Efficacy and in use skin safety Of VB-001, an Antidandruff Hair Oil Regime In Comparison With Head & ShouldersÂ® Antidandruff Shampoo (P&G) Regime In Subjects With Moderate Adherent Dandruff Of The Scalp

Vyome Biosciences Private Limited0 个研究点目标入组 159 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Healthy males or females aged >= 15 years and <= 65 with a clinical diagnosis of moderate adherent dandruff of the scalp.
•2.Understand and willing to sign written informed consent in case of adults and written parental consent form and child assent form in case of children wherever applicable.
•3. Must be willing and able to comply with protocol, including measures of subject compliance.
•4. Must have active adherent dandruff of the scalp with a minimum score of 6 and not exceeding 14; baseline scaling scoring of at least 3 and not more than 4 of adherent flaking in at least one zone of the scalp (6 zones- 2 frontal, 2 parietal plus temporal and 2 occipital) .
•5. Investigators global assessment (IGA) for pruritis score of at least 1.
•6. Should not have used an antidandruff agent in the past 14 days.
•7. Willing to refrain from use of all other topical medications that would affect the results of the trial, including medicated shampoos/oils or antibiotics, during the treatment and observation periods (from day 0 to day 14).

•1. Pregnant or Lactating Women by history.
•2. No history of overt bacterial, viral or fungal infection of the head/neck.
•3. No history or presence of compromising dermatosis elsewhere on the skin.
•4. No actinically damaged skin
•5. Presence of any skin condition that would interfere with the diagnosis or assessment of adherent dandruff; e.g., psoriasis, acne, atopic dermatitis.
•6. Clinically significant systemic disease (e.g., immunological deficiencies, AIDS, current malignancies, uncontrolled diabetes mellitus).
•7. Use within 1 month prior to baseline of any treatment that would affect the results of the trial, including 1) systemic antifungals, 2) systemic steroids 3) systemic antibiotics 4) systemic anti-inflammatory agents or 5) cytostatic or immunomodulating drugs (e.g., cyclosporine, tacrolimus, pimecrolimus).
•8. Use within 2 weeks prior to baseline of any treatment that would affect the results of the trial, including 1) topical steroids 2) topical retinoids 3) topical anti-inflammatory agents 4)topical antibiotics or 5) topical treatment of adherent dandruff (e.g., coal tar preparations, antidandruff shampoos/oils/gels/creams/conditioners 6) antihistamines.

发起方

Vyome Biosciences Private Limited