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To check irritation potential of the given samples- Patch test

SINGLE APPLICATION CLOSED PATCH TEST TO EVALUATE THE SAFETY OF SKIN CARE FORMULATIONS ON HEALTHY HUMAN SUBJECTS WITH SENSITIVE SKIN. - PIPT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/06/003738
Enrollment
35
Registered
2013-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Cleansing Solution-CW39112-1: 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) and Day 9 (1 week aft

Sponsors

ITC Limited Peenya Industrial Area Peenya Bangalore Tel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Volunteer (female/ 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 four weeks. 4. Volunteer willing to give a written informed consent and come for regular observation. 5.Subjects scoring greater than 30 for Section 2- Sensitive Vs Resistant skin in Dr. Baumannââ?¬•s sensitive skin Questionnaire. 6.Subject identified to have sensitive skin on basis of Dermatologistââ?¬•s assessment of skin with fine texture and closeness of blood vessels to the surface.

Exclusion criteria

Exclusion criteria: 1.A 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. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study. 4.Pregnant or lactating females. 5.Subjects participating in any other cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
irritation potential Timepoint: first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal.

Secondary

MeasureTime frame
Investigational products to be tested for irritancy testTimepoint: On each subject�s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the 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) and Day 9 (1 week after patch removal).

Countries

India

Contacts

Public ContactMsMayuri Jaitpal

KETs Scientific Research Centre

mayuri@kelkarcosmetology.com02225639644

Outcome results

None listed

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