To check irritation potential of the given samples (Patch test)

Phase 2

Completed

Brief Summary: Skin Irritation Test:

Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test.

Recruitment & Eligibility

Inclusion Criteria

1.Volunteer (female/ male) in generally good health.
2.Volunteer between the ages of 18 and 65 years.
Volunteer has not participated in a similar clinical investigation in the past four weeks.
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 modified Dr. Baumannâ€™s sensitive skin Questionnaire.
6.Subject identified to have sensitive skin on basis of Dermatologistâ€™s assessment of skin with fine texture and closeness of blood vessels to the surface.

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.
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.

Primary Outcome Measures

Name	Time	Method
Irritation potential	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 Outcome Measures

Name	Time	Method
investigational products to be tested for irritancy test	On each subjectâ€™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).

Locations (1): The KETs Scientific Research Centre
🇮🇳
(Suburban), MAHARASHTRA, India
The KETs Scientific Research Centre
🇮🇳(Suburban), MAHARASHTRA, India
Ms Meghana Surve
Principal investigator
02225639644
meghana@kelkarcosmetology.com