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Primary Irritation Patch Testing on Adult Healthy Human Subjects with Sensitive Skin. (Single 24-Hour Application)

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of sensitive skin type.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/046975
Enrollment
40
Registered
2022-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Skin Leave-On: Neat, 0.04 ml, single dose, topical application for 24 hrs Intervention2: Skin Leave-On: Neat, 0.04 ml, single dose, topical application for 24 hrs Intervention3: Shower

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects with Fitzpatrick skin type III to V 2) Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females). 3) Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire. 4) Subjects identified to have sensitive skin on the basis of Dermatological assessment of skin with fine texture and closeness of blood vessels to the surface.

Exclusion criteria

Exclusion criteria: 1) Subjects who are pregnant or nursing (as confirmed by Urine Pregnancy Test for the determination of Pregnancy). 2) Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study. 3) Subjects with cutaneous disease, chronic illness or self-reported Immunological disorders or any other illness including Diabetes, liver disease, HIV or any other serious medical illness. 4) Subject suffering from any active clinically significant skin diseases which may contraindicate. 5) Subjects with known allergy or sensitization to medical adhesives, bandages or a present condition of allergic response to any cosmetic product.

Design outcomes

Primary

MeasureTime frame
Irritation Potential of test productsTimepoint: 24 hours post patch removal (Day 03)—

Secondary

MeasureTime frame
Irritation Potential of test productsTimepoint: 30 minutes post patch removal (Day 02) and 168 hours post patch removal (Day 09);Irritation potential of the test products by Subject Self-assessment (Irritation)Timepoint: Day 01, Day 02, Day 03 & Day 09;Safety by asking well-being of subject and Adverse Event assessmentTimepoint: Day 02, Day 03 & Day 09—

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026