Clinical trial NCT02195297: Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: cellulitis
anticellulitis
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* insufficient adhesion to the study protocol and to the treatment
* participation in a similar study during the previous month
* dermatological disease
* clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
* suspect thyroid disfunction
* thyroid disorders/diseases
* other endocrine diseases as diabetes, metabolic disorders etc.
* hepatic, renal or cardiac disorder
* cancer
* topical drugs or surgical procedure on the test areas during the previous 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic drugs

Primary outcomes:
measure: Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
Secondary outcomes:
measure: Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
measure: Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
measure: Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
measure: Optical densitometry: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
measure: Thermography evaluation: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
measure: Clinical evaluations: change from baseline (T2 and T4 vs. T0)
timeFrame: after 2 and 4 week-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Derming SRL
name: Adele Sparavigna, Doctor
role: PRINCIPAL_INVESTIGATOR
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