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Safety and efficacy of Skin care formulation

PRIMARY OBJECTIVE: To evaluate the in-vivo efficacy and safety of a skin care formulation 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 healthy male & female subjects. SECONDARY OBJECTIVE: To evaluate the in-vivo efficacy of 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042231
Enrollment
36
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: EMC Face Cream: Product A: Application will be done on whole facer, twice a day, in morning and at night for the period of 28 days. Control Intervention1: NIL: NIL

Sponsors

Kama Ayurveda Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
improvement in hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness & elasticity, reduction in pore size, reduction in sebum contentTimepoint: BASELINE, 10 minute after Product application, 28 days—

Secondary

MeasureTime frame
reduction in transepidermal water loss, balancing skin pH and improvement in skin plumpnessTimepoint: BASELINE, 10 minute after Product application, 28 days—

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026