Phase 2 Study of the Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of Parameters for Photoaging
研究概览
简要总结
Our study involves the evaluation of a high potency peel in its efficacy for skin rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency peel 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety.
AIM We aim to qualitatively evaluate its efficacy and safety profile.
Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will result in improvement of the features of photoaging with few side effects.
详细描述
- Assessment of photoaging to compare using photography A and E - for static analysis.
For each element from ii to xi, a rating of nil (0), mild (l), moderate (2), and severe (3) for each category was made by the same evaluating physician.
i. Physician VAS scale - assessment of wrinkles prepeel, post peel (Score 1 -10).
ii.Fine peri-orbital wrinkles (less than 1 mm in width or depth) (FPW); iii.Course peri-orbital wrinkles (greater than 1 mm in width and depth) (CPW); iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma defined as blotchy, brown, epidermal macules with indistinct margins; vii.Solar lentigines defined as dark brown macules with distinct margins measuring from 3 to 10 mm; viii.Solar keratoses defined as diffuse erythema with keratotic adherent scaling; ix.Guttate hypomelanosis defined as localized macules of absent melanin measuring from 3 to 10 mm in diameter; x.Poikiloderma defined as a symmetrical reddish-brown pigmentation of the neck, typically sparing the sub-mental area;
The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement. 2. Safety profile assessment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Photoaging Grade 2-4 (face) Skin type I - IV
排除标准
- •Pregnancy, breast feeding Active dermatitis on the face, rosacea, allergic rhinitis, herpes Known hypersensitivity Previous Keloids Laser ablative procedures within the last one month Chemical Peels in the last 6 months Used oral retinoids in the last 6 months Used topical retinoids in the past one week Used Scrub, Alpha Hydroxy Acid, skin irritant for the past 24h Presence of facial warts, fungal infections Photoallergies Prior poor reaction to a chemical peel Radiotherapy Skin type V and VI
研究组 & 干预措施
Single Arm
Single arm of 10 patients - efficacy and safety assessed pre and post peel
干预措施: 70% glycolic acid (Drug)
结局指标
主要结局
Assessment of Parameters for Photoaging
时间窗: 3 months
i. Physician VAS scale - Score 1 -10. ii.Fine peri-orbital wrinkles iii.Course peri-orbital wrinkles; iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma vii.Solar lentigines viii.Solar keratoses ix.Guttate hypomelanosis x.Poikiloderma The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement.
Safety Assessment
时间窗: 3 months
Safety profile assessment * redness, swelling, oozing, hyperpigmentation, scarring * each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe
次要结局
未报告次要终点