To evaluate the in vivo safety and efficacy of a skin care formulation in terms of reduction in hyper pigmentation i.e. Acne PIH, improvement in skin even tone, skin brightness on healthy human subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness
Study Overview
Brief Summary
PRIMARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness on healthy female subjects for product coded:
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Chromametry, Mexametry, Digital Photographs
POPULATION:36 (26 females and 10 males) subjects will be selected for the study.
The subjects selected for this study will be healthy females, aged between 18 to 40 years, having normal skin type with visible Acne PIH, at least one spot of 3mm or more.
STUDY DURATION: 28 days following the first application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Indian female and male subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Subject having Normal skin type.
- •Subject having visible acne PIH with at least one spot of 3mm or more.
Exclusion Criteria
- •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 a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Outcomes
Primary Outcomes
Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness
Time Frame: Baseline, Day 14, Day28
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.