<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195297</url>
  </required_header>
  <id_info>
    <org_study_id>E1513</org_study_id>
    <nct_id>NCT02195297</nct_id>
  </id_info>
  <brief_title>Evaluation of the Activity of a Pharmacological &quot;Anticellulitis&quot; Product vs. a Reference Product on the Market</brief_title>
  <official_title>Clinical and Instrumental Evaluation of the Activity of a Pharmacological &quot;Anticellulitis&quot; Product vs. a Reference Product on the Market: Comparison Within Subjects (Double Blind Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental&#xD;
      evaluations the activity of an &quot;anticellulitis&quot; cosmetic product vs a reference product of&#xD;
      the market (comparison within subjects), applied once a day, for an uninterrupted period of 4&#xD;
      weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic&#xD;
      lipodystrophy on the thighs.&#xD;
&#xD;
      It was also aim of the study to evaluate cosmetic acceptability by the volunteers and&#xD;
      products efficacy and tolerance both by investigator and volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphometric evaluations: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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 (&quot;torque on&quot;) and after it has ceased (&quot;torque off&quot;). For each of the considered curves it was measured the cutaneous rotational ratio relative to defined measured times, obtaining the parameters listed below:&#xD;
Ue: immediate extensibility (&quot;torque on&quot; at 0.2 sec.) Uf: final extensibility (&quot;torque on&quot; at 9 sec.) Uv: viscoelasticity Ur: immediate elastic recovery (&quot;torque off&quot; at 0.2 sec.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical densitometry: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermography evaluation: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>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:&#xD;
0 = uniform hyperthermal image&#xD;
= shaded spots thermal image (hyperthermal images)&#xD;
= leopard spots (numerous hyperthermal images)&#xD;
= hypothermal black holes&#xD;
= uniform hypothermal image</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluations: change from baseline (T2 and T4 vs. T0)</measure>
    <time_frame>after 2 and 4 week-treatment</time_frame>
    <description>Performed at level of the III superior, of the III middle and inferior of the thigh:&#xD;
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&#xD;
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&#xD;
pain at pinching absent 0 slight 1 medium 2 consistent 3 very consistent 4&#xD;
firmness (internal thigh) very poor 0 poor 1 medium 2 good 3 very good 4&#xD;
smoothness very poor 0 poor 1 medium 2 good 3 very good 4</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ANTICELLULITE GMG GIULIANI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOMATOLINE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream</intervention_name>
    <description>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)</description>
    <arm_group_label>ANTICELLULITE GMG GIULIANI</arm_group_label>
    <arm_group_label>SOMATOLINE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female volunteers&#xD;
&#xD;
          -  volunteers aged more than 18 years old&#xD;
&#xD;
          -  volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs&#xD;
&#xD;
          -  volunteers with no weight variation (± 1.5 kg) during the last month preceding the&#xD;
             study inclusion&#xD;
&#xD;
          -  volunteers with regular menstrual cycle (28-32 days) or in menopause from at least 2&#xD;
             years&#xD;
&#xD;
          -  volunteers who are giving a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  smoke (admitted 10 cigarettes/day)&#xD;
&#xD;
          -  assumption of alcoholic drinks/wine/beer (admitted up to 125 ml for meal)&#xD;
&#xD;
          -  oral contraceptive/replacement therapy started less than 1 year ago&#xD;
&#xD;
          -  alimentary diet&#xD;
&#xD;
          -  change in the normal habits in the last month (unusual physical activity)&#xD;
&#xD;
          -  use of any product or weight-loss treatment (manual or instrumental massage) on skin&#xD;
             test areas during the last month&#xD;
&#xD;
          -  use of any drug able to cause a weight body variation&#xD;
&#xD;
          -  presence of clinically important vascular disorders&#xD;
&#xD;
          -  insufficient adhesion to the study protocol and to the treatment&#xD;
&#xD;
          -  participation in a similar study during the previous month&#xD;
&#xD;
          -  dermatological disease&#xD;
&#xD;
          -  clinical and significant skin condition on the test area (e.g. lesions, scars,&#xD;
             malformations)&#xD;
&#xD;
          -  suspect thyroid disfunction&#xD;
&#xD;
          -  thyroid disorders/diseases&#xD;
&#xD;
          -  other endocrine diseases as diabetes, metabolic disorders etc.&#xD;
&#xD;
          -  hepatic, renal or cardiac disorder&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  topical drugs or surgical procedure on the test areas during the previous 3 months&#xD;
&#xD;
          -  systemic corticosteroids&#xD;
&#xD;
          -  aspirin or non-steroid anti-inflammatory drugs (FANS)&#xD;
&#xD;
          -  diuretic drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adele Sparavigna, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Derming SRL</affiliation>
  </overall_official>
  <link>
    <url>http://www.derming.com/</url>
    <description>Investigation center</description>
  </link>
  <link>
    <url>http://www.giulianipharma.com/</url>
    <description>Sponsor</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>10442720</PMID>
  </reference>
  <reference>
    <citation>Bellisari A. Sonographic Measurement of adipose tissue. J. Diagn. Med. Sonogr., 9 (1): 11-18, 1993</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8401751</PMID>
