Safety evaluation of test products by PIPT on all healthy human with all skin types

Phase 4

Completed

• Registration Number: CTRI/2023/03/050690
• Lead Sponsor: Emami Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Phase I; Voluntary men and women ratio of 1:1 between 18 and 65 years.

â?? Phase II; Voluntary boy and girl ratio of 1:1 between 12 and 17 years.

â?? Having healthy skin on test area as assessed by dermatological examination.

â?? For whom the investigator considers that the compliance will be correct.

â?? Subjects with normal, dry, oily and combination skin

Exclusion Criteria

Pregnant/nursing mothers.

â?? Scars, excessive terminal hair, or tattoo on the studied area.

â?? Dermatological infection/pathology on level of studied area.

â?? Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)

â?? Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or

procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of subjects that showed No significant irritation. <br/ ><br> Score of less than or equal to 2 on the Draize scale.Timepoint: Baseline, Visit 2,Visit 3, Visit 4, Visit 5

Secondary Outcome Measures

Name	Time	Method
ATimepoint: NA