Edematous fibrosclerotic panniculopathy MedDRA version: 20.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 10 BUSTINE
Product Name: Somatoline¿ gel
Product Code: Somatoline¿ gel
Pharmaceutical Form: Gel
INN or Proposed INN: 00179300
CAS Number: 51-48-9
Sponsors
SOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy woman will be enrolled in the study if they meet all the following inclusion criteria: • Sex and age: Adult women aged between 18 and 50 years; • Race: Caucasian; • Body mass index (BMI): 18.5 > BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women will be excluded from the study if they meet anyone of the following inclusion criteria: • Pregnancy: pregnant or lactating women; • ECG: clinically relevant abnormalities; • Physical findings: clinically relevant abnormal physical findings which could interfere with the study objectives; • Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; • Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations’ ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considered to potentially affect the outcome of the study; • Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine (in particular, thyroid), or neurological diseases, which may interfere with the aim of the study, history of gastric mucosal damages, neoplasia; • Contraceptive: changes (early or suspension) of the use of contraceptive oestrogen-progestin in the last 4 weeks, and inability to take adequate contraception during the study; • Medications and diet: any medication, including OTC, is forbidden during the screening period. Moreover: - In the 6 months before screening, any treatment with antithyroid drugs or any therapeutic use of iodine or iodine-containing medications (e.g., amiodarone, Somatoline®) is forbidden; - In the 6 months before screening, any diagnostic tests that led to the use of tracers, contrast agents containing iodine or iodine isotopes, is forbidden; - in the 4 weeks before screening, no changes in diet of foods containing iodine (e.g., iodized salt), or use disinfectants (e.g., betadine), detergents or any systemic or topical product containing iodine, including mouthwashes (e.g., Iodosan), toothpaste iodinated, douches, Lugol's solution; - In the 4 weeks before screening, any use of food supplements and herbal medicines; - a daily intake of iodized salt 1 drink/day for females defined according to USDA Dietary Guidelines 2000] or tobacco abuse (> 10 cigarettes/day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the systemic bioavailability of l-T4 in female subjects with after repeated cutaneous of a gel formulation of Somatoline¿ for 28 days.;Secondary Objective: The secondary objectives of the study are: - to assess the systemic bioavailability of rT3, T3 and TSH, after repeated cutaneous application of a gel formulation of Somatoline¿ in female subjects - to assess the local and systemic tolerability after repeated cutaneous application of a gel formulation of Somatoline¿ in female subjects;Primary end point(s): To assess the systemic bioavailability of l-T4.;Timepoint(s) of evaluation of this end point: Blood samples for measurement of TSH concentrations will be collected during the Screening (Day -15 to Day 0), Control 1 (Day 0 – Hour 5), Control 2 (Day 1), Control 3 (Day 14) and End of Treatment (Day 28). The assessments will be repeated at End of Study (Day 42) after a 14-day follow-up, during which no treatment will be performed. Apart from the Control 1 assessment, all blood samples will be collected at the same time of the day, with a time window of ± 1 hour. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the systemic bioavailability of l-T4 (primary endpoint) and rT3, T3, TSH.; To assess the local and systemic tolerability after repeated cutaneous application of a gel formulation of Somatoline¿.;Timepoint(s) of evaluation of this end point: Blood samples for measurement of TSH concentrations will be collected during the Screening (Day -15 to Day 0), Control 1 (Day 0 ¿ Hour 5), Control 2 (Day 1), Control 3 (Day 14) and End of Treatment (Day 28). The assessments will be repeated at End of Study (Day 42) after a 14-day follow-up, during which no treatment will be performed. Apart from the Control 1 assessment, all blood samples will be collected at the same time of the day, with a time window of ¿ 1 hour.; Safety of the tested formulation will be evaluated based on the record of any AE and SAE. Moreover, the local tolerability at the application site will be assessed by both the investigator (medical visit) and the subject (diary), throughout the entire study duration. | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Cronos Ricerche Cliniche Srl
Outcome results
None listed