks)
COMPLETED
|
7
|
8
|
|
Single treatment (4 weeks)
NOT COMPLETED
|
0
|
0
|
|
Double treatment (8 weeks)
STARTED
|
0
|
8
|
|
Double treatment (8 weeks)
COMPLETED
|
0
|
8
|
|
Double treatment (8 weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)
Baseline characteristics by cohort
| Measure |
Single Treatment Arm
n=7 Participants
Subjects will receive a single treatment of BBL/MOXI/HALO
Sciton Joule System: Sciton Joule System
|
Double Treatment Arm
n=8 Participants
Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart.
Sciton Joule System: Sciton Joule System
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=41 Participants
|
8 participants
n=1581 Participants
|
15 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
Front
|
12.00 count of spots
Interval -2.0 to 17.0
|
|
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
5.00 count of spots
Interval -11.0 to 7.0
|
|
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
Nose
|
0.00 count of spots
Interval -3.0 to 1.0
|
|
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
5.00 count of spots
Interval -11.0 to 5.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
Front
|
8.00 count of spots
Interval 6.0 to 12.0
|
|
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
.00 count of spots
Interval -2.0 to 25.0
|
|
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
Nose
|
3.00 count of spots
Interval -1.0 to 5.0
|
|
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
9.00 count of spots
Interval -2.0 to 25.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
Front
|
-2.00 count of spots
Interval -14.0 to 0.5
|
|
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
-3.50 count of spots
Interval -9.0 to -0.5
|
|
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
Nose
|
-2.00 count of spots
Interval -4.5 to -0.5
|
|
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-2.50 count of spots
Interval -16.5 to 12.5
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
Front
|
-0.50 count of spots
Interval -12.0 to 9.0
|
|
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
-4.00 count of spots
Interval -9.5 to 6.5
|
|
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
Nose
|
-0.50 count of spots
Interval -3.5 to 1.5
|
|
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
8.50 count of spots
Interval -14.0 to 22.5
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Pores at 1 Month From Baseline (Single Treatment Group)
Front
|
-5.00 count of pores
Interval -11.0 to 10.0
|
|
Change in Pores at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-5.00 count of pores
Interval -13.0 to 17.0
|
|
Change in Pores at 1 Month From Baseline (Single Treatment Group)
Nose
|
-11.00 count of pores
Interval -21.0 to 3.0
|
|
Change in Pores at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
-3.00 count of pores
Interval -7.0 to 10.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Pores at 3 Months From Baseline (Single Treatment Group)
Front
|
1.00 count of pores
Interval -34.0 to 14.0
|
|
Change in Pores at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
-1.00 count of pores
Interval -6.0 to 17.0
|
|
Change in Pores at 3 Months From Baseline (Single Treatment Group)
Nose
|
1.00 count of pores
Interval -15.0 to 5.0
|
|
Change in Pores at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
-7.00 count of pores
Interval -21.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Pores at 1 Month From Baseline (Double Treatment Group)
Front
|
2.50 count of pores
Interval -41.0 to 23.5
|
|
Change in Pores at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
-27.50 count of pores
Interval -72.0 to 10.0
|
|
Change in Pores at 1 Month From Baseline (Double Treatment Group)
Nose
|
-10.00 count of pores
Interval -28.0 to -5.5
|
|
Change in Pores at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-17.00 count of pores
Interval -60.0 to 34.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Pores at 3 Months From Baseline (Double Treatment Group)
Front
|
-0.00 count of pores
Interval 0.0 to 0.0
|
|
Change in Pores at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
-0.00 count of pores
Interval 0.0 to 0.0
|
|
Change in Pores at 3 Months From Baseline (Double Treatment Group)
Nose
|
-0.00 count of pores
Interval -0.01 to 0.0
|
|
Change in Pores at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
-0.00 count of pores
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
Front
|
17.00 count of porphyrins
Interval -292.0 to 217.0
|
|
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
51.00 count of porphyrins
Interval -381.0 to 331.0
|
|
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
Nose
|
15.00 count of porphyrins
Interval -49.0 to 66.0
|
|
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
4.00 count of porphyrins
Interval -290.0 to 351.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
Front
|
-123.00 count of porphyrins
Interval -365.0 to 272.0
|
|
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
-192.00 count of porphyrins
Interval -446.0 to 99.0
|
|
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
Nose
|
32.00 count of porphyrins
Interval -19.0 to 88.0
|
|
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
-114.00 count of porphyrins
