Acne Scars Clinical Trial
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
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.
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)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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