Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market
NCT ID: NCT02195297
Last Updated: 2014-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2013-09-30
2013-10-31
Brief Summary
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It was also aim of the study to evaluate cosmetic acceptability by the volunteers and products efficacy and tolerance both by investigator and volunteers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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ANTICELLULITE GMG GIULIANI
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.
ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
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)
SOMATOLINE
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.
ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
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)
Interventions
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ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Derming SRL
OTHER
Responsible Party
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Principal Investigators
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Adele Sparavigna, Doctor
Role: PRINCIPAL_INVESTIGATOR
Derming SRL
References
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Alanen E, Lahtinen T, Nuutinen J. Penetration of electromagnetic fields of an open-ended coaxial probe between 1 MHz and 1 GHz in dielectric skin measurements. Phys Med Biol. 1999 Jul;44(7):N169-76. doi: 10.1088/0031-9155/44/7/404.
Bellisari A. Sonographic Measurement of adipose tissue. J. Diagn. Med. Sonogr., 9 (1): 11-18, 1993
Bellisari A, Roche AF, Siervogel RM. Reliability of B-mode ultrasonic measurements of subcutaneous adipose tissue and intra-abdominal depth: comparisons with skinfold thicknesses. Int J Obes Relat Metab Disord. 1993 Aug;17(8):475-80.
Curri SB. Cellulite. Doctor dermatologia, 1: 39-52,1991.
Curri SB. Adiposità localizzata e pannicolopatia edemato-fibrosclerotica. Sepem, Milano, 1990
De Rigal J, Leveque JL. In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985
Fernay, Voltaire. The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong.
ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May (1996)
Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D)Skin Res Technol, Vol 11: 292, (2005)
Lahtinen, T., Nuutinen, J., Alanen, E. Dielectric properties of the skin In: Radio Frequency Radiation Dosimetry. Editors: B. J. Klauenberg and D. Miklavcic. Kluwer Academic Publishers, the Netherlands, (2000)
Lahtinen T, Nuutinen J, Alanen E. Dielectric properties of the skin. Phys Med Biol. 1997 Jul;42(7):1471-2. doi: 10.1088/0031-9155/42/7/020. No abstract available.
Radic R, Nikolic V, Karner I, Kurbel S, Selthofer R. Ultrasound measurement in defining the regional distribution of subcutaneous fat tissue. Coll Antropol. 2002 Dec;26 Suppl:59-68.
Ramirez ME. Measurement of subcutaneous adipose tissue using ultrasound images. Am J Phys Anthropol. 1992 Nov;89(3):347-57. doi: 10.1002/ajpa.1330890308.
Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172, (1964)
Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer,:536-539, (1981)
Salter DC, McArthur HC, Crosse JE, Dickens AD. Skin mechanics measured in vivo using torsion: a new and accurate model more sensitive to age, sex and moisturizing treatment. Int J Cosmet Sci. 1993 Oct;15(5):200-18. doi: 10.1111/j.1467-2494.1993.tb00075.x.
Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, (1988)
Sparavigna A., Setaro M., A new evaluation method of skin plastoelasticity in skin pharmacology and toxicology. Recent advances. Plenum Publishing Corporation, New York, London: 295-298, (1990)
Sparavigna A., Galbiati G. La plastoelasticità cuanea: Metodi di indagine e significato clinico Chronica Dermatologica 4: 509-517, (1992)
Sparavigna A., Setaro M. Misurazione delle propietà meccaniche della cute mediante metodi di torsione In:"Diagnostica non invasiva in dermatologia" A cura di Stefania Seidenari, EDRA Medical Publishing & New Media, Milano, Pagg. 323-328, (1998)
Van de Vijver LPL, Boelsma E, Bausch-Goldbohm RA, Roza L Subjective skin condition and its association with objective skin measurements. Cosm Toil: 118: 45-54, (2003)
Bayrakci Tunay V, Akbayrak T, Bakar Y, Kayihan H, Ergun N. Effects of mechanical massage, manual lymphatic drainage and connective tissue manipulation techniques on fat mass in women with cellulite. J Eur Acad Dermatol Venereol. 2010 Feb;24(2):138-42. doi: 10.1111/j.1468-3083.2009.03355.x. Epub 2009 Jul 13.
Related Links
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Sponsor
Other Identifiers
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E1513
Identifier Type: -
Identifier Source: org_study_id
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