Clinical Trials Register

Summary
EudraCT Number:	2020-003740-89
Sponsor's Protocol Code Number:	MR-Som-01-20
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-24
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-003740-89

A.3

Full title of the trial

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

Studio monocentrico, interventistico di fase IV, non controllato, per la valutazione di nuovi parametri clinici e strumentali sull’efficacia di SOMATOLINE nel trattamento delle adiposità localizzate e della cellulite

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

Efficacy of SOMATOLINE assessed with photonumeric severity scales

Valutazione dell'efficacia di SOMATOLINE tramite scale di severità fotonumerica

A.4.1

Sponsor's protocol code number

MR-Som-01-20

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Manetti & Roberts Spa
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Via Baldanzese 177
B.5.3.2	Town/ city	Calenzano (FI)
B.5.3.3	Post code	50141
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390558835320
B.5.6	E-mail	csabatini@manettiroberts.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUSTINE
D.2.1.1.2	Name of the Marketing Authorisation holder	SOCIETA' ITALO BRITANNICA L. MANETTI - H. ROBERTS e C. PER AZIONI
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUSTINE
D.3.2	Product code	[SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUS
D.3.4	Pharmaceutical form	Cutaneous emulsion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	levotiroxina
D.3.9.2	Current sponsor code	Manetti& Roberts
D.3.10	Strength
D.3.10.1	Concentration unit	IU/mg international unit(s)/milligram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	escina
D.3.9.2	Current sponsor code	Manetti & Roberts
D.3.10	Strength
D.3.10.1	Concentration unit	IU/mg international unit(s)/milligram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

local adiposity and cellulite

adiposità locale e cellulite

E.1.1.1

Medical condition in easily understood language

local adiposity and cellulite

depositi adiposi locali e cellulite

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10007882
E.1.2	Term	Cellulitis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

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

Valutare l’efficacia di SOMATOLINE nel trattamento della cellulite attraverso la riduzione verso basale dello score CSS misurato sulle cosce, a 14 e 28 gg di trattamento.

E.2.2

Secondary objectives of the trial

• Evaluation of the efficacy versus baseline, assessed as reduction of PR-PCSS e CR-PCSS scores, measured on the thighs, at 14 and 28 days of treatment
• Reduction of thigh circumference at 14 and 28 days of treatment
• Evaluation, by use of instrumental parameters, of the ultrasonographic structure of the cutaneous layers at 14 and 28 days of treatment
• Evaluation, by use of instrumental parameters, of the subcutaneous microcirculation at 14 and 28 days of treatment
• Patients’ evaluation of the satisfaction grade, compared to their expectations, and tolerability.
• Local and systemic safety and tolerability by evaluation of adverse events and laboratory thyroid function parameters.

• Valutazione dell’efficacia vs basale, determinata come riduzione degli score PR-PCSS e CR-PCSS misurati sulle cosce, a 14 e 28 gg di trattamento.
• Riduzione della circonferenza cosce a 14 e 28 gg di trattamento
• Valutazione, tramite parametri strumentali, della struttura ultrasonografica degli strati cutanei a 14 e 28 gg di trattamento.
• Valutazione, mediante l'uso di parametri strumentali, della microcircolazione sottocutanea a 14 e 28 giorni di trattamento.
• Valutazione da parte del paziente del grado di soddisfazione, rispetto alle aspettative, e della tollerabilità.
• Sicurezza e tollerabilità locale e sistemica mediante la valutazione degli eventi avversi, dei parametri di laboratorio della funzione tiroidea.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adult women between 18 and 50 years of age (limits included);
2. Caucasian race;
3. BMI (Body Mass Index) <30 and >18;
4. Score CSS >5 and =10 (moderate grade), assessed in the back of the right thigh;
5. Diastolic and systolic blood pressure, measured in supine position after 5-minute rest, = 90 mm/Hg and = 140 mm/Hg respectively;
6. Cardiac frequency, measured in supine position after 5-minute rest, = 50 and = 90 beats/minute;
7. Signature of the informed consent form.

