Trial Outcomes & Findings for Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes. (NCT NCT05226104)
NCT ID: NCT05226104
Last Updated: 2023-08-21
Results Overview
Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
COMPLETED
NA
30 participants
Baseline, Month 1 and Month 3
2023-08-21
Participant Flow
27 patients underwent two treatments with non-ablative, f1927nm laser.
Participant milestones
| Measure |
Non-ablative f1927nm Laser
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|
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Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.
Baseline characteristics by cohort
| Measure |
Non-ablative f1927nm Laser
n=27 Participants
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Fitzpatrick Skin Prototype
Type 1
|
4 Participants
n=99 Participants
|
|
Fitzpatrick Skin Prototype
Type 2
|
7 Participants
n=99 Participants
|
|
Fitzpatrick Skin Prototype
Type 3
|
6 Participants
n=99 Participants
|
|
Fitzpatrick Skin Prototype
Type 4
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1 and Month 3Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.
Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Outcome measures
| Measure |
Location: Left
n=24 Location
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
n=24 Location
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|---|
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Change in Dyspigmentation Spots
Baseline
|
48.3 Dyspigmentation Spots
Standard Deviation 12.1
|
46 Dyspigmentation Spots
Standard Deviation 11.8
|
|
Change in Dyspigmentation Spots
Month 1
|
42.2 Dyspigmentation Spots
Standard Deviation 13.8
|
42.5 Dyspigmentation Spots
Standard Deviation 10.9
|
|
Change in Dyspigmentation Spots
Month 3
|
46.1 Dyspigmentation Spots
Standard Deviation 13.1
|
42.9 Dyspigmentation Spots
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: Baseline, Month 1 and Month 3Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.
Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Outcome measures
| Measure |
Location: Left
n=24 Location
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
n=24 Location
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|---|
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Change in UV Spots
Baseline
|
29.4 UV Spots
Standard Deviation 9.9
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25.4 UV Spots
Standard Deviation 9.3
|
|
Change in UV Spots
Month 1
|
22.4 UV Spots
Standard Deviation 10.1
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21.6 UV Spots
Standard Deviation 9.7
|
|
Change in UV Spots
Month 3
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25.8 UV Spots
Standard Deviation 9.6
|
24.3 UV Spots
Standard Deviation 10.8
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PRIMARY outcome
Timeframe: Baseline, Month 1 and Month 3Population: The left and right side of each participant's face was analyzed separately resulting in an n of 48.
Numeric analysis of lentigines and melasma will be analyzed using the VISIA system. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Outcome measures
| Measure |
Location: Left
n=24 Location
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
n=24 Participants
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
|---|---|---|
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Change in Brown Spots
Baseline
|
62.5 Brown Spots
Standard Deviation 9.1
|
60.3 Brown Spots
Standard Deviation 10.8
|
|
Change in Brown Spots
Month 1
|
56.3 Brown Spots
Standard Deviation 8.8
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57.1 Brown Spots
Standard Deviation 8.8
|
|
Change in Brown Spots
Month 3
|
59.1 Brown Spots
Standard Deviation 10.1
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58.6 Brown Spots
Standard Deviation 9.1
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PRIMARY outcome
Timeframe: Month 1 and Month 3Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Outcome measures
| Measure |
Location: Left
n=24 Participants
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|---|
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Physician's Global Assessment Scores (PGAS)- Right Face
1 Month
|
3.45 score on a scale
Standard Deviation 1.23
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—
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Physician's Global Assessment Scores (PGAS)- Right Face
3 Month
|
3.60 score on a scale
Standard Deviation 1.35
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—
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PRIMARY outcome
Timeframe: Month 1 and Month 3Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Outcome measures
| Measure |
Location: Left
n=24 Participants
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
|---|---|---|
|
Physician's Global Assessment Scores (PGAS)- Left Face
Month 1
|
3.44 score on a scale
Standard Deviation 1.15
|
—
|
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Physician's Global Assessment Scores (PGAS)- Left Face
Month 3
|
3.72 score on a scale
Standard Deviation 1.32
|
—
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PRIMARY outcome
Timeframe: Month 1 and Month 3Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Outcome measures
| Measure |
Location: Left
n=24 Participants
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
|
Location: Right
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|---|
|
Physician's Global Assessment Score (PGAS)- Overall
Month 1
|
3.44 score on a scale
Standard Deviation 1.14
|
—
|
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Physician's Global Assessment Score (PGAS)- Overall
Month 3
|
3.66 score on a scale
Standard Deviation 1.28
|
—
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Adverse Events
Non-ablative f1927nm Laser
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-ablative f1927nm Laser
n=27 participants at risk
Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.
MOXI: Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
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|---|---|
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Musculoskeletal and connective tissue disorders
sprained ankle
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3.7%
1/27 • Number of events 1 • Data was collected within a 3 month period.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place