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

NCT02126657 | Unknown Phase 2

• 1 other identifier: 2013/01230
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars

Keywords

Acne scars; 70% Glycolic acid peel

Outcome Measures

Primary Outcomes (2)

• Efficacy Assessment

  1. 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 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)

  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

Study Arms (1)

Single Arm

OTHER

Single arm study - pre and post peel assessment

Drug: 70% glycolic acid

Interventions

70% glycolic acid DRUG

Single Arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Atrophic scars
• Skin type I to IV

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

glycolic acid

Central Study Contacts

Sam SY Yang, Dr

CONTACT

85333992; samsyyang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

SG (1)