To study safety of test products in Human beings

Completed

• Conditions: Healthy Human volunteers with healthy skin will be included in the study.

• Registration Number: CTRI/2023/10/058626
• Lead Sponsor: Dabur Research and Development Centre.

Brief Summary

atch test - This test is performed to assess the dermal safety of test products involved in the

trial. It is a technique used to determine the potential of specific substances to cause irritancy

of the skin. Irritants are substances that damage the skin by direct toxic action. The damage

will depend upon the nature of the irritant, its concentration, and duration of exposure.



Irritation is manifested as inflammatory responses such as erythema (redness), oedema

(swelling), vesiculation and finally to an intense suppurative reaction without the involvement

of immune system.

In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed

under a constant artificial daylight source and the marked site is scored post 24 hours after the

removal of the patches. Reactions such as erythema, dryness and wrinkling are then scored using Draize scale.



Result: The study was completed and there were no adverse events that occured during the course of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Study Completion: 2023-11-24
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• a) Voluntary men and women (preferably equal number of males and females) between 18 and 65 years having sensitive skin in nasolabial area as determined by lactic acid sting test.
• b) Fitzpatrick skin type III to IV.
• c) Having apparently healthy skin on test area.
• d) Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial.
• e) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
• f) Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
• g) Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
• h) Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the trial.

Exclusion Criteria

• a) Pregnancy (by UPT) and lactating women.
• b) Scars, excessive terminal hair, tattoo, cuts, wounds, irritation symptoms, abrasion, or any other skin condition on the studied area.
• c) Athletes and subjects with history of excessive sweating.
• d) Subjects on oral corticosteroid.
• e) Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV, or any other serious medical illness.
• f) A participant who the Investigator feels will not be compliant with trial requirements g) Dermatological infection/pathology on the level of studied area.
• h) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
• i) Any clinically significant systemic or cutaneous disease, which may interfere with trial procedures.
• j) Chronic illness which may influence the outcome of the trial.
• l) 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 of skin reactions.	48 hours.

Trial Locations

Locations (1)

C.L.A.I.M.S. Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

C.L.A.I.M.S. Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Rajiv Joshi

Principal investigator

rsjdrs@gmail.com