HealthyPhase 1NCT03639571
Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
A Phase 1 study testing Ibuprofen 200 mg TEPI Medicated Plaster in people with Healthy, run by Medherant Ltd at 1 site in Bulgaria.
Trial summary
This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases: Induction Phase: multiple dose application of one active and one placebo plaster on 5… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen 200 mg TEPI Medicated Plaster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBulgaria
- Study dates
- 9 Aug 2018to 25 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subject
- Age between 18 and 65 years
- Physically and mentally healthy as judged by means of medical and standard laboratory examinations
- Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year*) and non-users of other nicotine containing products, confirmed by urine cotinine test
- Weight ≥ 60 kg and BMI within the range (including the borders) of 18.0 to 30.0 kg/m2
- Informed consent given in written form.
Who cannot join
- Participation in another clinical trial at same time or within the preceding 90 days (calculated from the date of the final examination of the previous study)
- Fertile women without reliable contraception method. List of allowed medically accepted contraceptive methods and the allowed HRT (used at least 4 weeks prior entry visit and not to be changed for the duration of the study):
- combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
- intrauterine devices (IUD): inert or copper-releasing or progestinreleasing IUD
- hormonal methods: combined oestrogen/progestin injectable contraceptives, progestin only injectable contraceptives, Norplant implants, skin patches, NuvaRing®
- Hormone Replacement Therapy (HRT)
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- voluntary sterilization (female tubal occlusion).
- Randomisation into the present trial more than once
- History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
- Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
- Positive drug screening and/or positive alcohol test at entry (screening) visit, or on Day -1, or on Day 19
- Pregnant and/or nursing women. Positive pregnancy test at entry (screening) visit, or on Day -1, or on Day 19
- Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyper-reactivity, contact dermatitis)
- Known allergy to sticking plaster or to the ingredients of the products
- Dermatologic disease that might interfere with the evaluation of test site reaction
- Active skin disease
- Subjects with tattoos, sunburn, coloration, open sores or scars on site of application
- Subject with excessive hair at site of plaster application
- Intake of systemic drugs interfering with the immune system (e.g. antiinflammatories, corticosteroids, immune-suppressants or antihistamines) within 2 weeks before and during the study
- Topical therapy with analgesics or corticosteroids or antihistamines at the application sites within 2 weeks before and during the study
- Intake or administration of any systemic or topical medication (including prescribed medication, OTC medication, and especially use of ointments, gels or patches for skin application) within 2 weeks before entry (screening) visit and during the study
- Use of topical products without medication at the application sites (including make-up, sunscreen, creams, lotions, powders, alcohol) from 7 days prior entry (screening) visit and during the study
- Intensive UV-light exposure (sunbath) at the application sites within 2 weeks before entry (screening) visit and during the study
- Use of tanning beds at the application sites within 2 weeks before entry (screening) visit and during the study
- Any method of hair removal (e.g. waxing, shaving, epilating, laser) at the application sites from 7 days before entry (screening) visit and during the study
- Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other diseases (e.g. autoimmune disorders such as lupus erythematosus)
- Clinically significant illness within 4 weeks before entry (screening) visit and during the study
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies [
- Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg12 at entry (screening) visit
- Heart rate outside the range of 50 to 90 beats/min at entry (screening) visit
- Respiratory rate outside the range of 12-24 breaths/min at entry (screening) visit
- Axillary body temperature outside the interval of 35.5 to 37.1°C at entry (screening) visit
- Any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
- Laboratory values outside normal range with clinical relevance at entry (screening) examination
- Not fulfilling study specific restrictions and diet
- Subjects who are known or suspected:
- not to comply with the study directives
- not to be reliable or trustworthy
- not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the inconvenience they may be involved in
- subject is a dependent person, e.g. a relative, family member, or member of the investigator's or sponsor's staff
- subject is in custody or submitted to an institution due to a judicial order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-period, Multiple and Single Dose, Randomised, Double-blind, Placebo-controlled, Healthy Volunteer, Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases:
Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.
