MedPath

Safety and Efficacy assessment of cosmetic product

Not Applicable
Registration Number
CTRI/2023/10/058576
Lead Sponsor
Mosaic wellness pvt ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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
NameTimeMethod
Reduction in dandruff after one washTimepoint: Baseline, 24 hours after application, 48 hours after application
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: Not applicable
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