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AzTrials

HealthyPhase 3NCT02195297

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

A Phase 3 study testing ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream in people with Healthy, run by Derming SRL.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Sep 2013to Oct 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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

About this study

Official title: 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)

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.

Conditions
Healthy
Being tested
ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
Keywords
cellulitis, anticellulitis
Medical subject headings
Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT02195297
Study groupRoleWhat they receive
ANTICELLULITE GMG GIULIANIActive comparatorEach 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.
Receives: Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream
SOMATOLINEActive comparatorEach 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.
Receives: Other: ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after 2 and 4 week-treatment

Secondary outcomes (6)

  1. 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).

    Measured: after 2 and 4 week-treatment

  2. 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.)

    Measured: after 2 and 4 week-treatment

  3. 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).

    Measured: after 2 and 4 week-treatment

  4. 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.

    Measured: after 2 and 4 week-treatment

  5. 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

    1. = shaded spots thermal image (hyperthermal images)
    2. = leopard spots (numerous hyperthermal images)
    3. = hypothermal black holes
    4. = uniform hypothermal image

    Measured: after 2 and 4 week-treatment

  6. 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

    Measured: after 2 and 4 week-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195297
Sponsor's protocol ID
E1513
Status last verified
Jul 2014
First submitted
10 Jul 2014
Last updated
21 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10442720

  • 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.

    PubMed 8401751

  • 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.

    PubMed 9253055

  • 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.

    PubMed 12674836

  • 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.

    PubMed 1485642

  • 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)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream in people with Healthy, run by Derming SRL.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphometric evaluations: change from baseline (T2 and T4 vs. T0) (time frame: after 2 and 4 week-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195297, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.

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