Clinical trial NCT02126657: The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Official title: Phase 2 Study of the The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acne Scars
Keywords: Acne scars
70% Glycolic acid peel
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a single application. The study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited. Potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. We believe that this treatment will be highly beneficial to patients with post acne scarring.

This chemical peel regime has good efficacy and safety profile for the treatment of acne scars.

Detailed description: Primary endpoints:

1. ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. Two blinded evaluators compare and rate the photograph using ECCA score.
2. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar

Secondary endpoints:

1. Postacne hyperpigmentation index (PAHPI)

   -Each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total PAHPI score, ranging 6 to 22.
2. Safety Assessment (This is an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring vi. Assessment based on patient and doctor global assessment (global assessment from 1 - 10)

Eligibility criteria: Inclusion Criteria:

1. Atrophic scars
2. Skin type I to IV

Exclusion Criteria:

1. Pregnancy, breastfeeding
2. Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex
3. Known hypersensitivity
4. Previous keloids
5. Laser ablative procedures within the last month
6. Chemical peels within the last 6 months
7. Used oral retinoids in the past 6 months
8. Used topical retinoids in the past one week
9. Used scrub, AHA, skin irritant for the past 24h
10. Presence of facial warts or fungal infections
11. Photoallergies
12. Prior poor reaction to a chemical peel
13. Radiotherapy
14. Skin type V and VI
15. Patients with predominantly ice pick and boxcar scars

Primary outcomes:
measure: Efficacy Assessment
timeFrame: 3 months
measure: Safety Assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References: