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
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy Assessment
研究概览
简要总结
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.
详细描述
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. 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Atrophic scars
- •Skin type I to IV
排除标准
- •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
研究组 & 干预措施
Single Arm
Single arm study - pre and post peel assessment
干预措施: 70% glycolic acid (Drug)
结局指标
主要结局
Efficacy Assessment
时间窗: 3 months
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)
Safety Assessment
时间窗: 3 months
) 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
次要结局
未报告次要终点