Evaluation of safety of products

Not Applicable

Completed

• Registration Number: CTRI/2023/11/059460
• Lead Sponsor: ITC LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-16
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1)Female and male Asian Indian subjects.

2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)

3)Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).

4)For females: Urine pregnancy test (UPT) need to done.

Exclusion Criteria

1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.

2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.

3)Having healing disorder in the concerned area.

4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis.

5) Having an allergy to perfumes and/or preservatives in cosmetic products.

6)Having an allergy to plaster / adhesives used in plaster.

7) Having a food allergy.

8)Having a cardiovascular pathology that requires beta blocking treatments.

9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.

10)Taking a retinoid-based treatment by general or oral route.

11)Taking specific treatment on the back.

12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.

13)Having miliaria (prickly heat) on the back.

14) Presenting too many neavi on the back.

15) Having high pilosity on the back.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs & 7 days

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: NA