To test the safety of test product by primary irritation patch test on Sensitive Ski

Phase 4

• Registration Number: CTRI/2023/05/053321
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Voluntary men and women ratio of 1:1 between 18 and 65 year

2.Having healthy skin on test area as assessed by

dermatological examination

3.For whom the investigator considers that the compliance will be correct

4. Subjects with normal, dry, oily and combination skin in approximately equal ratio.

5. Subjects cooperating informed of the need and duration of the examination and ready to comply

with protocol procedures.

6. Having a signed consent form.

7. Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.

8. Willingness to avoid excessive water contact (for example swimming) or activity which causes

excessive sweating (that is exercise, sauna ….), during the study.

9. Having valid proof of identity and age.

10. Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

Exclusion Criteria

1.Pregnant/nursing mothers.

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

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

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

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

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

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified