NCT02195297

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 (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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

July 10, 2014

Last Update Submit

July 17, 2014

Conditions

Healthy

Keywords

cellulitisanticellulitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)

    after 2 and 4 week-treatment

  • Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)

    after 2 and 4 week-treatment

  • Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)

    after 2 and 4 week-treatment

  • Optical densitometry: change from baseline (T2 and T4 vs. T0)

    after 2 and 4 week-treatment

  • Thermography evaluation: change from baseline (T2 and T4 vs. T0)

    after 2 and 4 week-treatment

  • +1 more secondary outcomes

Study Arms (2)

ANTICELLULITE GMG GIULIANI

ACTIVE COMPARATOR

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

SOMATOLINE

ACTIVE COMPARATOR

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

Interventions

ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE CreamOTHER

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)

ANTICELLULITE GMG GIULIANISOMATOLINE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female volunteers
  • volunteers aged more than 18 years old
  • volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs
  • volunteers with regular menstrual cycle (28-32 days) or in menopause from at least 2 years
  • volunteers who are giving a written informed consent.

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • 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: 10442720BACKGROUND

  • Bellisari A. Sonographic Measurement of adipose tissue. J. Diagn. Med. Sonogr., 9 (1): 11-18, 1993

    BACKGROUND

  • 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: 8401751BACKGROUND

  • Curri SB. Cellulite. Doctor dermatologia, 1: 39-52,1991.

    BACKGROUND

  • Curri SB. Adiposità localizzata e pannicolopatia edemato-fibrosclerotica. Sepem, Milano, 1990

    BACKGROUND

  • De Rigal J, Leveque JL. In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985

    BACKGROUND

  • Fernay, Voltaire. The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong.

    BACKGROUND

  • 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)

    BACKGROUND

  • Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D)Skin Res Technol, Vol 11: 292, (2005)

    BACKGROUND

  • 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)

    BACKGROUND

  • 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: 9253055BACKGROUND

  • 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: 12674836BACKGROUND

  • 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: 1485642BACKGROUND

  • Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172, (1964)

    BACKGROUND

  • Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer,:536-539, (1981)

    BACKGROUND

  • 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: 19272125BACKGROUND

  • Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, (1988)

    BACKGROUND

  • 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)

    BACKGROUND

  • Sparavigna A., Galbiati G. La plastoelasticità cuanea: Metodi di indagine e significato clinico Chronica Dermatologica 4: 509-517, (1992)

    BACKGROUND

  • 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)

    BACKGROUND

  • 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)

    BACKGROUND

  • 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.

    PMID: 19627407BACKGROUND

Related Links

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adele Sparavigna, Doctor

    Derming SRL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 21, 2014

Study Start

September 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 21, 2014

Record last verified: 2014-07