Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market

Derming

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02195297

E1513

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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22 participants in 2 patient groups

ANTICELLULITE GMG GIULIANI

Active Comparator group

Description:

Each included subject applied ANTICELLULITE GMG GIULIANI mono-laterally (on the left or on right side according to a previously defined randomization list) once a day, at evening, for an uninterrupted period of 4 weeks.

Treatment:

Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream

SOMATOLINE

Active Comparator group

Description:

Each included subject applied SOMATOLINE CREAM mono-laterally (on the left or on right side according to a previously defined randomization list) once a day, at evening, for an uninterrupted period of 4 weeks.

Treatment:

Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream