A Randomized, Double-Blind, Placebo- Controlled, Multicentred Study to Evaluate the Efficacy and Safety of a Topical Test Product in Trial Participants with Non-Segmental Vitiligo.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
Vitiligo is a chronic, acquired depigmenting disorder of the skin characterized by the selective destruction of melanocytes, leading to well-demarcated white patches. It affects approximately 0.5–2% of the global population and can occur at any age, with a multifactorial etiology involving genetic, autoimmune, oxidative stress, and neurogenic factors.
Non-segmental vitiligo (NSV), the most common clinical form, is typically bilateral and symmetrical, with lesions that may progress over time and involve multiple body sites. NSV is considered an autoimmune condition, often associated with other autoimmune diseases, and is characterized by an unpredictable course with periods of stability and activity. This study aims to evaluate the therapeutic efficacy of the test product in non-segmental vitiligo (NSV), with specific focus on the extent of repigmentation, stabilization of disease progression, and improvement in patient-reported outcomes.
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
- •Male & Female trial participants in general good health.
- •Trial participants in the age group of 18-65 years (both ages inclusive).
- •Trial participants with Fitzpatrick phototypes III to V.
- •Participant has not received phototherapy within the past 3 months, has not used any topical vitiligo treatment within the past 4 weeks, and is not currently undergoing any vitiligo treatment prior to the Screening Visit.
- •Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the test sites as determined by the dermatologist.
- •Trial participants who agree not to use any other product/treatment/home remedies except the provided products during the study period.
- •Trial participants who agree not to initiate any new dietary supplements, herbal products, or over-the-counter medications targeting skin pigmentation during the study period.
- •Trial participants agree to not change their normal hygiene and cleansing routine such as increasing or decreasing shower frequency or changing the soap or cleanser they have been using safely for the 30 days prior to enrolment.
- •Trial participants willing to avoid direct sun exposure (Use umbrella, Cap, Hat if stepping out in direct sunlight).
- •Trial participants who agree not to carry out bleaching or any other cosmetic/dermatologic procedures (including facials, chemical peels, or laser treatments) during the study period.
- •Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
排除标准
- •Trial participant with any other signs of significant local irritation or skin disease at or near the target area.
- •Trial participant currently taking any medication, which the Investigator believes may influence the study outcomes.
- •Trial participant having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •Trial participants unwilling to discontinue other topical products for the study duration.
- •Trial participant allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
- •Trial participants who are pregnant and lactating (self-declared).
- •Trial participants who are currently under/planning to start hormone replacement therapies (HRT) or hormonal birth control less than 3 months prior to the study entry.
- •Any condition or circumstance that, in the opinion of the investigator, would interfere with the participant’s ability to comply with the study protocol.
- •Trial participants who are an employee of sponsor or CRO.
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd