To check is the test product is causing irritation or allergy in men/women after repeated applications of patch.

Not Applicable

Completed

• Registration Number: CTRI/2023/04/051933
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 205

Inclusion Criteria

1. Voluntary healthy men and women between 18 and 65 years.

2. Photo type III to V.

3. Having apparently healthy skin on test area.

4. For whom the Investigator considers that the compliance will be correct.

5. Cooperating, informed of the need and duration of the examinations, and ready to comply

with protocol procedures.

6. Having signed a Consent Form.

7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the

course of the study.

8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:

exercise, sauna etc), during the course of the study.

9. Should be able to read and write (in English, Hindi or local language).

10. Having valid proof of identity and age.

Exclusion Criteria

1. Pregnancy (by UPT) and lactating women.

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

3. Dermatological infection/pathology on the level of studied area.

4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).

5. Any clinically significant systemic or cutaneous disease, which may interfere with study

procedures.

6. Chronic illness which may influence the outcome of the study.

7. Participants on any medical treatment either systemic or topical which may interfere with

the performance of the study (presently or in the past 1 month).

8. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of cutaneous tolerance by dermatological scoring (Draize scale for Induction scoring <br/ ><br>and ICDRG scale for Challenge scoring)Timepoint: Visit 1: ICD and inclusion/ exclusion. <br/ ><br>Induction Phase: Patch application on Visit 1 (V1, V3,V5, V7, V9, V11, V13, V15, V17). <br/ ><br>Patch will be removed on Visit 2 (V2, V4, V6, V8, V10, V12,V14, V16, V18). <br/ ><br>Patch area will be clinically examined, graded and scored on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) <br/ ><br>Challenge Phase: Patch application will be on naïve sites on the back on V20; <br/ ><br>patch will be removed at V21 (24 hours).Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours).

Secondary Outcome Measures

Name	Time	Method
oneTimepoint: None