Evaluation of the safety of 1 test product for phototoxicity, using a photo patch test technique

Not Applicable

Completed

• Registration Number: CTRI/2011/06/001778
• Lead Sponsor: AMRA Remedies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-06-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Voluntary men and/or women.

2. Between 18 and 65 years.

3. Photo type III and IV.

4. Having apparently healthy skin on test area.

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

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

7. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.

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

9. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study except as required for study protocol.

10. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna?), during the course of the study.

11. Ready to wear loose cotton clothes.

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 activities like excessive/brisk walking, exercising etc).

2. Pregnant women and lactating women.

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, UV light or sunlight).

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

6. 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).

7. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.Timepoint: 48 hours

Secondary Outcome Measures

Name	Time	Method
oneTimepoint: None