MedPath

Checking safety and efficacy of product

Not Applicable
Registration Number
CTRI/2024/03/064373
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.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 & scalp is healthy on the studied anatomic unit

4.Having dry scalp & Having moderate to severe dandruff

Exclusion Criteria

1.For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three

months.

2.Having refused to give her assent by not signing the consent form.

3.Taking part in another study is liable to interfere with this study.

4.Having 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 her cosmetic habits except those required by the protocol in the 14 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 dandruff, SafetyTimepoint: Baseline, 14 days, 28 days
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: NA
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