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Safety & Efficacy check of cosmetic product

Primary Objective:To assess the efficacy of two skin care formulations, post routine sun exposure in terms of moisturization, skin radiance, skin brightening, improvement in even skin tone on healthy female subjects. Secondary Objective:To assess the efficacy of two skin care formulations, post routine sun exposure in terms of skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum on healthy female subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051906
Enrollment
72
Registered
2023-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

None listed

Interventions

Intervention1: Fairness Cream 1: Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days Intervention2: Fairness Cream 2: Product will be a

Sponsors

EMAMI LTD.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Indian female subjects 2 Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3 Between 18 and 35 years of age. 4 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 5 Having dull skin with dark spots (acne PIH) 6 Having under eye dark circle 7 Having dark to wheatish skin (L between 45 to 55) 8 Having oily to mixed oily skin type 9 Having daily routine involving atleast 2 hours sun exposure

Exclusion criteria

Exclusion criteria: 1 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 non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 6 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products. 7 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). 8 Having cutaneous hypersensitivity. 9 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 10 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11 Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 12 Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding. Do not take part in another study liable to interfere with this study. Do not take 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). Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, During the study: Do not use other cosmetic products than the tested products to the studied areas, The day of the measurements: No test product must be used (only face cleaned with water is accepted) 13 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 14 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 15 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements. 16 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months. 17 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) 18 Having had beauty treatment (e.g., skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study 19 Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 20 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 21 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 22 Refusing to follow the restrictions below during the

Design outcomes

Primary

MeasureTime frame
moisturization, skin radiance, skin brightening, improvement in even skin toneTimepoint: Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)

Secondary

MeasureTime frame
firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebumTimepoint: Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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