Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types

Not Applicable

Completed

• Registration Number: CTRI/2022/03/040850
• Lead Sponsor: ITC LIMITED ITC Life Sciences and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

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

2. Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily, Normal, Dry and combination)

3. Subjects willing to come for regular follow up and ready to follow instructions during the study period

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 signing the consent form

3. Taking part in another study liable to interfere with this study

4. Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area

5. Having disorder of the healing

(whatever the considered area)

6. Having a rhinitis, allergic conjunctivitis or rhinosinusitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dermatological safety of <br/ ><br>investigational products <br/ ><br>Timepoint: Baseline, 1day, 2 days and 8day

Secondary Outcome Measures

Name	Time	Method
not applicableTimepoint: not applicable