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Study to Check Safety of Skin Care Products on humans

To evaluate the in vivo safety of skin care formulation on perimenopausal and menopausal female subjects. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095325
Enrollment
33
Registered
2025-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

None listed

Interventions

Intervention1: Test Product: The product is applied on whole face, twice in a day for the period of 7 days. Control Intervention1: Nil: NA

Sponsors

Sirona Hygiene Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Female Asian Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Perimenopausal and menopausal females.

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 his/her assent by not signing the consent form and Informed consent form 3. Taking part in another study liable to interfere with this study 4. Being known diabetic case 5. Known asthma case 6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7. Being known thyroid case 8. Being epileptic. 9. 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 or corticosteroid by any route (the only medication permitted is paracetamol) 10. Known case of hypersensitivity. 11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

Design outcomes

Primary

MeasureTime frame
The product is safe for the skin by assessing possible reactions such as erythema, oedema, dryness, scaling, peeling, itching, and tingling.Timepoint: Baseline, day 3, day 7

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: Feb 4, 2026