To evaluate the in vivo safety and efficacy of skin care formulations in terms of reduction in acne on healthy human subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Reduction in acne
Study Overview
Brief Summary
OBJECTIVE-The objective of this study will be to evaluate the in-vivo safety and efficacyof a skin care formulation in terms of reduction in acne on healthy human subjectsThe evaluation is performed using- Subject Self Evaluation(SSE) , Dermatological Evaluation:Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Images of whole face under Diffused Light
POPULATION-66 female & male subjects will be selected for the study. The study will beconducted in 2 groups and 33 subjects in each group.Group A - Product A
Group B - Product B
The subjects selected for this study are healthymale and female, aged between 18 and 30 years,presenting mild to moderateacne and oily to mixed oily skin type.
STUDY DURATION-14 days following the first use of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Indian Male and Female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Having mild to moderate acne.
- •5.Having mixed oily or oily skin type.
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 not signing the consent form and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •Being epileptic.
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Outcomes
Primary Outcomes
Reduction in acne
Time Frame: Baseline , Day 14
Secondary Outcomes
No secondary outcomes reported