Evaluation of the irritation potential of Skin and Hair Care Formulations on healthy human subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety assessment of products
Study Overview
Brief Summary
Single Application Semi occlusive, Closed Patch test is conducted to measure the irritation potential of cosmetic products on the skin
Objective: 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)
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 24 healthy subjects (12 males + 12 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
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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 checkup) 2) Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
Exclusion Criteria
- •For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.
Outcomes
Primary Outcomes
Safety assessment of products
Time Frame: Baseline,0 hrs,24 hrs&7 days
Secondary Outcomes
- Not Applicable(Not Applicable)