Safety test of cosmetic Product

Not yet recruiting

• Conditions: Normal skin

• Registration Number: CTRI/2023/10/058710
• Lead Sponsor: BARFANI HERBAL HAIR PRODUCTS

Brief Summary

Objective: The objective of this study is to evaluate the irritation potential on healthy human subjects  of Hair Care Formulations. 

Duration of study: 8 days study



Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) ,T1(Patch removal, Evaluation of test sites by Dermatologist ,T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)



Population: 26 healthy subjects (13 males + 13 females) .



The test area is checked for erythema and oedema caused due to the products and compared with positive control

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-20
• Last Update Posted: 2023-11-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Asian Indian male and female subjects 2) Healthy human 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 check-up) 3) Between 18 and 65 years of age 4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….).

Exclusion Criteria

• 1 For female: 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 Being diabetic. 5 Being asthmatic. 6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11 The day of the patch application: no cosmetic product must be used (test site clean with water only). Refusing to follow the restrictions below during the study:.
• For female: Do not become pregnant nor breastfeed.
• 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, and antihistamines, 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 12 Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area 13 Having disorder of the healing (whatever the considered area) • Having a rhinitis, allergic conjunctivitis, or rhino sinusitis 14 Having an allergy to perfumes and/or conservatives in cosmetic products 15 Having an allergy to plaster 16 Having a food allergy 17 Having a cardiovascular pathology (taking a beta blocker treatment) 18 Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 19 Taking a retinoid-based treatment by general or oral route 20 Taking specific treatment on the back. 21 Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 22 Having miliaria (prickly heat) on the back. 23 Presenting too many naevus on the back 24 Having high pilosity on the back. 25 Refusing to follow the restrictions below during the study:.
• During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
• Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal).
• Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches).
• Do not expose the back to the sun.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatological safety / Irritation potential on skin	Baseline,0 hrs,24 hrs and 7 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