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Patch Study, The objective of the study is to detect primary skin irritation potential and/ or existing allergic sensitization to the test substances.

Single application, double blinded, single centered, closed patch test to evaluate the safety of cosmetic formulations on healthy human subjects representing varied skin types.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005024
Enrollment
26
Registered
2014-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 1. Skin Gel - NGAA-082-014 2. Skin Gel - SCGGR#68077 3. Skin Gel - SCGPI#68078 4. Skin Gel - SCGPU#68079 5. Skin Gel - SCGPE#68080 6. Skin Gel - SCGYE#68095 7. TSP 90-18(A) 8. TSP 90-18

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Volunteer (female and/or male) in generally good health. 2. Volunteer between the ages of 18 and 50 years. 3. Volunteer has not participated in a similar clinical investigation in the past three months. 4. Volunteer willing to give a written informed consent, agrees for audio video consenting procedures and come for regular observation. 5. Volunteer with clear back.

Exclusion criteria

Exclusion criteria: 1. Known history or present condition of allergic response to any cosmetic products. 2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 3. Medications (e.g. steroids or antihistamines), which would compromise the study. 4. Known alcohol or drug abuse. 5. Pregnant or lactating women. 6. Any history of underlying uncontrolled medical illness including diabetes, liver disease or any other serious medical illness 7. Volunteers participating in any other cosmetics or any other clinical trial. 8. Hypersensitivity to any of the tested products.

Design outcomes

Primary

MeasureTime frame
Evaluation of Skin irritation potential (occurrence of Erythema, Oedema) w.r.t. the investigational products. Timepoint: For all the investigational products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal), Day 9 (1 week after patch removal).

Secondary

MeasureTime frame
N/ATimepoint: N/A

Countries

India

Contacts

Public ContactAditi Barve

Aim Research services pvt ltd

aditi@aimrspl.com02228908502

Outcome results

None listed

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