Effectiveness of Fortnightly 35 percent Glycolic Acid Peel Versus Daily 12 percent Glycolic Acid Cream in the Treatment of Melasma: A Prospective, Comparative, Two-arm, Double-blind, Randomised Controlled Study at a Tertiary Care Centre in Mandya
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • Change in MASI (Melasma Area and Severity Index) score.
研究概览
简要总结
This study is a prospective hospital-based, double-blind, randomized controlled trial designed to compare the efficacy of fortnightly 35% glycolic acid peel with daily 12% glycolic acid cream in the treatment of melasma. A total of 60 patients aged 18–65 years will be randomized into two groups of 30 each: Group A will receive 35% glycolic acid peels every two weeks along with a placebo cream, while Group B will receive daily 12% glycolic acid cream with a placebo peel. Both patients and investigators will remain blinded to the treatment allocation, with placebos used to maintain blinding. All participants will be advised regular use of sunscreen. The primary objective is to evaluate and compare the reduction in pigmentation using the Melasma Area and Severity Index (MASI) score at baseline, 4, 8, and 12 weeks. Secondary objectives include assessing the impact of treatment on quality of life, recording adverse events, and comparing efficacy across different melasma types (epidermal, dermal, mixed). By directly comparing peel versus cream therapy, this study aims to provide valuable evidence on which modality offers better clinical outcomes, safety, and cost-effectiveness, thereby guiding dermatologists in optimizing melasma management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed with melasma.
- •Patients aged 18-65 years of both sexes.
- •Patients who are not on active treatment and not taken any treatment for melasma in the past 1 month.
- •Patients willing to give informed consent to participate in the study.
排除标准
- •Pregnant and lactating females.
- •Hypersensitivity to the peeling agent.
- •Skin infection at the site of Melasma (herpes, pyoderma, and folliculitis).
- •Patients with topical steroid damaged face.
- •Patients with rosacea, systemic lupus erythematosus and other photodermatoses.
- •Patients consuming Oral contraceptive pills.
- •Patients with unrealistic expectations.
- •Patients consuming Isotretinoin tablets and other drug which can cause and exuberate melasma.
- •History of keloids or hypertrophic scars.
- •Concomitant skin or systemic disease.
结局指标
主要结局
• Change in MASI (Melasma Area and Severity Index) score.
时间窗: • From baseline( Day 0) to 4, 8, and 12 weeks.
次要结局
- Grading of subjective improvement in pigmentation, assessed as no response, mild, moderate, good, or very good response based on MASI score reduction.(Before treatment and at the completion of the study (end of 12 weeks, after the sixth peel/last follow-up visit))
研究者
Dr Shashikumar B M
Mandya institute of medical sciences
