To evaluate the in vivo efficacy and safety of a skin care regime in terms of reduction in acne postinflammatory hyperpigmentation, improvement in skin even tone, skin brightness, hydration, Skin elasticity and skin gloss on healthy male subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, hydration, Skin elasticity and skin gloss
Study Overview
Brief Summary
OBJECTIVE:To evaluate the in-vivo efficacy and safety of a skin care regime in terms of reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, hydration, Skin elasticity and skin gloss on healthy male subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation Safety, Mexametry, Chromametry, Corneometry, Glossymeter, Cutometry
POPULATION: 72 (36 for test regime and 36 for placebo regime) male subjects will be selected for the study.
The subjects selected for this study are healthy males, aged between 18 and 40 years old,
STUDY DURATION: 28 days following the first application of the test product.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Indian male subjects.
- •Healthy subjects.
- •Skin is healthy on the studied anatomic unit 4)Having normal skin type with visible Acne PIH.
Exclusion Criteria
- •Having refused to give his assent by not signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having progressive asthma.
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
- •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 consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
Outcomes
Primary Outcomes
Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, hydration, Skin elasticity and skin gloss
Time Frame: Baseline, Day 7, Day 14, Day 28
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.