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

NCT ID: NCT02126657

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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)

Conditions

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Acne Scars

Keywords

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Acne scars 70% Glycolic acid peel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Single arm study - pre and post peel assessment

Group Type OTHER

70% glycolic acid

Intervention Type DRUG

Interventions

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70% glycolic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Central Contacts

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Sam SY Yang, Dr

Role: CONTACT

Phone: 85333992

Email: [email protected]

Facility Contacts

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Sam Yang, Dr

Role: primary

Other Identifiers

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2013/01230

Identifier Type: -

Identifier Source: org_study_id