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To check irritation potential of the given samples- Patch test

Single application closed patch test to evaluate the safety of test formulations on healthy human subjects . - PIPT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003321
Enrollment
24
Registered
2013-01-23
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. Anne French Tender Care- with Wheat germ oil and Aloe cucumber perfume: Day 1: (patch application, Removal and o hour observation), Day 2 (24 hrs.observation after Patch Removal),Da

Sponsors

Wyeth Consumer Healthcare
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Is a female in generally good health,Is between the ages of 14 and 18 years,Has not participated in a similar clinical investigation in the past four weeks,Is willing to give a written informed consent and come for regular observation.

Exclusion criteria

Exclusion criteria: A known history or present condition of allergic response to any cosmetic products,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,Medications (e.g. steroids or antihistamines), which would compromise the study.

Design outcomes

Primary

MeasureTime frame
Irritation potentialTimepoint: On each subjectâ??s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs.

Secondary

MeasureTime frame
Investigational products to be tested for irritancy testTimepoint: On each subjectâ??s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs

Countries

India

Contacts

Public ContactMs Meghana Surve

KETs Scientific Research Centre.

meghana@kelkarcosmetology.com02225639644

Outcome results

None listed

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