To evaluate the irritation potential on healthy human subjects of Skin Care Formulations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Dermatological safety of test products, Irritation potential of test products
Study Overview
Brief Summary
Objective: The objective of this study is to evaluate the irritation potential on healthy human subjects of Skin Care Formulations.
Duration of study: 8 days study
Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) ,T1(Patch removal, Evaluation of test sites by Dermatologist ,T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population: 26 healthy subjects (13 males + 13 females).
The test area is checked for erythema and oedema caused due to the products and compared with positive control
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Asian Indian male and female subjects 2) Healthy human 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 check-up) 3) Between 18 and 65 years of age 4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….).
Exclusion Criteria
- •1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give his/her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being diabetic.
- •5 Being asthmatic.
- •6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
Outcomes
Primary Outcomes
Dermatological safety of test products, Irritation potential of test products
Time Frame: Baseline,0 hrs,24 hrs and 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.