CTRI/2019/11/022065CompletedPhase 2
To Evaluate The Dermatological Safety Of The Investigational Products By Primary Irritation Patch Test On Healthy Human Volunteers With Sensitive Skin Type.
ITC LIMITED ITC Life Sciences and Technology CENTRE0 sites33 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Volunteer (female/ male) in generally good health.
- •2.Volunteer between the ages of 18 and 65 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 modified 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
- •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.
Investigators
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