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Safety and efficacy assessment of Product on skin

To evaluate the in-vivo safety & efficacy of a Skin Care regime in terms improvement in skin brightening, skin hydration, skin smoothness, skin pH balance and skin water barrier function on healthy female subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063536
Enrollment
60
Registered
2024-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

None listed

Interventions

Intervention1: Cream Cleanser: Product is applied on whole face , twice in a day for the period of 14 days. Control Intervention1: Nil: NA

Sponsors

DPKA Universal Consumer Ventures Private. Limited.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Indian / Asian female subjects 2) Healthy subjects 3) Having dull skin & having wheatish to dark skin. 4) 15 normal skin volunteers,35 dry skin volunteers 5) 10 sensitive skin. (declared through lactic acid sting test)

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 signing the consent form 3.Taking part in another study liable to interfere with this study 4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6.Having a progressive asthma (either under treatment or last fit in the last 2 years) 7.Being epileptic 8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9.Having cutaneous hypersensitivity 10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 11.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) 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

Design outcomes

Primary

MeasureTime frame
Improvement in skin brightening, skin hydration, skin smoothness, skin pH balance and skin water barrier functionTimepoint: Baseline, 30 minutes, 2 hour, 4 hour, 7 days, 14 days—

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