Dermatological Safety Study on Healthy Human Subjects
- Registration Number
- CTRI/2016/08/007194
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
1.Both Female and male subjects in age group between 18 and 50 years (both the ages inclusive).
2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3.Skin is healthy on the studied anatomic unit i.e. back of subject (free of eczema, wounds, inflammatory scarâ?¦.)
1.For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2.Subject not willing to give voluntary Consent.
3.Taking part in another study liable to interfere with this study
4.Any history of underlying uncontrolled medical illness including diabetes, Asthma, Liver disease or any other serious medical illness.
5.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
6.Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
8.Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
9.Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area
10.Having disorder of the healing (whatever the considered area)
11.Having a rhinitis, allergic conjunctivitis or rhino sinusitis
12.Having an allergy to perfumes and/or conservatives in cosmetic products
13.Having an allergy to plaster
14.Having a food allergy
15.Having a cardiovascular pathology (taking a beta blocker treatment)
16.Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
17.Taking a retinoid based treatment by general or oral route
18.Taking specific treatment on the back
19.Having miliaria (prickly heat) on the back.
20.Presenting too many naevus on the back
21.Having high pilosity on the back
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects.Timepoint: 0 hr, 24 hr, 8 days (Post 1 week after 0 hours of patch removal)
- Secondary Outcome Measures
Name Time Method Overall safety of SubjectsTimepoint: 0 hr, 24 hr, 8 days (Post 1 week after 0 hours of patch removal)