PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Degree of Hyperpigmentation at 12 Weeks
研究概览
简要总结
A randomized controlled split-face pilot study was planned to investigate the preventive effect of tretinoin 0.05% cream on hyperpigmentation during phototherapy in patients with vitiligo.
详细描述
Vitiligo is a chronic depigmentation disorder characterized by well-demarcated white macules and patches, reflecting selective melanocyte destruction. Hyperpigmentation at the treated areas is one of the limitations of phototherapy. Topical tretinoin (retinoic acid) has been well established to be effective for skin pigmentary disorders including melasma. This study aims to investigate the preventive effect of topical tretinoin on hyperpigmentation during phototherapy. A randomized controlled trial based on split-face was planned. The left/right face will be randomized to either tretinoin or placebo cream treatment groups. All lesions will be treated using phototherapy twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: older than 19
- •A patient with stable non-segmental vitiligo
- •A patient with symmetrical vitiligo lesions on face
- •A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
- •A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.
排除标准
- •Age: lower than 20
- •A pregnant or lactating patient
- •A patient with active or spreading vitiligo
- •A patient who cannot understand the study or who does not sign the informed consent
- •Women of childbearing potential not using an effective method of contraception properly
研究组 & 干预措施
Tretinoin 0.05% cream group
Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night
干预措施: Tretinoin 0.05% cream (Drug)
Tretinoin 0.05% cream group
Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night
干预措施: Placebo cream (Drug)
Placebo
PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night
干预措施: Tretinoin 0.05% cream (Drug)
Placebo
PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night
干预措施: Placebo cream (Drug)
结局指标
主要结局
The Degree of Hyperpigmentation at 12 Weeks
时间窗: at 12 weeks
The degree of hyperpigmentation will be assessed as L\* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
次要结局
- Number of Participants Who Showed ≥75% Repigmentation(change from Baseline and at 12 weeks)
研究者
Jung Min Bae
Department of Dermatology, St. Vincent's Hospital
The Catholic University of Korea