Clinical study to assess the effectiveness of product on human volunteers
- Conditions
- complaining flaccid breast, with BMI-25-35kg/m2.
- Registration Number
- CTRI/2025/03/082217
- Lead Sponsor
- VLCC Personal Care Ltd.
- Brief Summary
OBJECTIVE: The objective of this study will be to evaluatethe in- vivo efficacy and safety of a breast line firming formulation in termsof improvement in breast firmness, breast shape & breast upliftment onhealthy female subjects.
The evaluation is performed using: Subject Self Evaluation, DermatologicalEvaluation: Cosmetic Acceptability, Expert assessment, Anthropometricmeasurements, Cutometry
POPULATION: 36 Female subjects will be selected for thestudy.
The subjects selected for this study will be healthyfemales, aged between 18-40 years, complaining flaccid breast, withBMI-25-35kg/m2.
STUDY DURATION: 56days following the application of the product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 30
- 1)Indian / Asian female subjects 2)Healthy subjects 3) Skin is healthy on the studied anatomic unit 4) Volunteers complaining flaccid breast.
- 5)Body Mass Index- 25-35 kg/m2.
- 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 Improvement in breast firmness, breast shape & breast upliftment Baseline, Day 28, Day 56
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.🇮🇳Mumbai, MAHARASHTRA, IndiaDr Pooja YadavPrincipal investigator02243349191poojayadav@mascotspincontrol.in