To know the safety of Investigational products by assessing the irritation after patch application onhealthy human volunteers

Not Applicable

Completed

• Registration Number: CTRI/2018/05/013745
• 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: 2018-05-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

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

Subjects representing varied skin types (ideally equal representationof all 4 skin types ââ?¬â?? Oily, Normal, Dry and combination)Subjects willing to come for regular follow up and ready to followinstructions during the study period

Exclusion Criteria

For female : Being pregnant or breastfeeding or having stopped tobreastfeed in the past three months, Having refused to give his/herassent by signing the consent form,Taking part in another studyliable 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, allergicconjunctivitis or rhinosinusitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of <br/ ><br>investigational products by primary irritation <br/ ><br>patch test on healthy human volunteers of varied <br/ ><br>skin types <br/ ><br>Timepoint: T0,T1,T2,T8

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable