The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Primary Purpose
Acne Scars
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
70% glycolic acid
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars focused on measuring Acne scars, 70% Glycolic acid peel
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
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Single arm study - pre and post peel assessment
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02126657
First Posted
April 28, 2014
Last Updated
April 28, 2014
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02126657
Brief Title
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
Keywords
Acne scars, 70% Glycolic acid peel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm study - pre and post peel assessment
Intervention Type
Drug
Intervention Name(s)
70% glycolic acid
Primary Outcome Measure Information:
Title
Efficacy Assessment
Description
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)
Time Frame
3 months
Title
Safety Assessment
Description
) 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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam SY Yang, Dr
Phone
85333992
Email
samsyyang@gmail.com
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Yang, Dr
Phone
85333992
Email
samsyyang@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
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