To study the safety of test products on skin in humans.

Completed

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

• Registration Number: CTRI/2023/02/049702
• Lead Sponsor: Dabur India Limited

Brief Summary

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Patch 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.



Results:

The study was completed and No adverse events were reported during the study.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-02-25
• Last Update Posted: 2024-01-18
• Study Start: 2024-05-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Voluntary men and women (preferably equal number of males and females) between 18 and 65 years.
• Participants representing normal, oily, dry and combination skin type in approximately equal ratio.
• Fitzpatrick skin type III to IV.
• Having apparently healthy skin on test area.
• Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial 6.
• Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
• Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
• Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
• Should be able to read and write (in English, Hindi, or local language).
• Ready to wear loose cotton clothes 12.
• Having valid proof of identity and age.
• Subject having not participated in another trial in the past one month.

Exclusion Criteria

• Pregnancy (by history) and lactating women.
• Scars, excessive terminal hair, or tattoo on the studied area.
• A participant who the Investigator feels will not be compliant with trial requirements 4.
• Dermatological infection/pathology on the level of studied area.
• Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
• Any clinically significant systemic or cutaneous disease, which may interfere with trial procedures.
• Chronic illness which may influence the outcome of the trial.
• Participants on any medical treatment either systemic or topical which may interfere with the performance of the trial (presently or in the past 1 month).
• 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.	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