Interval -420.0 to 136.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
Front
|
1.00 count of porphyrins
Interval -312.0 to 395.5
|
|
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
164.50 count of porphyrins
Interval -56.5 to 730.0
|
|
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
Nose
|
45.50 count of porphyrins
Interval -25.0 to 94.5
|
|
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
214.50 count of porphyrins
Interval -39.5 to 789.5
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
Front
|
-160.50 count of porphyrins
Interval -266.0 to -1.0
|
|
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
-145.50 count of porphyrins
Interval -263.0 to 158.5
|
|
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
Nose
|
3.00 count of porphyrins
Interval -66.0 to 60.0
|
|
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
13.00 count of porphyrins
Interval -278.5 to 135.5
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
Front
|
1.00 count of red features
Interval -1.0 to 5.0
|
|
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-7.00 count of red features
Interval -10.0 to 2.0
|
|
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
Nose
|
-1.00 count of red features
Interval -3.0 to 10.0
|
|
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
-2.00 count of red features
Interval -7.0 to 12.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
Front
|
2.00 count of red features
Interval -6.0 to 5.0
|
|
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
Nose
|
0.00 count of red features
Interval -4.0 to 3.0
|
|
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
0.00 count of red features
Interval -17.0 to 9.0
|
|
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
-7.00 count of red features
Interval -12.0 to 7.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
Front
|
4.00 count of red features
Interval 1.5 to 9.0
|
|
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
7.50 count of red features
Interval -1.5 to 11.0
|
|
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
Nose
|
0.00 count of red features
Interval -2.5 to 2.5
|
|
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
3.50 count of red features
Interval -14.0 to 8.5
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Frontal- 2 subjects data was incomplete. Left- 1 subject data was incomplete The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
Front
|
2.00 count of red features
Interval -0.5 to 9.5
|
|
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
5.50 count of red features
Interval 1.0 to 15.0
|
|
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
Nose
|
1.00 count of red features
Interval -2.0 to 3.0
|
|
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
2.50 count of red features
Interval -10.5 to 5.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Texture at 1 Month From Baseline (Single Treatment Group)
Front
|
-14.00 unitless
Interval -125.0 to 521.0
|
|
Change in Texture at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-3.00 unitless
Interval -336.0 to 354.0
|
|
Change in Texture at 1 Month From Baseline (Single Treatment Group)
Nose
|
-1.00 unitless
Interval -42.0 to 14.0
|
|
Change in Texture at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
68.00 unitless
Interval -99.0 to 453.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Texture at 3 Months From Baseline (Single Treatment Group)
Front
|
64.00 unitless
Interval -210.0 to 147.0
|
|
Change in Texture at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
188.00 unitless
Interval 45.0 to 302.0
|
|
Change in Texture at 3 Months From Baseline (Single Treatment Group)
Nose
|
30.00 unitless
Interval -30.0 to 302.0
|
|
Change in Texture at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
161.00 unitless
Interval 19.0 to 396.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Texture at 1 Month From Baseline (Double Treatment Group)
Front
|
20.50 unitless
Interval -216.0 to 413.0
|
|
Change in Texture at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
-198.00 unitless
Interval -569.0 to 155.0
|
|
Change in Texture at 1 Month From Baseline (Double Treatment Group)
Nose
|
4.00 unitless
Interval -19.0 to 41.5
|
|
Change in Texture at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-225.50 unitless
Interval -506.0 to -25.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Texture at 3 Months From Baseline (Double Treatment Group)
Front
|
-25.00 unitless
Interval -146.5 to 212.5
|
|
Change in Texture at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
82.00 unitless
Interval -141.0 to 236.0
|
|
Change in Texture at 3 Months From Baseline (Double Treatment Group)
Nose
|
16.50 unitless
Interval -2.5 to 43.0
|
|
Change in Texture at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
-72.00 unitless
Interval -246.0 to 171.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
Front
|
-4.00 count of UV spots
Interval -8.0 to -1.0
|
|
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-4.00 count of UV spots
Interval -11.0 to 3.0
|
|
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
Nose
|
0.00 count of UV spots
Interval -6.0 to 2.0
|
|
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
