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Safety and efficacy assessment of Product on skin

Primary objective: To assess the in-vivo safety and efficacy of Skin care formulation in terms of reduction in Crow�s feet wrinkles, dark circles & improvement in skin moisturization & skin firmness in comparison with untreated area on healthy male & female subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045182
Enrollment
40
Registered
2022-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Serum: Product to be applied around the one eye(right or left) once at night and other eye is kept as untreated control. Product will be applied for 28 days. Control Intervention1: Untr

Sponsors

Kama Ayurveda Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Indian Male and 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 35 and 50 years of age. 4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria 5.Having mild to moderate crows feet wrinkles according to the Bazins atlas. [using Page n�° 40 & 41 of Skin Ageing Atlas (Scale: 0 to 6)]. 6.Having visible under eye dark circles. 7.Having under eye wrinkles of grade 2 to 4 according to the Basins atlas [ using Page n�° 46 and 47 under eye Wrinkles of Skin Ageing Atlas (Scale 0 to 8)] 8.Having visible Fine lines.

Exclusion criteria

Exclusion criteria: 1 For Females: 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 a progressive asthma. 6 Being epileptic. 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Having cutaneous hypersensitivity 9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10 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) 11 Having consumed caffeine-based products (coffee, cola, tea â�¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements 12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14 Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted) 15 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. Do not have acne prone skin. 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) 16 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 17 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 18 Having consumed caffeine-based products (coffee, cola, tea, â�¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 19 Having taken a medicinal treatment which could lead to hyper pigmentation (phenyto�¯n, amiodarone, metals, minocyclineâ�¦) in the previous 6 months 20 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneâ�¦) 21 Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â�¦) or having applied self-tanning products in the week preceding the start of the study 22 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 23 Ha

Design outcomes

Primary

MeasureTime frame
Safety, Reduction in Crow�s feet wrinkles, dark circles & improvement in skin moisturization & skin firmnessTimepoint: Baseline, Day 1, day 3 and Day 28

Secondary

MeasureTime frame
NilTimepoint: NIl

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