1. Donne adulte di età compresa tra 18 e 50 anni (limiti inclusi)
2. Razza caucasica.
3. BMI (Body Mass Index) < 30 e > 18;
4. Score CSS >5 e =10 (grado moderato), valutato nella parte posteriore della coscia destra;
5. Pressione arteriosa, rilevata in clinostatismo dopo 5 minuti di riposo, inferiore o uguale a 90 mm/Hg ed a 140 mm/Hg rispettivamente per la diastolica e la sistolica.
6. Frequenza cardiaca rilevata in clinostatismo, dopo 5 minuti di riposo, compresa tra 50 e 90 battiti al minuto (limiti inclusi).
7. Firma del modulo del consenso informato.

E.4

Principal exclusion criteria

1. Pregnancy or breast-feeding in act;
2. Changes (start of interruption) of estrogen-progestin contraceptive use in the last 4 weeks;
3. Impossibility to use an adequate method of contraception during the study;
4. Any endocrinologic, in particular at thyroid level, disease or dysfunction, even asymptomatic;
5. Any acute or chronic disease in any body system detectable by the anamnesis;
6. Any clinically significant abnormalities detectable by the physical examination;
7. Any clinically significant abnormalities detectable by the ECG;
8. Any clinically significant abnormalities in the laboratory values;
9. History of allergy or intolerance to the investigational product and/or the excipients;
10. Ongoing treatments, or treatments stopped less than 4 weeks before the study entry, or intention to undergo during the study to treatments that involve interventions of any nature aimed to treat cellulite (drugs, medical devices, dermo cosmetics, mesotherapy);
11. Ongoing treatments, or treatments stopped less than 4 weeks before the study entry, or intention to undergo during the study to treatments that involve interventions of any nature aimed to weight loss and slimming (pharmacologic, dietetic, surgical, instrumental ones, etc);
12. Greater than 10% increase or decrease in body weight within past 6 months;
13. Intention to undertake, during the study, significant changes in the dietary regimen (i.e. food supplementation with iodized salt) or life changes;
14. Surgical interventions already planned to be performed during the study;
15. In the past 12 weeks:
¿ Treatment with SOMATOLINE;
¿ Treatments or therapies with iodine or use of drugs containing iodine (e.g. Amiodarone);
¿ Treatment with anti-thyroid drugs;
¿ Diagnostic investigations with tracers or contrast media containing iodine or its isotope;
¿ Use of antiseptics (e.g Betadine), cleansers, or any product for local or systemic use containing iodine including mouthwash (e.g. Iodosan), iodized toothpastes, vaginal lavage (e.g, Lugol solutions);
16. Abuse of alcohol (> 75 g/day of ethanol), xanthine (>5 cups/day), or tobacco (> 10 cigarettes/day), or use of psychotropic drugs (with the exception of occasional use of hypno-inducers) or any drug abuse.
17. Blood donation or haemorrhage in the past 3 months or intention to donate blood during the study or in the 4 weeks following the study end.
18. Inability, for linguistic or psychological reasons, to fully understand the information given to obtain consent or refuse to give written consent.
19. Participation to any other interventional study in the past 4 weeks or will to take part to other trials with investigational drugs during the present study

