Assessment of safety and efficacy of product
- Conditions
- Health Condition 1: L659- Nonscarring hair loss, unspecified
- Registration Number
- CTRI/2024/03/064647
- Lead Sponsor
- BEAUTY GARAGE INDIA PVT. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Asian Indian humans 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 oily scalp and moderate to severe hair fall
1.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 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.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)
11.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6
months
12.Having changed her cosmetic habits except those mentioned in protocol in the 7 days preceding
the start of the study on the studied anatomic unit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in hair fall, SafetyTimepoint: Baseline, 14 days, 28 days
- Secondary Outcome Measures
Name Time Method ilTimepoint: NA