MedPath

Safety and efficacy assessment of hair care Product on ski

Not Applicable
Registration Number
CTRI/2023/07/055079
Lead Sponsor
Incnut Lifestyle Retail 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 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) Between 18 and 45 years of age.

4) Skin & scalp is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)

5) Having moderate to severe hair fall.

6) Having moderate to severe dandruff.

7) Having Dry scalp and Wavy hair.

8) Subjects must complete a Questionnaire inputing the scalp type and hair type mentioned. https://vedix.com/pages/vpq

Exclusion Criteria

1)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)

2) Having a progressive asthma (either under treatment or last fit in the last 2 years)

3) Being epileptic

4) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

5) Having cutaneous hypersensitivity

6) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products

7) 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)

8) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months

9) Having changed his/her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.

10) Having applied a hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti hairfall claim or hair growth claim)

11) Refusing to follow the restrictions below during the study: - Do not take part in any family planning activities leading to pregnancy and breastfeeding - Do not take part in another study liable to interfere with this study. - Do not take 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) - Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. - During the study: Do not use other hair care products than the tested products to the studied areas (except the neutral shampoo without anti hairfall claim or hair growth claim) - The day of the measurements: No hair care must be used including test product. Having untangled their hair at home, before coming to the site for observations, the first day of the study.

12)Having naturally fair or white hair (Which will interfere the evaluation)

13) Having a dermatosis on the scalp

14) Having surgery history on the scalp (micro transplants â?¦)

15) Refusing the bleaching of two areas of the scalp of approx. 40 hairs, the first day of the study.

16) Refusing the pluking of approx. 10 hairs, during the entire study

17) Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high feverâ?¦)

18) In the previous 6 months • Having undergone the Minoxidil treatments • Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide) • Having undergone one of the following treatments known to : induce hair loss : retinoids, anti-coagulants, anti-convulsive drugs, chemotherapy, beta-blocking agents, non steroidal anti-inflammatory drugs, corticoids â?¦ • Having modified her hormonal contraception

19) In the previous 3 months • Having undergone a local or general anti hair loss treatment (Biotine, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc â?¦) • Having taken a food supplement with an anti hair loss claim • Having taken an iron

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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