CTRI/2018/01/011145已完成2 期
A double blind randomized placebo controlled clinical study to evaluate the efficacy and safety of an anti-dandruff shampoo in the treatment and prevention of moderate to severe dandruff on healthy human subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
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. Subjects (Female/Male) in generally good health.
- •2. Male and female subjects 18 to 40 years of age in th e ratio of 1:1.
- •3. Subjects should have an initial Area Severity Index of a least 32 and above at recruitment and baseline and should be clinically diagnosed as dandruff sufferers.
- •4. Length of the hair; for Males 7-9 cm and for females between shoulder to waist.
- •5. Subjects willing to give a written informed consent and come for regular follow up.
排除标准
- •1. Subjects with known allergies or sensitivities to ingredients contained in the test products.
- •2. Subjects with active dermatological conditions that can involve the scalp (eg.Psoriasis, exzema, ichthyosis, tinea capitis etc) other than the condition under study.
- •3. Chronic medication (e.g.antihistamines, antifungals, corticosteroids, topical steroids etc) that might influence the outcome of the study.
- •4. Subjects using systemic antifungal or corticosteroid therapy will be excluded unless such therapy has been discontinued for at least 30 days prior to the start of therapy.
- •5. Antipruritics (i.e antihistamines, anti-inflammatory agents, hydrocortinsone cream etc.) or topical antifungal therapy, selenium sulfide, zinc pyrithione, octopirox, salicylic acid, coal tar or corticosteroid therapy for the scalp/face must be discontinued for at least 14 days prior to the baseline.
- •6. Subjects with Atopic dermatitis and/or severe atopic dermatological background.
- •7. Subjects with prurigo nodularis and bleeding excoriations.
- •8. Subjects who have any pre-existing conditions that could interfere with the outcome of the study as determined by the investigator. Subjects with a concurrent disease that might place the subject at risk or prevent the subject from completing the study or an eye disease that might be subject to irritation from the shampoo.
- •9. Subjects who are pregnant or nursing (as confirmed by Urine test for the determination of Pregnancy). Continued use of birth control pills or implants and low therapeutic dosages of aspirin (325 mg or less) will be permitted and noted.
- •10. Subjects who are presently participating or participated in any other clinical study (i.e. dermal patch, use tests, investigational drug or devices etc.) 30 days before the start of the study.
- •11. Subjects viewed by the investigator as not being able to complete the study.
研究者
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