Evaluation of the Skin Irritation and Skin Sensitization Potential by Human Repeat Insult Patch Test (HRIPT).

Not Applicable

Completed

Registration Number: CTRI/2024/02/063099

Lead Sponsor: Himalaya Wellness Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

1.Age: 18-65 years (both inclusive) at the time of consent.

2.Sex: Males and non-pregnant/non-lactating females.

3.Subjects having Phototype III to V

4.Subjects having apparently healthy skin on test area

5.Subjects for whom the investigator considers that the compliance will be correct.

Exclusion Criteria

1.Subject who is pregnant or lactating.

2.Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) that can interfere with the reading.

3.Subjects with dermatological infection/pathology on the level of studied area.

4.Subjects with hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).

5.Subjects with any clinically significant systemic or cutaneous disease, which may interfere with study procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the test products for their skin irritation and skin sensitization potential by repetitive applications on the skin of human subjects.Timepoint: Diagnostic Patch Time points: 0hour and 48 hours. <br/ ><br> <br/ ><br>Induction Phase: 0 hr, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432 hours. <br/ ><br> <br/ ><br>Resting Period of 14 days. <br/ ><br> <br/ ><br>Challenge phase: 24 hours, 48 hours and 72 hours.

Secondary Outcome Measures