To evaluate and compare the in-vivo safety and efficacy of the skin care formulations in terms of reduction in Acne (live/occurring) on healthy female subjects
Overview
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Cureskin
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Reduction in Acne
Overview
Brief Summary
The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of the skin care formulations in terms of reduction in Acne (live/occurring) on healthy female subjects.
Products: Regime1 and Regime 2
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological : Cosmetic Acceptability, Dermatological Evaluation: Efficacy
The study lasts 28 days following the first application of the regime on whole face.
POPULATION - 72 Females subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 30 years, having mild to moderate acne and oily to mixed oily skin type.
The study will be conducted in 2 groups.
I. Group A: This group will include 36 female subjects using Regime 1.
II. Group B: This group will include 36 female subjects using Regime 2.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Indian female subjects
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4 Having mild to moderate acne and oily to mixed oily skin type.
Exclusion Criteria
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/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 a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •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 (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
Outcomes
Primary Outcomes
Reduction in Acne
Time Frame: Baseline, Day 14, Day 28
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.