Trial Outcomes & Findings for Non-cutting Laser Therapy in the Treatment of Acne (NCT NCT00113425)
NCT ID: NCT00113425
Last Updated: 2016-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline and Week 10
Results posted on
2016-10-18
Participant Flow
Participant milestones
| Measure |
All Study Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-cutting Laser Therapy in the Treatment of Acne
Baseline characteristics by cohort
| Measure |
Treated Group Pulsed Dye Laser Therapy and Untreated Group
n=44 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
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Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
25.41 years
STANDARD_DEVIATION 8.46 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
3 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latina
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Papule Acne Lesions at Week 10
Change from Baseline on Treated Side
|
-4.63 papule acne lesions
Interval -7.43 to -1.83
|
|
Change From Baseline in Papule Acne Lesions at Week 10
Change from Baseline on Untreated Side
|
-0.13 papule acne lesions
Interval -2.83 to 2.57
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Pustule Acne Lesions at Week 10
Change from Baseline on Treated Side
|
-1.80 pustule acne lesions
Interval -5.05 to 1.45
|
|
Change From Baseline in Pustule Acne Lesions at Week 10
Change from Baseline on Untreated Side
|
-1.20 pustule acne lesions
Interval -4.49 to 2.09
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Cysts at Week 10
Change from Baseline on Treated Side
|
0.10 cysts
Interval -0.35 to 0.55
|
|
Change From Baseline in Cysts at Week 10
Change from Baseline on Untreated Side
|
0.07 cysts
Interval -0.3 to 0.43
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Closed Comedones at Week 10
Change from Baseline on Treated Side
|
-5.07 closed comedones
Interval -10.53 to 0.4
|
|
Change From Baseline in Closed Comedones at Week 10
Change from Baseline on Untreated Side
|
-1.17 closed comedones
Interval -7.52 to 5.19
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Open Comedones at Week 10
Change from Baseline on Treated Side
|
-1.00 open comedones
Interval -6.37 to 4.37
|
|
Change From Baseline in Open Comedones at Week 10
Change from Baseline on Untreated Side
|
-0.63 open comedones
Interval -6.01 to 4.75
|
PRIMARY outcome
Timeframe: Baseline and Week 10Outcome measures
| Measure |
All Study Participants
n=25 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Erythematous Macules at Week 10
Change from Baseline on Treated Side
|
-1.88 erythematous macules
Interval -7.73 to 3.97
|
|
Change From Baseline in Erythematous Macules at Week 10
Change from Baseline on Untreated Side
|
1.28 erythematous macules
Interval -4.66 to 7.22
|
PRIMARY outcome
Timeframe: Baseline and Week 10The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Acne Severity at Week 10
Change from Baseline on Treated Side
|
-0.90 units on a scale
Interval -1.3 to -0.5
|
|
Change From Baseline in Acne Severity at Week 10
Change from Baseline on Untreated Side
|
-0.30 units on a scale
Interval -0.65 to 0.05
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=29 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Papule Acne Lesions at Week 16
Change from Baseline on Treated Side
|
-1.79 papule acne lesions
Interval -5.98 to 2.39
|
|
Change From Baseline in Papule Acne Lesions at Week 16
Change from Baseline on Untreated Side
|
-0.97 papule acne lesions
Interval -4.32 to 2.39
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=29 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Pustule Acne Lesions at Week 16
Change from Baseline on Treated Side
|
-2.72 pustule acne lesions
Interval -6.65 to 1.2
|
|
Change From Baseline in Pustule Acne Lesions at Week 16
Change from Baseline on Untreated Side
|
-2.62 pustule acne lesions
Interval -6.25 to 1.01
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=29 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Cysts at Week 16
Change from Baseline on Treated Side
|
0.38 cysts
Interval -0.2 to 0.96
|
|
Change From Baseline in Cysts at Week 16
Change from Baseline on Untreated Side
|
0.24 cysts
Interval -0.33 to 0.82
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=29 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Closed Comedones at Week 16
Change from Baseline on Treated Side
|
-6.97 closed comedones
Interval -13.3 to -0.63
|
|
Change From Baseline in Closed Comedones at Week 16
Change from Baseline on Untreated Side
|
-4.07 closed comedones
Interval -9.12 to 0.98
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=29 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Open Comedones at Week 16
Change from Baseline on Treated Side
|
-4.79 open comedones
Interval -11.62 to 2.04
|
|
Change From Baseline in Open Comedones at Week 16
Change from Baseline on Untreated Side
|
-6.79 open comedones
Interval -13.88 to 0.29
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
All Study Participants
n=28 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Erythematous Macules at Week 16
Change from Baseline on Treated Side
|
-5.89 erythematous macules
Interval -12.12 to 0.34
|
|
Change From Baseline in Erythematous Macules at Week 16
Change from Baseline on Untreated Side
|
-2.50 erythematous macules
Interval -8.85 to 3.85
|
SECONDARY outcome
Timeframe: Baseline and Week 16The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Outcome measures
| Measure |
All Study Participants
n=27 Participants
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|
|
Change From Baseline in Acne Severity at Week 16
Change from Baseline on Treated Side
|
-1.07 units on a scale
Interval -1.69 to -0.45
|
|
Change From Baseline in Acne Severity at Week 16
Change from Baseline on Untreated Side
|
-0.52 units on a scale
Interval -1.07 to 0.04
|
Adverse Events
Treated Group Pulsed Dye Laser Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Untreated Group Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treated Group Pulsed Dye Laser Therapy
n=44 participants at risk
Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
|
Untreated Group Control
n=44 participants at risk
The contralateral side of the face remained untreated, thus serving as an internal control.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild Peeling
|
4.5%
2/44 • Number of events 2
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Transient Postinflammatory Hyperpigmentation
|
4.5%
2/44 • Number of events 2
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.3%
1/44 • Number of events 1
|
0.00%
0/44
|
Additional Information
Dr. Jeffrey Orringer
University of Michigan Dept of Dermatology
Phone: 734-936-4075
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place