Clinical Trial Results:
A Phase IV, interventional, monocentric, not controlled study for the evaluation of new clinical and instrumental parameters on the efficacy of SOMATOLINE in the treatment of local adiposity and cellulite
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Summary
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EudraCT number |
2020-003740-89 |
Trial protocol |
IT |
Global end of trial date |
05 Apr 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Apr 2023
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First version publication date |
19 Apr 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MR-Som-01-20
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Manetti & Roberts Spa
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Sponsor organisation address |
Via Baldanzese 177, Calenzani/Firenze, Italy, 50141
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Public contact |
Regulatory Affairs, Manetti & Roberts Spa, 0039 00390558835320, csabatini@manettiroberts.it
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Scientific contact |
Regulatory Affairs, Manetti & Roberts Spa, 0039 0558835320, csabatini@manettiroberts.it
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Oct 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Apr 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Apr 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy of SOMATOLINE in the treatment of cellulite by the reduction versus baseline of CSS score measured in the thighs at 14 and 28 days of treatment
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Protection of trial subjects |
Informed consent and data privacy was signed by all the subjects. According with available safety data, the risks to patients were considered hardly distinguishable from those of placebo. The safety of the cutaneous use of SOMATOLINE rests in fact on biochemical and pharmacological bases, on results of bioavailability studies that document the lack of circulation of significant portions of levo-thyroxine, on controlled clinical studies and on pharmacovigilance data of over 40 years marketing of the product.
This study did not imply the presence of a placebo arm, so the expected benefits for the patient were considered, from the clinical point of view and for the duration of the study, substantially superimposable to those already clinically documented for SOMATOLINE, even if in the studies conducted so far, the benefits were not assessed with recent and validated rating scales.
The favorable risk / benefit ratio of SOMATOLINE, the wide knowledge of its pharmacological and therapeutic profile, the inclusion and exclusion criteria related to the protocol and the short duration of the study did not require sophisticated risk mitigation measures.
The fortnightly check-ups in the first phase of the study and the self-assessment by the patient, required by the protocol, were considered adequate to monitor and, if necessary, to take measure to control and to mitigate the critical issues and risks to which patients may be exposed.
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Background therapy |
Due to the nature of the disease under study ( cellulite) no background therapy was planned. | ||
Evidence for comparator |
No comparator was used for this study | ||
Actual start date of recruitment |
22 Feb 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
In the period between 22/02/2021 and 14/02/2022, the Dermatology Division screened 35 women, 24 met all inclusion/excusion criteria and were enrolled | ||||||||||
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Pre-assignment
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Screening details |
Out of 35 patients screened, 11 patients were screening failures. For 8 patients out of 11 (72.7%) the cause of exclusion was evidence of thyroid abnormalities or dysfunction. | ||||||||||
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Period 1
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Period 1 title |
all trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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somatoline | ||||||||||
Arm description |
Levothyroxine 0,1% + escin 0,3% | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Somatoline (Levothyroxine 0,1% + escin 0,3%)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous emulsion
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Routes of administration |
Cutaneous use
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Dosage and administration details |
2 sachets/day on the thighs for the first two days (10 g /die) , followed by one sachet (5 g for each thigh) up to 4 weeks
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Baseline characteristics reporting groups
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Reporting group title |
all trial
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Reporting group description |
A total of 24 adult women 33.4 (±6.1) years old (range 26-47) received at least one dose of SOMATOLINE and were all included in the ITT data set. All the patients adopted contraceptive methods. No comorbidities, concomitant treatments and abnormalities at the physical examination were reported at screening; only, 2 patients suffered from minor ECG abnormalities: slight bundle branch block and left axial deviation. 6 patients were light smokers (mean 6.2 cigarettes per day, range 1-10) and only 8 occasionally drank alcohol; sports activities, always moderate, were practiced by 11 patients out of 24 (45.8%). The patients declared a daily consumption of water outside meals of half liter or less in 25,0% (6/24) of cases, more than half liter, up to one liter, in 29,2% (7/24) and more than one liter in 45,8% (11/24) of the cases. All the patients but 3 (12.5%), referred a normal or moderate sodium intake. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The "Intention To Treat Set" (ITT) comprised all subjects who received at least one application of IMP, regardless of the treatment status
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Subject analysis set title |
Per Protocol set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The "Per-Protocol Set" (PP) comprised all subjects in the ITT set, with the exclusion of subjects with major protocol deviations
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End points reporting groups
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Reporting group title |
somatoline
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Reporting group description |
Levothyroxine 0,1% + escin 0,3% | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The "Intention To Treat Set" (ITT) comprised all subjects who received at least one application of IMP, regardless of the treatment status
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Subject analysis set title |
Per Protocol set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The "Per-Protocol Set" (PP) comprised all subjects in the ITT set, with the exclusion of subjects with major protocol deviations
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End point title |
Primary end-point [1] | ||||||||||||
End point description |
Proportion of patients with reduction of at least 2 points in the thigh CSS (Cellulite Severy Scale) score
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End point type |
Primary
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End point timeframe |
28 days
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses can be uploaded since it is one arm study. |
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Attachments |
primary end-point - ITT and PP sets |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Secondary end-points | |||||||||
End point description |
The secondary end-points listed in the study protocol were:
a) Evolution of CSS score measured on the thighs at 14 and 28 days of treatment.
b) Evolution of CSS subscores measured on the thighs at 14 and 28 days of treatment.
c) Evolution of PR-PCSS at 14 and 28 days of treatment.
d) Percentage of patients who achieved a composite ≥1-level improvement from baseline in CR-PCSS rating and PR-PCSS rating (secondary composite end point)
e) Evolution of thigh circumference measurements assessed at baseline, 14 and 28 days of treatment
f) Changes in ultrasonographic structure of the cutaneous layers at 14 and 28 days of treatment
g) Change in subcutaneous microcirculation trough Laser Doppler Flowmetry
h) Patients’ evaluation of the satisfaction.
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End point type |
Secondary
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End point timeframe |
14 and 28 days of treatment
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Attachments |
Secondary End-points ITT set |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
From Informed Consent Signature to End of Study
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Somatoline
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Reporting group description |
all patients enrolled (single arm) | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No serious adverse events occurred; this was a study on young women with cellulite and study duration was 42 days per subject. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Study limitations: There was no control arm, even if a chronic condition like cellulite mitigates the problem. This study involved a small sample size and a short treatment duration, typically a half, or less, of the recommended treatment duration. | |||
