Safety and efficacy assessment of Product on skin

Not yet recruiting

• Conditions: having moderate to severe dandruff and hairfall

• Registration Number: CTRI/2022/02/040653
• Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary

Objective: The objective of this study will be to evaluate in-vivo safety and efficacy of hair care formulation in terms of reduction in Hair Fall and Anti-dandruff effect on healthy female & male subjects

Duration of study: 35 days study (The study lasts 35 days including the 7 days conditioning phase and 28 days application period)

Kinetics: Screening (T-7 days), T0, T+14 days and T+28 days

Population: 36 (18 Females & 18 Males) volunteers

The evaluation is performed using:

1. Subject’s Self Evaluation,

2. Dermatological Evaluation: Cosmetic Acceptability,

3. Dermatological Evaluation: Efficacy

4. Counting of fallen hair after standardized combing

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-24
• Study Start: 2022-03-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Having moderate to severe hair fall.
• Having Moderate to severe dandruff (where 0 is None, 1 is Slight, 2 is Mild, 3 is Moderate, 4 is Severe) 3.
• Suffering with hair thinning on subject assessment basis.
• For female: Having at least shoulder length hair.
• Having washed their hair with provided neutral shampoo, 48 hours before the first day of the study with the provided nuetral shampoo.
• Having untangled their hair at home, 3 hours prior coming to the site for observations, the first day of the study.

Exclusion Criteria

• Small, red bumps on the scalp, neck, and shoulders (bumps may become crusty and ooze).
• Subject having applied a product with an anti-hair fall claim (due to breakage)or anti dandruff claim in the 2 weeks preceding the start of the study.
• Having surgery history on the scalp (micro transplants …) 4.
• 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.
• 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 6.
• In the previous 15 days, Having applied a product with an anti hair loss claim (due to breakage) or anti dandruff claim.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Hair Fall, Reduction in Anti-dandruff effect	T0, 14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
Safety on skin	T0, 14 days and 28 days

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