Status:
COMPLETED
Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market
Lead Sponsor:
Derming SRL
Conditions:
Healthy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 (compari...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02195297
Start Date
September 1 2013
End Date
October 1 2013
Last Update
July 21 2014
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