To study the irritant and allergic potential of test products in Men and Women.

Not Applicable

• Registration Number: CTRI/2024/02/062215
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Voluntary men and or women between 18 and 65 years with 50 participants having

sensitive skin as determined by lactic acid sting test.

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. Willing to give written informed consent to participate in the trial after informing all

information concerning the trial procedures and trial objectives.

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

course of the trial.

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

exercise, sauna...), during the course of the trial.

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. A participant who the Investigator feels will not be compliant with trial requirements.

4. Dermatological infection or pathology on the level of studied area.

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

6. Any clinically significant systemic or cutaneous disease, which may interfere with trial

procedures.

7. Chronic illness which may influence the outcome of the trial.

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

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

9. 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.Timepoint: Visit 1: ICD and inclusion or 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