The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Sensitization potential
Study Overview
Brief Summary
The objective of this study will be to evaluate the sensitization potential of Skin Care Formulations on healthy human subjects
The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method
Total duration of the study: 40 days following the first application of product.
Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25)
**The study is conducted in 3 phases: 1.****Induction Phase, 2.****Resting Phase,3.**Challenge Phase
Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours
Number of volunteers: 220 (110 male+110 female) subjects
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit.
Exclusion Criteria
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give his or her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being diabetic.
- •Being asthmatic.
- •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).
- •Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
Outcomes
Primary Outcomes
Sensitization potential
Time Frame: Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.