  </reference>
  <reference>
    <citation>Curri SB. Cellulite. Doctor dermatologia, 1: 39-52,1991.</citation>
  </reference>
  <reference>
    <citation>Curri SB. Adiposità localizzata e pannicolopatia edemato-fibrosclerotica. Sepem, Milano, 1990</citation>
  </reference>
  <reference>
    <citation>De Rigal J, Leveque JL. In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985</citation>
  </reference>
  <reference>
    <citation>Fernay, Voltaire. The World Medical Association (1989) &quot;World Medical Association Declaration of Helsinki&quot;, Hong-Kong.</citation>
  </reference>
  <reference>
    <citation>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)</citation>
  </reference>
  <reference>
    <citation>Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D)Skin Res Technol, Vol 11: 292, (2005)</citation>
  </reference>
  <reference>
    <citation>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)</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9253055</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12674836</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1485642</PMID>
  </reference>
  <reference>
    <citation>Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172, (1964)</citation>
  </reference>
  <reference>
    <citation>Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer,:536-539, (1981)</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19272125</PMID>
  </reference>
  <reference>
    <citation>Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, (1988)</citation>
  </reference>
  <reference>
    <citation>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)</citation>
  </reference>
  <reference>
    <citation>Sparavigna A., Galbiati G. La plastoelasticità cuanea: Metodi di indagine e significato clinico Chronica Dermatologica 4: 509-517, (1992)</citation>
  </reference>
  <reference>
    <citation>Sparavigna A., Setaro M. Misurazione delle propietà meccaniche della cute mediante metodi di torsione In:&quot;Diagnostica non invasiva in dermatologia&quot; A cura di Stefania Seidenari, EDRA Medical Publishing &amp; New Media, Milano, Pagg. 323-328, (1998)</citation>
  </reference>
  <reference>
    <citation>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)</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19627407</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cellulitis</keyword>
  <keyword>anticellulitis</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195297
org study id: E1513
nct id: NCT02195297
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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.
measure: Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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).
measure: Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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.)
measure: Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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).
measure: Optical densitometry: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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.
measure: Thermography evaluation: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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
measure: Clinical evaluations: change from baseline (T2 and T4 vs. T0)
time frame: after 2 and 4 week-treatment
description: 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
arm group label: ANTICELLULITE GMG GIULIANI
arm group type: Active Comparator
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.
arm group label: SOMATOLINE
arm group type: Active Comparator
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.
intervention type: Other
intervention name: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
description: 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)
arm group label: ANTICELLULITE GMG GIULIANI
arm group label: SOMATOLINE
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adele Sparavigna, Doctor
role: Principal Investigator
affiliation: Derming SRL
url: http://www.derming.com/
description: Investigation center
url: http://www.giulianipharma.com/
description: Sponsor
citation: 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.
PMID: 10442720
citation: Bellisari A. Sonographic Measurement of adipose tissue. J. Diagn. Med. Sonogr., 9 (1): 11-18, 1993
citation: 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.
PMID: 8401751
citation: Curri SB. Cellulite. Doctor dermatologia, 1: 39-52,1991.
citation: Curri SB. Adiposità localizzata e pannicolopatia edemato-fibrosclerotica. Sepem, Milano, 1990
citation: De Rigal J, Leveque JL. In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985
citation: Fernay, Voltaire. The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong.
citation: 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)
citation: Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D)Skin Res Technol, Vol 11: 292, (2005)
citation: 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)
citation: 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.
PMID: 9253055
citation: 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.
PMID: 12674836
citation: 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.
PMID: 1485642
citation: Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172, (1964)
citation: Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer,:536-539, (1981)
citation: 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.
PMID: 19272125
citation: Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, (1988)
citation: 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)
citation: Sparavigna A., Galbiati G. La plastoelasticità cuanea: Metodi di indagine e significato clinico Chronica Dermatologica 4: 509-517, (1992)
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PMID: 19627407
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