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Safety and Efficacy assessment of cosmetic product

To evaluate invivo safety and efficacy of a Hair care formulation in terms of reduction in dandruff after one wash on healthy human subject - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058576
Enrollment
36
Registered
2023-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Shampoo: Hair are washed with the sufficient amount of shampoo. this application is done only once at site for the period of 48 hours. Control Intervention1: Nil: Not applicable

Sponsors

Mosaic wellness pvt ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Indian / Asian male and female subjects. 2 Healthy 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) 3 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4 Having mild to moderate dandruff.

Exclusion criteria

Exclusion criteria: 1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give his/ her assent by not signing the consent form. 3 Taking part in another study is liable to interfere with this study. 4 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6 Having a progressive asthma (either under treatment or last fit in the last 2 years) 7 Being epileptic 8 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9 Having cutaneous hypersensitivity 10 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11 Following 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) 12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 13 Having 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 14 Having 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.) 15 Having applied a hair care product on study visits including test products.

Design outcomes

Primary

MeasureTime frame
Reduction in dandruff after one washTimepoint: Baseline, 24 hours after application, 48 hours after application

Secondary

MeasureTime frame
NilTimepoint: Not applicable

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026