Acne Scars - Mixed Atrophic and Hypertrophic
Conditions
Brief summary
To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.
Interventions
DEVICEHybrid fractional laser
two treatments given one month apart
OTHERAlastin Regenerating Skin Nectar with TriHex Technology
applied twice daily
OTHERCetaphil face cream
applied twice daily
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or females * age 18 and older * with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman & Baron qualitative global acne scar grading system
Exclusion criteria
* treatment to face with any energy device within 6 months * tanning within 7 days * dermabrasion or chemical peel within 3 months * current use of systemic retinoids * keloidal scaring in the treatment area * use of systemic steroids within 6 months * use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Erythema | baseline to day 34 | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Skin Barrier Function | baseline to day 34 | Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm. |
| Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | baseline to day 90 | The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Alastin Regenerating Skin Nectar With TriHex Technology Hybrid fractional laser: two treatments given one month apart
Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily | 6 |
| Control: Cetaphil Hybrid fractional laser: two treatments given one month apart
Cetaphil face cream: applied twice daily | 4 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Experimental: Alastin Regenerating Skin Nectar With TriHex Technology | Control: Cetaphil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 34.6 years | 31.5 years | 33.4 years |
| Race/Ethnicity, Customized African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 6 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 6 | 1 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 4 |
Outcome results
Primary
Mean Change From Baseline in Erythema
A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.
Time frame: baseline to day 34
Population: One participant in the control group, discontinued prior to Day 30.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Mean Change From Baseline in Erythema | -1.687 units on a scale | Standard Error 4.461 |
| Control | Mean Change From Baseline in Erythema | 5.730 units on a scale | Standard Error 4.461 |
Primary
Mean Change From Baseline in Erythema
A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.
Time frame: baseline to day 4
Population: One participant in the control group, discontinued prior to Day 30.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Mean Change From Baseline in Erythema | 1.768 units on a scale | Standard Error 4.218 |
| Control | Mean Change From Baseline in Erythema | 5.596 units on a scale | Standard Error 4.218 |
Secondary
Mean Change in Skin Barrier Function
Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm.
Time frame: baseline to day 34
Population: One participant in the control group discontinued prior to second laser treatment, Day 30.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Mean Change in Skin Barrier Function | Day 4 | 6.502 g/m^2h | Standard Error 6.65 |
| Experimental | Mean Change in Skin Barrier Function | Day 34 | 2.858 g/m^2h | Standard Error 7.233 |
| Control | Mean Change in Skin Barrier Function | Day 4 | 21.59 g/m^2h | Standard Error 6.65 |
| Control | Mean Change in Skin Barrier Function | Day 34 | 39.07 g/m^2h | Standard Error 7.233 |
Secondary
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported.
Time frame: baseline to day 90
Population: One participant in the control discontinued prior to Day 90.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | Improved | 4 participants |
| Experimental | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | No Change | 2 participants |
| Experimental | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | Much Improved | 0 participants |
| Control | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | Improved | 1 participants |
| Control | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | No Change | 1 participants |
| Control | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | Much Improved | 1 participants |