CTRI/2018/05/013567已完成未知
An open label, single arm, monocentric study to evaluate the safety and efficacy of the test product VB-3222 on healthy male and female subjects aged 18-65 years with moderate adherent dandruff on scalp. - NI
Vyome Biosciences Pvt Ltd0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female subjectsâ?? in general good health.
- •2.Subjects in the age group 18-65 years (both the ages inclusive).
- •3.Subjects with at least moderate dandruff at baseline (score of >= 24) as per ASFS. Each zone (8) will have a score of 2 or more.
- •4.Subjects with the score of at least 1 for pruritus as per Investigator global assessment (IGA).
- •5.Subjects willing to refrain from any use of anti-dandruff shampoo or antidandruff treatment during the study duration.
- •6.Female subjects of child bearing potential willing to use effective birth control during the study duration and following 30 days after their final study visit.
- •7.Subjects willing to give a voluntary written informed consent and agree to come for a regular follow up visit.
- •8.Subjects willing to abide by and comply with the study protocol.
- •9.Subjects who have not participated in a similar investigation in the past four weeks.
排除标准
- •1.Subjects having any scalp condition that would interfere with the diagnosis or assessment of dandruff (e.g., active scalp disorder such as psoriasis, DLE, SLE, lichen planus, lichen planopilaris and Eczema).
- •2.Female subjects who are pregnant or lactating or nursing as established by medical history or planning to become pregnant during the study period.
- •3.Subjects with the history of or presence of significant skin disorder (such as but not limited to severe seborrheic dermatitis, atopic dermatitis, psoriasis or skin cancer) which will interfere with the test readings.
- •4.Subjects with history of allergy to soaps, lotions, shampoos, topical drugs of same class as the study medication.
- •5.Subjects with history of hypersensitivity or allergy to zinc pyrithione and / or any component of the test product.
- •6.Subjects on
- •Topical steroids
- •Topical antifungal treatments including OTC preparations
- •Topical anti-inflammatory agents
- •Topical antibiotics
- •Antidandruff or antiseborrheic topical treatment
- •(e.g., antidandruff shampoos, anti-seborrheic shampoos and coal tar preparations).
- •7.Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
- •8.Chronic illness which may influence the cutaneous state.
- •9.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. As per investigatorâ??s discretion.
研究者
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