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Clinical study to assess the effectiveness of product on human volunteers

Not yet recruiting
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
Inclusion Criteria
  • 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.
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
NameTimeMethod
Improvement in breast firmness, breast shape & breast upliftmentBaseline, Day 28, Day 56
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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