To evaluate the safety and efficacy of skin care formulation in terms of reduction in pore appearance acne and reduction in sebum on healthy male and female subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Reduction in pore appearance acne and reduction in sebum
Study Overview
Brief Summary
OBJECTIVE· Primary Objective
The objective of this study is to evaluate the safety and efficacy of skin care formulation in terms of reduction in pore appearance acne and reduction in sebum on healthy male and female subjects.
· Secondary Objective
Secondary objective is to evaluate the in-vivo efficacy of a skin care formulation in terms of Reduction in acne lesion count, Acne Severity Index, acne size & redness on healthy male and female subjects.
The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry, Antera 3D, Digital Photographs
POPULATION36 (18 males & 18 females) will be selected for the study.
The subjects selected for this study will be healthy male & females, aged between 18 and 30 years, having mild to moderate acne, visible pores and oily to mixed oily skin type.
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 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Indian male & female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.having mild to moderate acne, visible pores and oily to mixed oily skin type.
Exclusion Criteria
- •1 For female:- Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Outcomes
Primary Outcomes
Reduction in pore appearance acne and reduction in sebum
Time Frame: Baseline, 30 minutes after application, Day 7, Day 14, Day 28
Secondary Outcomes
- Reduction in acne lesion count, Acne Severity Index, acne size & redness(Baseline, 30 minutes after application, Day 7, Day 14, Day 28)
Investigators
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.