Plain English Summary
Background and study aims
In a previous study conducted with healthy volunteers, the DHEP-Heparin medicated plaster was applied to the front thigh, reinforced using a loose fitting elastic net sleeve, and investigated under three non-standard treatment conditions (moderate exercise, under occlusion, and moderate heat exposure) in comparison to the reference condition of rest without occlusion. The results showed that all plasters under all four conditions adhered to at least 75% of the application area. All plasters adhered for ≥ 90% of the application area for most participants during moderate exercise and under occlusion. The aim of this study is to assess the adhesion of the DHEP-Heparin medicated plaster for the intended wear period of 24 hours.
Who can participate?
Healthy volunteers aged 18-55
What does the study involve ?
Participants are treated with two DHEP-Heparin medicated plasters on the lower part of the right and left leg. One plaster is applied without reinforcement and one plaster is applied with reinforcement with either elastic net or corner taping. Adhesion of the plasters is assessed after 4, 8, 12, 16, 20 and 24 hours.
What are the possible benefits and risk of partecipating ?
No specific benefits for the participants are foreseen. The application of two DHEP-Heparin plasters is considered to be safe.
Where is the study run from?
CROSS Research Phase I Unit (Switzerland)
When is the study starting and how long is it expected to run for?
December 2016 to February 2017
Who is funding the study?
IBSA Institut Biochimique SA (Switzerland)
Who is the main contact?
Dr Milko Radicioni
Trial website
Contact information
Type
Scientific
Primary contact
Dr Milko Radicioni
ORCID ID
http://orcid.org/0000-0002-3940-8375
Contact details
CROSS Research S.A. – Phase I Unit
Via F.A. Giorgioli 14
Arzo
CH-6864
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study CRO-PK-17-317 - Sponsor code 17CH/FHp01
Study information
Scientific title
Adhesion study of Flectoparin® Tissugel following plaster application to the lower leg (supra-malleolar area) in healthy volunteers
Acronym
Study hypothesis
Assess DHEP-Heparin medicated plaster (Flectoparin® Tissugel) adhesion to the skin at multiple adhesion time points up to 24 h following lower part of the leg application in healthy men and women.
Ethics approval
Comitato Etico Cantonale, Canton Ticino, Switzerland,09/02/2017, ref: CE3172, BASEC (Business Administration System for Ethics Committee) Nr. 2017-00193
Study design
Single-centre single-dose one-period randomised adhesion assessment study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
DHEP-medicated plaster
Intervention
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 to the lower part of the leg just above the malleolus. Half of the plasters for PR treatment were reinforced with an elastic net (PRN) and half with four 7 cm long tapes applied to the four corners of the medicated plaster (PRT). The randomisation list was computer-generated by the Department of Biometry at the Contract Research Organization (CRO) using the PLAN procedure of SAS Version 9.3, and supplied to the study site prior to study start. Investigational plasters were applied in the morning (08:00±1 h) and kept in place for 24 h.
Intervention type
Drug
Phase
Phase I
Drug names
Diclofenac-N-(2hydroxyethyl)-pyrrolidine (DHEP) medicated plaster formulated with heparin (Flectoparin® Tissugel, IBSA, Switzerland)
Primary outcome measures
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 outcome measures
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
Overall trial start date
20/12/2016
Overall trial end date
28/02/2017
Reason abandoned
Eligibility
Participant 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.
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Twenty-eight (28) subjects were enrolled in the study as planned
Participant 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 (<1600 or >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
Recruitment start date
21/02/2017
Recruitment end date
28/02/2017
Locations
Countries of recruitment
Switzerland
Trial participating centre
CROSS Research Phase I Unit
Via F. A. Giorgioli 14
Arzo
6864
Funders
Funder type
Government
Funder name
IBSA Institut Biochimique SA
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository.
Intention to publish date
28/02/2018
Participant level data
Stored in repository
Results - basic reporting
Publication summary