Study to evaluate safety and effectiveness products on human volunteers

Not yet recruiting

• Conditions: having dry skin type

• Registration Number: CTRI/2025/03/081742
• Lead Sponsor: AU Naturel Beauty Pvt. Ltd (NEUDE)

Brief Summary

OBJECTIVE: The objective of this study will be to evaluateand compare the in-vivo safety and efficacy of Skin Care Formulation versesUntreated Control in terms of skin barrier function on healthy female subjectsfor products coded:

The evaluation is performed using: Subject Self Evaluation, DermatologicalEvaluation: Cosmetic Acceptability, Tewametry

POPULATION: 33 Female subjects will be selected for thestudy.

The subjects selected for this study are healthy females,aged between 18 and 40 years old, having dry skin type.

STUDY DURATION: 24 hours following the first application ofthe product.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-16
• Last Update Posted: 2025-05-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1)Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Subject having dry skin type.

Exclusion Criteria

• Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.
• Having refused to give her/his 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.
• 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) 10.
• Having cutaneous hypersensitivity.
• Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin barrier function	Baseline, 30 minutes after product application, 24 hours after product application

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Pooja Yadav

Principal investigator

02243349191

poojayadav@mascotspincontrol.in