Safety and Efficacy assessment of cosmetic product

Not yet recruiting

• Conditions: having mild to moderate dandruff

• Registration Number: CTRI/2023/10/058576
• Lead Sponsor: Mosaic wellness pvt ltd

Brief Summary

OBJECTIVE :The objectiveof this study will be to evaluate invivo safety and efficacy of a Hair careregime in terms of reduction in dandruff after two washes on healthy humansubject.

 The evaluation is performed using:Subject’s Self Evaluation,Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation:Efficacy

 The study lasts 7 days including the 2 daysconditioning phase and 5 days treatment period.

 POPULATION : 36 subjects (18male & 18 female) are selected for the study.

The subjects selected for thisstudy are healthy male & female subjects aged between 18 and 35 years old,having mild to moderate dandruff

Test Products: Regime with Anti Dandruff Lotionand Anti Dandruff Shampoo

Anti Dandruff lotion will be applied once at nighton day 1 (T0) and day 4(T+3 days).

Anti dandruff shampoo will be used once in a day onwhole scalp on day 2(T+1 day) and day 5(T+4 days).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-18
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 1Indian / Asian male and female subjects.
• 2Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4Having mild to moderate dandruff.

Exclusion Criteria

• 1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give his/ her assent by not signing the consent form.
• 3Taking part in another study is liable to interfere with this study.
• 4Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6Having a progressive asthma (either under treatment or last fit in the last 2 years) 7Being epileptic 8Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9Having cutaneous hypersensitivity 10Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11Following a chronic or intermittent medicinal treatment comprising any of the following products :aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 13Having changed his/her cosmetic habits except those required by the protocol in the 3 days preceding the start of the study on the studied anatomic unit 14Having applied a hair care products and cosmetic products on the studied area the first day of the study (except hair washed with the provided neutral shampoo one day prior to the day of visit.) 15Having applied a hair care product on study visits including test products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in dandruff after one wash	Baseline, 24 hours after application, 48 hours after application

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in