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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANTICELLULITE GMG GIULIANI<br>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. | Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream<br>* Products application: mono-laterally, once a day at evening (4 doses from each dispenser for the first 2 day-treatment and 2 doses for the following days)<br>|
| Active Comparator: SOMATOLINE<br>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. | Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream<br>* Products application: mono-laterally, once a day at evening (4 doses from each dispenser for the first 2 day-treatment and 2 doses for the following days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphometric evaluations: change from baseline (T2 and T4 vs. T0) | 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. | after 2 and 4 week-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0) | Ultrasonographic measurement of adipose panniculum thickness (mm) was performed at level of the external thigh (III superior) through the instrument Body Metrix™ BX 2000 (Genex). | after 2 and 4 week-treatment | 
| Skin plastoelasticity: change from baseline (T2 and T4 vs. T0) | Skin elasticity was measured through the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). This instrument is based on the principle of the torsion given to the skin surface by a probe made of two circles that adhere to the skin through shaped adhesive tapes. The instrument measures the torsion angle (θ) during the mechanical stimulus (torque on) and after it has ceased (torque off). For each of the considered curves it was measured the cutaneous rotational ratio relative to defined measured times, obtaining the parameters listed below: Ue: immediate extensibility (torque on at 0.2 sec.) Uf: final extensibility (torque on at 9 sec.) Uv: viscoelasticity Ur: immediate elastic recovery (torque off at 0.2 sec.) | after 2 and 4 week-treatment | 
| Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0) | Tissue dielectric constant of deep skin layers misures non-invasively the dielectric constant of the subcutaneous fat; it is a dimensionless physical quantity and it is directly proportional to the water content in the measured tissue. The used probe corresponds to an effective measurement depth of 5 mm; the measure were performed at level of the external thigh (III superior). | after 2 and 4 week-treatment | 
| Optical densitometry: change from baseline (T2 and T4 vs. T0) | The measurement of the skin erythema at level of the internal area of the knee was performed by the use of an optical densitometer (X-RITE 404) allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan, where R represents the reflectance. | after 2 and 4 week-treatment | 
| Thermography evaluation: change from baseline (T2 and T4 vs. T0) | Contact thermography permits visualizing, through colors, the temperatures of the areas being examined by using encapsulated liquid crystals plates; it allows to detect information about cutaneous microcirculation in normal conditions, after functional stimuli or vasoactive treatments: skin temperature grows in case of vasodilatation, increase of blood vessels, increase local metabolism and reduced in case of vasoconstriction, pathological decrease of blood vessels, decrease of local metabolism, oedema and increase of adipose tissue. A characteristic thermography aspect of legs' oedematous - fibrosclerotic lipodystrophy is represented by the typical leopard skin with large hypothermic zones. Panniculopatia evaluation follows next classification: 0 = uniform hyperthermal image = shaded spots thermal image (hyperthermal images) = leopard spots (numerous hyperthermal images) = hypothermal black holes = uniform hypothermal image | after 2 and 4 week-treatment | 
| Clinical evaluations: change from baseline (T2 and T4 vs. T0) | Performed at level of the III superior, of the III middle and inferior of the thigh: cellulitis visual aspect (according to a reference photographic scale) no cellulitis 0 slight dimpling on skin surface 1 dimpling and skin depressions 2 dimpling and depressed striations 3 nodules and depressed striations 4 cellulitis aspect to pinching ( according to a reference photographic scale) no cellulitis 0 slight dimpling on skin surface 1 dimpling and skin depressions 2 dimpling and depressed striations 3 nodules and depressed striations 4 pain at pinching absent 0 slight 1 medium 2 consistent 3 very consistent 4 firmness (internal thigh) very poor 0 poor 1 medium 2 good 3 very good 4 smoothness very poor 0 poor 1 medium 2 good 3 very good 4 | after 2 and 4 week-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cellulitis, anticellulitis