The Study to assess safety and effectiveness of product on human volunteers

Not yet recruiting

Conditions: presenting mild to moderate acne and oily to mixed oily skin type

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.

Recruitment & Eligibility

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 3.
Taking part in another study liable to interfere with this study 4.
Being known diabetic case 5.
Known asthma case 6.
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7.
Being known thyroid case 8.
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) 10.
Known case of hypersensitivity.
Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

Primary Outcome Measures

Name	Time	Method
Reduction in acne	Baseline , Day 14

Secondary Outcome Measures

Name	Time	Method

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Pooja Yadav
Principal investigator
02243349191
poojayadav@mascotspincontrol.in