0.00 count of UV spots
Interval -1.0 to 11.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
Front
|
-3.00 count of UV spots
Interval -15.0 to 6.0
|
|
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
-4.00 count of UV spots
Interval -12.0 to 11.0
|
|
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
Nose
|
-2.00 count of UV spots
Interval -3.0 to 1.0
|
|
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
1.00 count of UV spots
Interval -4.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
Nose
|
-2.50 count of UV spots
Interval -5.5 to 1.0
|
|
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-1.00 count of UV spots
Interval -25.0 to 6.0
|
|
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
Front
|
-1.50 count of UV spots
Interval -11.5 to 7.5
|
|
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
5.00 count of UV spots
Interval -19.5 to 11.5
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
Front
|
-1.00 count of UV spots
Interval -15.0 to 4.5
|
|
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
-7.50 count of UV spots
Interval -15.5 to 13.5
|
|
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
Nose
|
-2.50 count of UV spots
Interval -4.0 to 1.0
|
|
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
4.50 count of UV spots
Interval -7.5 to 10.5
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
Frontal
|
2.00 count of visible spots
Interval 0.0 to 12.0
|
|
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-3.00 count of visible spots
Interval -6.0 to 4.0
|
|
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
Nose
|
-1.00 count of visible spots
Interval -1.0 to 0.0
|
|
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
3.00 count of visible spots
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
Frontal
|
6.00 count of visible spots
Interval 3.0 to 9.0
|
|
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
1.00 count of visible spots
Interval -3.0 to 4.0
|
|
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
Nose
|
0.00 count of visible spots
Interval -1.0 to 5.0
|
|
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
3.00 count of visible spots
Interval -4.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
Frontal
|
6.00 count of visible spots
Interval -12.5 to 20.5
|
|
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
-6.50 count of visible spots
Interval -11.5 to 6.5
|
|
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
Nose
|
-0.50 count of visible spots
Interval -2.5 to 0.5
|
|
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-11.00 count of visible spots
Interval -14.0 to 6.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
Frontal
|
-2.00 count of visible spots
Interval -5.0 to 4.0
|
|
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
0.00 count of visible spots
Interval -7.5 to 8.5
|
|
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
Nose
|
-0.50 count of visible spots
Interval -1.0 to 1.5
|
|
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
-0.50 count of visible spots
Interval -5.5 to 11.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
Front
|
-1.00 mm^2
Interval -3.0 to 0.0
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
Left Oblique
|
-13.00 mm^2
Interval -17.0 to -3.0
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
Nose
|
-3.00 mm^2
Interval -3.0 to 0.0
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
Right Oblique
|
5.00 mm^2
Interval -63.0 to 12.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
Front
|
-1.00 mm^2
Interval -2.0 to 3.0
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
Left Oblique
|
-1.00 mm^2
Interval -12.0 to 18.0
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
Nose
|
1.00 mm^2
Interval -5.0 to 1.0
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
Right Oblique
|
5.00 mm^2
Interval -24.0 to 24.0
|
PRIMARY outcome
Timeframe: Baseline, 1 MonthPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
Front
|
0.50 mm^2
Interval -3.0 to 1.0
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
Left Oblique
|
-14.50 mm^2
Interval -42.0 to 0.5
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
Nose
|
-2.50 mm^2
Interval -5.5 to -0.5
|
|
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
Right Oblique
|
-14.50 mm^2
Interval -39.5 to -2.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Analysis was focused on testing whether the effect of the treatment on each parameter differed Nose- 1 subject didn't have complete data thus it was not included in analysis The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
Quantitively assessment of porphyrins count using measurements provided from VISIA 3D analysis
A lower value signifies improvement
|
|---|---|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
Left Oblique
|
12.00 mm^2
Interval -16.0 to 21.5
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
Nose
|
-1.00 mm^2
Interval -4.5 to 2.5
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
Front
|
0.00 mm^2
Interval -2.0 to 0.0
|
|
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
Right Oblique
|
-13.50 mm^2
Interval -31.5 to 6.0
|
Adverse Events
Single Treatment Group Participants
Double Treatment Group Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place