DHEP-medicated plaster Not Applicable
Conditions
Interventions
All enrolled subjects received the application of two investigational plasters, one without reinforcement (PW) on one leg (right or left) and one with reinforcement (PRN or PRT), applied concurrently
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Males/females, 18-55 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 6. Contraception and fertility (females only): females of child-bearing potential had to use at least one of the following reliable methods of contraception: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agreed to use a male condom with spermicide 6.4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year were admitted. For all female subjects, pregnancy test result had to be negative at screening and at each scheduled evaluation.
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-leads, supine position): clinically significant abnormalities. 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. 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 could affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study 6. Application site: diseased-skin, skin wounds or open injuries at the applications site 7. Medications: medications, including over the counter medications and herbal remedies, in particular nonsteroidal anti-inflammatory drugs (NSAIDS) and medications containing diclofenac, for 2 weeks before the start of the study. Hormonal contraceptives for females were allowed 8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that followed the last visit of the previous study and the first day of the present study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day) 10. Drug test: positive result at the drug test at screening 11. Alcohol test: positive alcohol breath test at day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean adhesion score for the investigational plaster without reinforcement (PW), derived from the individual adhesion scores representing the highest degree of detachment at each assessment time point averaged across all the equally spaced time points (4, 8, 12, 16, 20 and 24 h post-application) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean adhesion score for the investigational plaster with reinforcement (secured either by elastic net [PRN] or corner taping [PRT]), derived from the individual adhesion scores representing the highest degree of detachment at each assessment time point averaged across all the equally spaced time points (4, 8, 12, 16, 20 and 24 h post-application) 2. Assessment of plaster adhesion as a percentage of total plaster area for PW, PRN and PRT application at 4, 8, 12, 16, 20 and 24 h post-application 3. Proportion of subjects with an adhesion score representing the highest degree of detachment = 2 at any time point for PW, PRN and PRT application (4, 8, 12, 16, 20 and 24 h post-application) 4. Time to an adhesion score = 2 for PW, PRN and PRT application, assessed at 4, 8, 12, 16, 20 and 24 h post-application 5. Frequency of adhesion scores representing the highest degree of detachment at each time point and across all time points for PW, PRN and PRT application (4, 8, 12, 16, 20 and 24 h post-application) 6. Mean adhesion score for both the investigational plaster without reinforcement (PW) and with reinforcement (PRN, PRT), derived from the individual adhesion scores representing the highest degree of detachment at each DAILY assessment time point (4 to 12 h post application) averaged across all the DAILY assessment time points 7. Mean adhesion score for both the investigational plaster without reinforcement (PW) and with reinforcement (PRN, PRT), derived from the individual adhesion scores representing the highest degree of detachment at each NIGHT assessment time point (16 to 24 h post application) averaged across all the NIGHT assessment time points | — |
Countries
Switzerland
Outcome results
None listed