Efficacy and Safety of 30% Salicylic Acid and 10% Nicotinamide Combined Therapy in Melasma: A Randomized Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- mMASI score
研究概览
简要总结
This prospective, randomized, placebo-controlled study evaluated the synergistic effects of 30% salicylic acid (SA) chemical peels and topical 10% nicotinamide (NAM) in 56 patients with moderate-to-severe melasma. Participants were divided into four groups: placebo control, SA peels alone (every 2 weeks for 8 sessions), NAM cream alone (twice daily for 16 weeks), and combination therapy (SA+NAM). The investigators investigated the efficacy and safety of 30%SA chemical peeling combined with 10% NAM.
详细描述
Background:Melasma is a common skin disease manifested as brown patches with symmetrical distribution and irregular boundaries. Chemical peeling with salicylic acid (SA) is widely used in the treatment of melasma. Nicotinamide (NAM) is a common whitening agent and has a good effect in the treatment of melasma. In the present study, the investigators investigated the efficacy and safety of 30%SA chemical peeling combined with 10% NAM.
Methods: 56 moderate-to-severe melasma patients were enrolled and randomly assigned into the control group, SA group, NAM group, and SA+NAM group. SA treatment was given at an interval of 2 weeks for 8 treatment sessions (week 0, 2, 4, 6, 8, 10, 12, 14). NAM was applied twice a day for 16w. Photos, mMASI score, and skin indices (TEWL, skin hydration, melanin index, erythema index, red areas score, and UV spots score) were assessed at 0, 2, 4, 6, 8,10,12, and 14 weeks. Side effects, efficacy and satisfactory scores were recorded.
Limitations: Retrospective single-center design and small sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and nonpregnant females, aged 18-60 years old;
- •Diagnosed with melasma;
- •Patients with good cognitive function and normal mental status;
- •Patients with good communication skills;
- •Voluntary participation in the study and signing of informed consent form.
排除标准
- •pregnancy or lactation;
- •pigmentation from other causes, such as hormonal dermatitis, cosmetic dermatitis, etc;
- •established allergy to SA or NAM;
- •active skin infection;
- •systemic diseases, such as immunodeficiency disease, diabetes, lupus erythematosus, etc;
- •having facial surgery, laser treatment, or whitening products in the past three months;
- •neurological or psychiatric disorders.
结局指标
主要结局
mMASI score
时间窗: From enrollment to week 16
The Primary outcomes were pre-defined as mMASI score and percent change in mMASI score, which was calculated as (mMASI at baseline-mMASI after treatment)/ mMASI at baseline × 100% and was graded as recovery (≥90%), obvious improvement (60-89%), improvement (20-59%), and no improvement (\<20%).
次要结局
- transepidermal water loss(From enrollment to week 16)
- erythema index(From enrollment to week 16)
- melanin index(From enrollment to week 16)
- The skin hydration(From enrollment to week 16)
- Actinic damage (UV spots)(From enrollment to week 16)
- patient satisfaction evaluation(week 16)
- melanin index(From enrollment to week 16)
- The skin hydration(From enrollment to week 16)
- transepidermal water loss(From enrollment to week 16)
研究者
Weihui Zeng
Professor
Second Affiliated Hospital of Xi'an Jiaotong University