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Study to check the safety and efficacy of cosmetic product on human volunteers

To evaluate and compare the in vivo safety and efficacy of a skin care formulation versus placebo formulation in terms of reduction in under eye dark circles on healthy human subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110181
Enrollment
30
Registered
2026-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Under Eye Cream: Product is applied around the eyes (Left eye area) for twice a day for the period of 28 days Intervention2: Placebo: Product is applied around the eyes (right eye area)

Sponsors

Alvio Pharmaceuticals Pvt Ltd/ UNCAP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Indian male and female subjects 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) Between 35 and 55 years of age. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar .) Having mild to moderate dark circles and visible wrinkles

Exclusion criteria

Exclusion criteria: For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. Having refused to give her assent by not signing the consent form. Taking part in another study liable to interfere with this study. Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months). Having a progressive asthma. Being epileptic. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months). Having cutaneous hypersensitivity. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 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). Having consumed caffeine-based products (coffee, cola, tea ), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 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)

Design outcomes

Primary

MeasureTime frame
Reduction in under eye dark circlesTimepoint: Baseline, Day 14, Day 28

Secondary

MeasureTime frame
NILTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

niharika@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026