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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02126657
• Other study ID #: 2013/01230
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 28, 2014
• Last updated: April 28, 2014
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Sam SY Yang, Dr
• Phone: 85333992
• Email: samsyyang[@]gmail.com
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Scars

Intervention

Drug:
• 70% glycolic acid

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes