local adiposity and cellulite MedDRA version: 20.0 Level: PT Classification code 10007882 Term: Cellulitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUSTINE
Product Name: SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUSTINE
Product Code: [SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 30 BUS
P
Sponsors
SOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women between 18 and 50 years of age (limits included); 2. Caucasian race; 3. BMI (Body Mass Index) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: •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.;Primary end point(s): Reduction of at least 2 points in the thigh CSS score after 28 days of treatment;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 14 and 28 days; All time points (14, 28,42 days) | — |
Countries
Italy
Contacts
Public ContactRegulatory Affairs
Manetti & Roberts Spa
Outcome results
None listed