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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 209

Inclusion Criteria

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

skin as determined by lactic acid sting test.

2. Fitzpatrick skin type III to V.

3. Having apparently healthy skin on test area.

4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application

areas during the course of the trial.

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. Ready to wear loose cotton clothes.

11. Having valid proof of identity and age.

12. Subject having not participated in another similar cosmetic or therapeutic trial in the past

one month.

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/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/ 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

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