MedPath

Assessment of safety and efficacy of product

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Reduction in hair fall, SafetyTimepoint: Baseline, 14 days, 28 days
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: NA
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