To check irritation potential of the given samples

Single application closed patch test to evaluate the safety of skin and hair care formulations on healthy human subjects representing varied skin type.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/003006

Enrollment

Registered

2012-09-18

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: 1.(experimental): Vivel Deodrant Aerosol Spray (B.No.60114): 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

Eligibility

Inclusion criteria

Inclusion criteria: Is a female/ male in generally good health,Is between the ages of 18 and 50 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

Measure	Time frame
irritation potentialTimepoint: On each subjectÃ¢â?¬â?¢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).	—

Measure

Time frame

irritation potentialTimepoint: On each subjectÃ¢â?¬â?¢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).

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Secondary

Measure	Time frame
Investigational products to be tested for irritancy testTimepoint: On each subjectÃ¢â?¬â?¢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).	—

Measure

Time frame

Investigational products to be tested for irritancy testTimepoint: On each subjectÃ¢â?¬â?¢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).

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Countries

India

Contacts

Public ContactMs Avani Rane

KETs Scientific Research Centre

avani@kelkarcosmetology.com02225639644

Outcome results