Evaluation of irritation potential of Anti-Frizz Shampoo through dermatological evaluation by single occlusive patch test on healthy adult human volunteers

Cholayil Private Limited1 site in 1 country24 target enrollmentStarted: March 31, 2026Last updated: March 18, 2026

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: Cholayil Private Limited
Enrollment: 24
Locations: 1
Primary Endpoint: 1. Erythema, dryness, wrinkles Oedema

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Inclusion Criteria:

Healthy volunteers with clear skin (no eczema, wounds, or scars) on the studied area.
Age 18-55, with 12 male and 12 female volunteers.
Full compliance with study procedures.

Exclusion Criteria:

Pregnant or lactating women.
Volunteers with any skin disorders.
Use of any topical agents on the application site within the past 30 days.

Methodology

The study will involve 24 healthy adult volunteers (12 males and 12 females) aged 18-55 years, selected according to protocol guidelines. The procedure includes applying a patch containing Finn’s chamber on the back or shoulder area of the volunteers. Each chamber will hold 25 microlitres of the test product and one positive control. The patch will remain in contact with the skin for 24 hours. If any allergic reactions occur, the patch can be removed within 24 hours, and the investigator will be notified immediately. All procedures will be conducted as per the study protocol.

Examination Schedule Overview:

Screening: Registration, consent, health check, and dermatologist approval.

T0 (Pre-application): Acclimatization, patch application, AE/SAE monitoring.

T1 (0 hrs post-patch removal): Acclimatization, patch removal, AE/SAE monitoring.

T2 (24 hrs post-patch removal): Acclimatization, dermatological evaluation, AE/SAE monitoring.

T8 (1 week post-patch removal): Acclimatization, final dermatological evaluation, AE/SAE monitoring, and review of positive cases.

Study Design

Study Type: Interventional
Allocation: Na
Masking: None

Eligibility Criteria

Ages: 18.00 Year(s) to 55.00 Year(s) (—)
Sex: All

Inclusion Criteria

•1.Healthy participants with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) 2.Age group of 18 to 55 years, 12 male and 12 female participants.
•3.Compliance with the study procedures involved.

Exclusion Criteria

•1.Pregnant and lactating women 2.Participants with any other skin disorders.
•3.Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.