To study the safety and possible allergenicity of chambers made by C.L.A.I.M.S Pvt Ltd using Human Repeat Insult Patch Test (HRIPT) technique in Men and Wome

Not Applicable

Completed

• Registration Number: CTRI/2012/04/002579
• Lead Sponsor: CLAIMS Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-07-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Voluntary men and women based on diagnostic patch test.

2.Between 18 and 65 years.

3.Phototype IV and lower (Phototype IV- Moderate brown skin which rarely burns and tans with ease. Phototype III (Lower) - White skin which sometimes burns, difficult to tan).

4.Having apparently healthy skin on studied 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 (sun or artificial UV) on test site, during the course of the study.

10.Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), 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. which will lead to excessive sweating).

2.Scars, hairs or tattoo on the studied area.

3.Pregnant women (as confirmed by UPT) and lactating women.

4.Hypersensitivity allergy antecedent to any cosmetic product in general or raw material by history.

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 participating in another similar cosmetic or therapeutic trial.

8.Volunteers with any skin condition that may cause interference with interpretation of the reactions or volunteers with past or present history of a photosensitive dermatosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Evaluation of cutaneous tolerance to the chambers by dermatological scoring.Timepoint: Diagnostic Patch Time points: 0hour and 48 hours. <br/ ><br> <br/ ><br>Induction Phase: <br/ ><br>0 hr, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432 hours. <br/ ><br> <br/ ><br>Resting Period of 10-15 days. <br/ ><br> <br/ ><br>Challenge phase: <br/ ><br>0 hours, 48 hours, 72 hours, 96 hours and 120 hours.

Secondary Outcome Measures

Name	Time	Method
noneTimepoint: none