Dermatological safety study on healthy Human Subjects.

Phase 2

Completed

• Registration Number: CTRI/2019/01/017039
• Lead Sponsor: Dabur India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1. Voluntary men and /or women.

2. Photo Type III and IV.

3. Having Apparently healthy skin on test area (upper arms)

4. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study

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

6. Cooperating, informed of the need and duration of the examinations [3 visits (more if necessary)] and ready to comply with protocol procedures.

7. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

8.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.

9. Willingness to avoid water contact (i.e.: swimming) or activity which causes excessive sweating (i.e.: exercise, saunaâ?¦), during the course of the study.

10. Ready to wear loose cotton clothes.

11. Should be able to read and write (in English, Hindi or Marathi).

12. Having valid proof of identity and age proof.

13. For Women only - A women who is NOT pregnant or NOT a nursing (Lactating) mother

Exclusion Criteria

1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out strenuous activities like excessive/brisk walking, exercising etc).

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

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

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

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.

9. For Women only, A women who is pregnant or is a nursing (Lactating) mother

10. For Women only, Positive results in UPT test

Study & Design

• Study Type: Interventional
• Study Design: Not specified