Safety and efficacy assessment of hair care Product on skin

Not yet recruiting

• Conditions: having moderate to severe hair fall, moderate to severe dandruff and having dry scalp & wavy hair

• Registration Number: CTRI/2023/07/055079
• Lead Sponsor: Incnut Lifestyle Retail Pvt Ltd

Brief Summary

OBJECTIVE - The objective of this study will be to evaluate &compare the in-vivo safety and efficacy of a Hair Care Regime Versus a HairCare Formulation in terms of hair growth (hair length), reduction in hair falland reduction in dandruff on healthy female subjects

POPULATION - 72 Female subjects will be selected for the study.The subjects selected for this study are healthy females, aged between 18 and45 years old having moderate to severe hair fall, moderate to severe dandruffand having dry scalp & wavy hair. The study will be conducted in 2 groups.I. Group A: This group will include 36 female subjects who will be using theTest Regime (Product A to Product E). II. Group B: This group will include 36female subjects who will be using Product F.

DURATION - 56 days including the 28 days of conditioningphase and 28 days of treatment phase

STUDY DESIGN -  Single blind study.

Comparative study.(For hair growth results obtained in treatment phase will be compared with thatof natural growth in conditioning phase)

Subjects served as their own reference for the intra-groupcomparison (evaluation of the efficacy on time of each product) and for theinter-group comparison (comparison of the efficacy of the test regime &with test product)

The evaluation is performed using-

Subject’s Self Evaluation ▪ Dermatological Evaluation:Safety ▪ Dermatological Evaluation: Efficacy ▪ Measurement of Hair Growth byBleaching Technique ▪ Counting of Fallen Hair after Standardized Combing ▪Photographs of scalp build-up by Trichoscope

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-20
• Last Update Posted: 2023-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 72

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 scar….) 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 …) 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 fever…) 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 … • 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 …) • Having taken a food supplement with an anti hair loss claim • Having taken an iron based treatment. 20) In the previous 30 days • Having applied a product with an anti hair loss claim (due to breakage). 21) In the two last days preceding the first day of the study • Having applied a shampoo with anti hairfall claim (i.e., having washed their hair) 22) Refusing to follow the restrictions below during the study:.
• Do not start, change or stop a hormonal treatment.
• Do not start a medicinal treatment which could influence the cycle of the hair (anti-hair loss treatment or treatment inducing hair loss).
• Do not use local anti-hair loss treatment nor anti-hair loss cosmetic products.
• Do not keep hair length less than 5 cm.
• Do not have hair coloured, lightened or permed at the hairdresser or at home.
• Do not perform a traumatic hairstyle which could damage hair.
• Do nor perform too hot brushing or with a too important frequency.
• The day of measurenent: Untangle the hair (slightly) at home, before coming to the site for observation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hair growth (hair length), reduction in hair	Baseline, 14 days, 28 days
fall & reduction in dandruff	Baseline, 14 days, 28 days

Secondary Outcome Measures

Name	Time	Method
No	Not applicable

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in