Study to check the effectiveness of product on human volunteers

Not yet recruiting

• Conditions: with dull skin and having outdoor activity on daily basis and residing in polluted area

• Registration Number: CTRI/2025/06/088087
• Lead Sponsor: Honasa Consumer Pvt. Ltd.

Brief Summary

OBJECTIVE - The objective of this study is to evaluate & compare the in-vivo safety and anti-pollution effect of skin care formulation in terms of improvement in Skin Brightness, Skin Even Tone, Skin Moisturization, Skin Water Barrier Function, Skin Smoothness and reduction in Sebum Content of Skin on healthy human subjects.The evaluation is performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry, Tewametry, Sebumetry

POPULATION - 72 female subjects will be selected for the study. The study will be conducted in 2 groups.

I.       Group A - This group will include 36 female subjects using Product A.

II.     Group B - This group will include 36 female subjects using Product B.

The subjects selected for this study will be healthy females, aged between 18 and 45 years, with dull skin and having outdoor activity on daily basis and residing in polluted area.

STUDY DURATION - 28 days following the first application of the product.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-06
• Study Start: 2025-06-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• 1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic 4.Having dull skin.
• 5.Having outdoor activity on daily basis 6.Residing in polluted area.

Exclusion Criteria

• Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
• 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.
• 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.
• Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
• Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Skin Brightness, Skin Even Tone, Skin Moisturization, Skin Water Barrier Function, Skin Smoothness and reduction in Sebum Content	Baseline,3 hours post-sun exposure after the first application, Day 28

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