- Conditions
- Healthy
- Being tested
- Ibuprofen 200 mg TEPI Medicated Plaster, Placebo TEPI Plaster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 200 mg TEPI Medicated PlasterDrug
Ibuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK
Placebo TEPI PlasterOther
Placebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Ibuprofen 200mg TEPI medicated plaster Receives: Drug: Ibuprofen 200 mg TEPI Medicated Plaster |
| Placebo | Placebo comparator | Placebo TEPI Plaster Receives: Other: Placebo TEPI Plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Irritation Score
Average of Dermal Response Scores Score Definition 0 - No evidence of irritation
- - Minimal erythema, barely perceptible
- - Definite erythema, readily visible; minimal oedema or minimal papular response
- - Erythema and papules
- - Definite oedema
- - Erythema, oedema, and papules
- - Vesicular eruption
- - Strong reaction spreading beyond test site
Measured: 10 days
Total Cumulative Irritation Score
Sum of Dermal Response Scores - Score Definition 0 - No evidence of irritation
- - Minimal erythema, barely perceptible
- - Definite erythema, readily visible; minimal oedema or minimal papular response
- - Erythema and papules
- - Definite oedema
- - Erythema, oedema, and papules
- - Vesicular eruption
- - Strong reaction spreading beyond test site
Measured: 10 dyas
Secondary outcomes (3)
Mean Combined Dermal Response Score
Average of Dermal Response + Other Effects Score Dermal score - as explained above other effect score - Score Definition 0 - None observed
- - Slight glazed appearance
- - Marked glazing
- - Glazing with peeling and cracking
- - Glazing with fissures Film of dried serous exudates covering all or part of the plaster site Small petechial erosions and/or scabs
Measured: 10 days
Total Combined Dermal Response Score
Sum of Dermal Response Score and Other Effects Score Dermal Response score - As explained above Other effects score - As explained above
Measured: 10 days
Combined Dermal Response Scores
Combined Dermal Response Scores ≥2 Dermal response score - As explained above other effects score - as explained above
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start9 Aug 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medherant Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cooperative Clinical Drug Research and Development AG (CCDRD AG)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639571
- Sponsor's protocol ID
- MED-IBU-102
- Status last verified
- Apr 2019
- First submitted
- 16 Aug 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-period, Multiple and Single Dose, Randomised, Double-blind, Placebo-controlled, Healthy Volunteer, Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
- ClinicalTrials.gov ID
- NCT03639571
- Acronym / sponsor ID
- MED-IBU-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medherant LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cooperative Clinical Drug Research and Development AG (CCDRD AG)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases:
Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Ibuprofen 200 mg TEPI Medicated PlasterIbuprofen 200mg TEPI medicated plaster |
| Placebo | Placebo comparator | Other: Placebo TEPI PlasterPlacebo TEPI Plaster |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subject
- Age between 18 and 65 years
- Physically and mentally healthy as judged by means of medical and standard laboratory examinations
- Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year*) and non-users of other nicotine containing products, confirmed by urine cotinine test
- Weight ≥ 60 kg and BMI within the range (including the borders) of 18.0 to 30.0 kg/m2
Key exclusion criteria (42 listed)
- Participation in another clinical trial at same time or within the preceding 90 days (calculated from the date of the final examination of the previous study)
- Fertile women without reliable contraception method. List of allowed medically accepted contraceptive methods and the allowed HRT (used at least 4 weeks prior entry visit and not to be changed for the duration of the study):
- combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
- intrauterine devices (IUD): inert or copper-releasing or progestinreleasing IUD
- hormonal methods: combined oestrogen/progestin injectable contraceptives, progestin only injectable contraceptives, Norplant implants, skin patches, NuvaRing®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 200 mg TEPI Medicated PlasterIbuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK | Drug | Test |
| Placebo TEPI PlasterPlacebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK | Other | Placebo |
Primary outcome
Mean Irritation Score
Time frame: 10 days
Average of Dermal Response Scores Score Definition 0 - No evidence of irritation 1. - Minimal erythema, barely perceptible 2. - Definite erythema, readily visible; minimal oedema or minimal papular response 3. - Erythema and papules 4. - Definite oedema 5. - Erythema, oedema, and papules 6. - Vesicular eruption 7. - Strong reaction spreading beyond test site
Total Cumulative Irritation Score
Time frame: 10 dyas
Sum of Dermal Response Scores - Score Definition 0 - No evidence of irritation 1. - Minimal erythema, barely perceptible 2. - Definite erythema, readily visible; minimal oedema or minimal papular response 3. - Erythema and papules 4. - Definite oedema 5. - Erythema, oedema, and papules 6. - Vesicular eruption 7. - Strong reaction spreading beyond test site
3 secondary outcomes
Mean Combined Dermal Response Score
Time frame: 10 days
Total Combined Dermal Response Score
Time frame: 10 days
Combined Dermal Response Scores
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen 200 mg TEPI Medicated Plaster in people with Healthy, run by Medherant Ltd at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Irritation Score (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.