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Safety and Efficacy check of Cosmetic Product on skin

To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061433
Enrollment
36
Registered
2024-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Intervention1: Invisible sunscreen: Product will be applied on the whole face, once in a day for a period of 28 days Control Intervention1: NIl: NA

Sponsors

KAYA LIMITED
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 18 and 35 years of age. 4)Skin is healthy on the studied anatomic unit

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 a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic. 9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous 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. 13 Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. 14 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)

Design outcomes

Primary

MeasureTime frame
Reduction in total number of ComedonesTimepoint: Baseline,14days, 28days

Secondary

MeasureTime frame
NilTimepoint: NA

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