1. Gravidanza o allattamento al seno in atto.
2. Modifiche (inizio o sospensione) dell’uso di contraccettivi estro-progestinici nelle ultime 4 settimane.
3. Impossibilità di adottare una contraccezione adeguata durante la fase di studio.
4. Qualsiasi malattia o disfunzione, anche asintomatica, di rilievo endocrinologico e tiroideo in particolare.
5. Qualsiasi malattia acuta o cronica a carico di qualsiasi apparato rilevabile all’anamnesi.
6. Qualsiasi anomalia clinicamente significativa rilevabile all’esame obiettivo.
7. Qualsiasi anomalia clinicamente significativa rilevabile all’ECG.
8. Qualsiasi anomalia clinicamente significativa dei valori di laboratorio.
9. Storia di allergia o intolleranza ai prodotti in studio e/o agli eccipienti.
10. Trattamenti in corso, oppure completati da meno di 4 settimane, oppure intenzione di sottoporvisi nel corso dello studio, che implicano provvedimenti di qualunque natura finalizzati al trattamento della cellulite (farmacologici, dispositivi medici, dermocosmetici, mesoterapia, ecc.).
11. Trattamenti in corso, oppure completati da meno di 4 settimane, oppure intenzione di sottoporvisi nel corso dello studio, che implicano provvedimenti di qualunque natura finalizzati alla riduzione di peso o al dimagrimento (farmacologici, dietetici, chirurgici, strumentali, ecc.).
12. Aumento o diminuzione maggiore del 10% del peso corporeo negli ultimi 6 mesi;
13. Intenzione di adottare, nel corso dello studio, cambiamenti significativi nel regime dietetico (es. integrazione alimentare con sale iodato) oppure nello stile di vita.
14. Interventi chirurgici già programmati da effettuarsi nel corso dello studio.
15. Nelle ultime 12 settimane:
• Trattamenti con Somatoline;
• Trattamenti o terapie a base di iodio o uso di farmaci contenenti iodio (es. Amiodarone);
• Trattamenti con farmaci antitiroidei;
• Indagini diagnostiche che abbiano comportato l’impiego di traccianti o mezzi di contrasto contenenti iodio o suoi isotopi.
• Uso di disinfettanti (es. Betadine), detergenti o qualsiasi prodotto per uso sistemico o topico contenente iodio, compresi colluttori (es. Iodosan), dentifrici iodati, lavande vaginali, soluzioni di Lugol.
16. Abuso di alcool (oltre 75 g/die di etanolo), xantine (oltre 5 tazze/die), tabacco (oltre 10 sigarette/die) oppure uso di psicofarmaci (tranne che per occasionale impiego come ipno-induttori) o di qualsiasi droga.
17. Donazioni di sangue o emorragie nei tre mesi precedenti oppure intenzione di donare sangue durante lo studio o nelle 4 settimane successive la conclusione dello studio.
18. Soggetti impossibilitati, per motivi linguistici o psicologici, di comprendere le informazioni date per l’ottenimento del consenso o che rifiutino di dare il proprio consenso in forma scritta.
19. Altro studio clinico nelle quattro settimane precedenti o durante questo studio o intenzione di prendere parte ad uno studio con farmaci sperimentali durante la presente indagine.

E.5 End points

E.5.1

Primary end point(s)

Reduction of at least 2 points in the thigh CSS score after 28 days of treatment

Riduzione di almeno 2 punti nello score CSS cosce dopo 28 gg di trattamento

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 gg

E.5.2

Secondary end point(s)

•• Riduzione degli score PR-PCSS e CR-PCSS misurati sulle cosce, a 14 e 28 gg di trattamento.
• Riduzione della circonferenza cosce a 14 e 28 gg di trattamento
• Valutazione della struttura ultrasonografica degli strati cutanei a 14 e 28 gg di trattamento.
• Valutazione della microcircolazione sottocutanea a 14 e 28 giorni di trattamento
• Valutazione da parte del paziente del grado di soddisfazione, rispetto alle aspettative, e della tollerabilità.; • Local and systemic safety and tolerability by evaluation of adverse events and laboratory thyroid function parameters.

• Reduction of PR-PCSS e CR-PCSS scores, measured on the thighs, at 14 and 28 days of treatment
• Reduction of thigh circumference at 14 and 28 days of treatment
• Evaluation of the ultrasonographic structure of the cutaneous layers at 14 and 28 days of treatment
• Evaluation of the subcutaneous microcirculation at 14 and 28 days of treatment
• Patients’ evaluation of the satisfaction grade, compared to their expectations, and tolerability.; • Sicurezza e tollerabilità locale e sistemica mediante la valutazione degli eventi avversi, dei parametri di laboratorio della funzione tiroidea.

E.5.2.1

Timepoint(s) of evaluation of this end point

14 and 28 days; All time points (14, 28,42 days)

14 e 28 gg; A tutti i time points (14,28 e 42 giorni)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not expected particular cares at the end of the study

, non sono previste cure particolari al termine dello studio

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-04-05

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