The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars

Study Overview
=================
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: 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. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar Secondary endpoints: 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. 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)

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

Conditions
-----------------
Acne Scars

Intervention / Treatment
-----------------
* Drug: 70% glycolic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrophic scars Skin type I to IV Exclusion Criteria: Pregnancy, breastfeeding Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex Known hypersensitivity Previous keloids Laser ablative procedures within the last month Chemical peels within the last 6 months Used oral retinoids in the past 6 months Used topical retinoids in the past one week Used scrub, AHA, skin irritant for the past 24h Presence of facial warts or fungal infections Photoallergies Prior poor reaction to a chemical peel Radiotherapy Skin type V and VI Patients with predominantly ice pick and boxcar scars

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single arm study - pre and post peel assessment | Drug: 70% glycolic acid<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessment | ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars V-shaped atrophic scars with diameter <2 mm: 15 U-shaped atrophic scars with a diameter of 2-4 mm: 20 M-shaped atrophic scars with diameter >4 mm: 25 Superficial elastolysis: 30 Hypertrophic scars with a <2-year duration: 40 Hypertrophic scars of >2-year duration: 50 A semi-quantitative scoring of number of each scar will be performed No scars: 0 Less than five scars: 1 Between five and 20 scars: 2 More than 20 scars: 3 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) | 3 months | 
| Safety Assessment | ) Safety Assessment (This is also an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne scars, 70% Glycolic acid peel