MedPath

Assessment of safety and effectiveness of product on human volunteers.

Not yet recruiting
Conditions
having dry skin on forearms
Registration Number
CTRI/2025/06/089686
Lead Sponsor
Bonji
Brief Summary

OBJECTIVE-The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation versus Untreated Control in terms of skin moisturization and skin water barrier function on healthy human subjects.**The evaluation will be performed using, Subject Self Evaluation (SSE), Dermatological Evaluation for Cosmetic Acceptability, Corneometry.**

POPULATION- 33 Female subjects will be selected for the study. The subjects selected for this study will be healthy females, aged between 18 and 40 years old, having dry skin on forearms.STUDY DURATION- 24 hours following the first application of the product.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
33
Inclusion Criteria

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

Exclusion Criteria
  • 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.
  • 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
NameTimeMethod
skin moisturization and skin water barrier functionBaseline, 30 Minutes, 24 Hours
Secondary Outcome Measures
NameTimeMethod

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

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