Safety and efficacy of Skin care formulation

Not yet recruiting

Brief Summary: Objective:

PRIMARYOBJECTIVE To evaluate the in-vivo efficacy and safety of a skin careformulation in terms of improvement in hydration, reduction in acne,improvement in skin texture (i.e., softness & smoothness), skin firmness& elasticity, reduction in pore size, reduction in sebum content on healthymale & female subjects. â€¢ SECONDARY OBJECTIVE To evaluate the in-vivo efficacyof a skin care formulation in terms of reduction in transepidermal water loss,balancing skin pH and improvement in skin plumpness on healthy male &female subjects.

Durationof study: 28 days study

Kinetics:Screening, T0, T+10 minutes after Product application and T+28 days

Population:36 (18 Females & 18 Males) volunteers

Theevaluation is performed using:

1     Subjectâ€™s Self Evaluation

2     Dermatological Evaluation: Cosmetic Acceptability

3     Dermatological Evaluation: Efficacy

4     Corneometry

5     Cutometry

6     Sebumetry

7     Tewametry

8     Skin pH metry

9     Illustrative Images of the whole & 3/4th faceunder diffuse light

Recruitment & Eligibility

Inclusion Criteria

1)Indian male and female subjects 2)Healthy subjects 3)Between 18 and 45 years of age.
4)Skin is healthy on the studied anatomic unit 5)Having oily & mixed oily skin and combination skin type with acne lesions, blackhead, whiteheads & visible pores.

Exclusion Criteria

1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having refused to give his/her assent by signing the consent form 3)Taking part in another study liable to interfere with this study 4)In the 6 previous months Having started, changed or stopped a hormonal treatment, Having taken an oral retinoid-based treatment.
5)In the previous month Having undergone a physical or chemical treatment for acne, Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment, Having had an oral treatment with a base of cimetidine, zinc or spironolactone 6)In the 2 previous weeks Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin, Having had oral or local antibiotic treatment for acne, Having had beauty treatment, Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 7)Refusing to follow the restrictions below during the study Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin , Do not have beauty treatment, Do not start, change or stop a hormonal treatment, Do not start a local or general treatment acting on seborrhoea, Do not expose himself/herself to the sun, Strictly avoid sun exposure.

Primary Outcome Measures

Name	Time	Method
improvement in	BASELINE, 10 minute after Product application, 28 days
hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness	BASELINE, 10 minute after Product application, 28 days
& elasticity, reduction in pore size, reduction in sebum content	BASELINE, 10 minute after Product application, 28 days

Secondary Outcome Measures

Name	Time	Method
reduction in transepidermal water	loss, balancing skin pH and improvement in skin plumpness

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raji Patil
Principal investigator
02243349191
raji@mascotspincontrol.in