Randomized controlled comparative study to evaluate the efficacy and tolerability of Test Regimen in the treatment of facial hyperpigmentation (Melasma) over 12 weeks

Beiersdorf AG1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2024年12月23日最近更新: 2024年12月12日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Beiersdorf AG
入组人数: 45
试验地点: 1
主要终点: Change in mMASI and change from Baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Melasma is a common skin condition characterized by the appearance of dark, irregular patches, primarily on the face. This dermatological study is an interventional, randomized controlled trial designed to compare the efficacy and tolerability of a new depigmenting cosmetic formulation for managing facial hyperpigmentation (melasma) over a 12-week period, with a total of 6 study visits. Participants will be fully informed about the study design and treatment plan and will have sufficient time to review the informed consent form (ICF). The dermatologist will assess the severity of melasma using the mMASI scale and determine the type of melasma with a Woodâ€™s lamp examination. Eligible subjects will be selected based on the inclusion and exclusion criteria. Participants will be instructed to wash their faces with the provided facewash and allow a 10-minute acclimatization period. After this, baseline assessments will be conducted, and test regimens, along with a subject diary, will be provided. Similar assessments will be repeated at weeks 3, 4, 8, and 12. At the conclusion of the study, the test regimens and subject diaries will be collected, and participants will be asked to complete the study exit form.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 20.00 Year(s) 至 50.00 Year(s)（—）
性别: All

入选标准

•Adult subjects in general good health as determined from recent medical history, general physical examination, dermatological assessment, Subjects of Phototype from III to VI.
•Subjects diagnosed with mild to moderate Melasma, Subjects who have not used contraindicated products (irritants, other depigmenting agents) in the past 8 weeks (as per the treatment category, as per dermatologistsâ€™ discretion, Subjects willing to stop all other skin care products and diligently follow the pro vided treatment plan, Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face, Subject who agrees not to use any other product/treatment/home remedy/ except the provided products on their face during the study period other than the test reg imen, Subjects who agree not to carry out bleaching or any other procedures including facial etc.
•on the face during the study period, Subjects who agree not to be exposed to excessive sunlight.
•(Sun exposure not more than half an hour daily and during that time use of an umbrella to cover face), Subjects willing to give a voluntary written informed consent, photography re lease and agree to come for regular follow-up, Subjects willing to abide by and comply with the study protocol.
•Willing to sign a photography release In case of hormonal treatment/contraception, subjects who have been on a stable dose for at least 6 months and agree not to change or stop their treatment/ contraception medication/dose.

排除标准

•Subject with any other signs of significant local irritation or skin disease, Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study, Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to the study.
•Subjects who are pregnant or breastfeeding (self-declared).
•Subjects with childbearing potential or have plans of pregnancy (excluded by a urine pregnancy test).
•Subjects who recently had a skin-lightening procedure in the past 8 weeks or oral photosensitizers or who underwent phototherapy in the past 1 month wash out.
•Subjects using corticosteroids or under antiepileptic medications for the previous six months.
•Subjects with a history of any other dermatosis of the face or known photosensi tivity or undergoing topical treatment with Sun Protection Factor in the past 1 month.
•Subjects who are exposed to the sun on a regular basis, frequent tanning salons or foresee exposure to the sun during the study or any facial procedure planned during the course of the study, Subjects with any other active skin condition that may interfere with the study re sults.
•Subjects with a known history of allergenic reactions to any components of the products.
•Subjects who have participated in any other clinical trial in the last 3 months.
•Subjects with Inadequate language proficiency (spoken and written) Subjectâ€™s Inability to be placed in the photography system Subjects with Severe psychological illness or intellectual inability to understand the study.