Clinical and Instrumental Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market: Comparison Within Subjects (Double Blind Study)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Derming SRL
- Enrollment
- 22
- Primary Endpoint
- Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental evaluations the activity of an "anticellulitis" cosmetic product vs a reference product of the market (comparison within subjects), applied once a day, for an uninterrupted period of 4 weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs.
It was also aim of the study to evaluate cosmetic acceptability by the volunteers and products efficacy and tolerance both by investigator and volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •female volunteers
- •volunteers aged more than 18 years old
- •volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs
- •volunteers with no weight variation (± 1.5 kg) during the last month preceding the study inclusion
- •volunteers with regular menstrual cycle (28-32 days) or in menopause from at least 2 years
- •volunteers who are giving a written informed consent.
Exclusion Criteria
- •pregnancy
- •lactation
- •smoke (admitted 10 cigarettes/day)
- •assumption of alcoholic drinks/wine/beer (admitted up to 125 ml for meal)
- •oral contraceptive/replacement therapy started less than 1 year ago
- •alimentary diet
- •change in the normal habits in the last month (unusual physical activity)
- •use of any product or weight-loss treatment (manual or instrumental massage) on skin test areas during the last month
- •use of any drug able to cause a weight body variation
- •presence of clinically important vascular disorders
Outcomes
Primary Outcomes
Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
Time Frame: after 2 and 4 week-treatment
All the measures were performed in standard conditions at level of the thigh (III superior, III middle and inferior), thanks to a specific electro-optical system.
Secondary Outcomes
- Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Thermography evaluation: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Optical densitometry: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Clinical evaluations: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)