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Efficacy check of skin care product

To evaluate and compare the safety and efficacy of skin care formulation in terms of moisturization and Skin Barrier Function (trans epidermal water loss) versus untreated control on healthy human subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060868
Enrollment
33
Registered
2023-12-28
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: Moisturizer: Application to be carried out on the 2 randomized sites one for test product and one randomized site will serve as untreated control site. Application is carried out once f

Sponsors

SATIYA NUTRACEUTICALS PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 2)Subject having dry skin with corneometer reading less than 30 on forearms

Exclusion criteria

Exclusion criteria: 1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.Having refused to give her assent by signing the consent form. 2)Taking part in another study liable to interfere with this study. 3)Being known diabetic case 4)Known asthma case 5)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 6)Being known thyroid case 7)Being epileptic. 8)Following a chronic medicinal treatment comprising any of the following product: aspirin-based product, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 9)Known case of hypersensitivity. 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic product. 11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12)Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. 13)Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study.

Design outcomes

Primary

MeasureTime frame
Moisturization and Skin Barrier Function (trans epidermal water loss)Timepoint: Baseline, 2 hours, 24 hours, 48 hours, 100 hours

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