Bioequivalence - Irritation and Sensitization Potential of Transdermal PatchPhase 1NCT02727205
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
A Phase 1 study testing Rotigotine Transdermal System in people with Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, run by Inflamax Research Incorporated at 2 sites in 2 countries.
Trial summary
STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers TEST DRUG / INVESTIGATIONAL PRODUCT: Rotigotine Transdermal System, 1 mg/24 hr… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch
- What is being tested?
- Rotigotine Transdermal System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2013to Oct 2013
- 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
- Healthy male and non-pregnant female volunteers. All subjects were healthy, non-smoking male and female (nonpregnant) volunteers between the ages of 18 and 65, who were demonstrated to be generally healthy by screening medical and medication history, physical examinations, vital signs, 12-lead electrocardiogram (ECG), and FSH levels (if applicable).
Who cannot join
- Reported receiving any investigational drug within 30 days prior to Day 1 patch application.
- Reported a clinically significant illness during the 28 days prior to Day 1 patch application (as determined by the Investigator[s]).
- Reported a history of allergic response(s) to rotigotine or related drugs.
- Reported a history of sulfite sensitivity.
- Demonstrated a clinically relevant finding, as determined by the clinical Investigator(s), on the screening ECG, such as a second- or third-degree atrioventricular block or complete bundle branch block, or arrhythmias.
- Reported a history of asthma, orthostatic hypotension, dizziness, syncope, or dyskinesia. At the discretion of the Principal Investigator, subjects with a history of asthma or mild asthma not requiring regular treatment could have been included.
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- Systolic blood pressure < 100 or >145 mmHg or diastolic blood pressure < 60 or > 95 mmHg at screening measured in supine position after 5 minutes rest; heart rate < 50 or > 100 at screening.
- Reported a history of narrow angle glaucoma.
- Reported the use of monoamine oxidase (MAO) inhibitors, reserpine, methyldopa, antipsychotics, neuroleptics, benzodiazepines, antidepressants, clozapine, olanzapine, quetiapine, metoclopramide, or risperidone within 3 months of enrollment.
- Reported a history of somnolence and/or of falling asleep without warning.
- Reported a history of significant dermatologic diseases or conditions such as atopy, or psoriasis.
- Reported a history of medical conditions known to alter skin appearance or physiologic response (eg diabetes, porphyria).
- Reported a history of significant dermatologic cancers (eg melanoma, squamous cell carcinoma). Basal cell carcinomas that were superficial and did not involve the investigative sites were acceptable.
- Reported a history of conditions that would significantly influence the immune response (e.g. primary or acquired immunodeficiencies such as HIV positive or AIDS, or generalized drug reaction, neoplasms such as lymphoma or leukemia, moderate or severe rheumatoid arthritis or active systemic lupus erythematosus).
- Demonstrated an obvious difference in skin color amongst application sites, presence of a skin condition, excessive hair (subjects that agreed to have their hair clipped short [not shaved] prior to patch application were eligible), scar tissue, recent sunburn, tattoo, open sore, body piercing, or branding at the intended sites of application that would interfere with placement of study articles, skin assessment or reactions to drug.
- Reported the use of any immunosuppressive drugs, including systemic and topical corticosteroids and retinoids within 28 days prior to Day 1 patch application.
- Reported the use of any medications or treatments that would significantly influence or exaggerate responses to the patches or that would alter inflammatory or immune responses to the patches within 21 days prior to Day 1 patch application (e.g. cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, radiation therapy).
- Reported the use of any anti-inflammatory medication, including ibuprofen and Celebrex, within 72 hours of Day 1 patch application, with the exception of steroid nose drops and/or eye drops.
- Reported the use of antihistamines or topical drugs at the patch site within 72 hours of Day 1 patch application.
- Reported a history of anaphylactic reaction to drugs. At the discretion of the Investigator, subjects with seasonal allergic rhinitis with sensitivity to environmental allergens could have been included.
- Reported a history of sensitivity or allergy to adhesive bandages, tapes, or transdermal systems.
- Reported a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
- Reported a history of drug or alcohol addiction or abuse within the past year.
- Was pregnant, lactating, breastfeeding, or intended to become pregnant over the course of the study (females only).
- Demonstrated a positive pregnancy screen (females only). Subjects with a positive result at screening were to be excluded from the study. Subjects with a positive result during the study were to be withdrawn.
- Reported smoking or using tobacco products or was currently using nicotine products (patches, gums, etc.). Ninety (90) days abstinence was required.
- Reported a plan to undergo magnetic resonance imaging or cardioversion procedures during the study period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
About this study
Official title: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers
STUDY TITLE:
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers
TEST DRUG / INVESTIGATIONAL PRODUCT:
Rotigotine Transdermal System, 1 mg/24 hr
INDICATION STUDIED:
Bioequivalence - Irritation and Sensitization
STUDY DESIGN:
- Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study
- One-half (½) of the test patch and one-half (½) of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase
- Being tested
- Rotigotine Transdermal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine Transdermal SystemDrug
Also called Neupro
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | One-half (½) of the test patch and one-half (½) of the reference patch (Rotigotine Transdermal System) was applied daily to the same site for each product over a 21 day period followed by a 14 day rest phase and a 48 hour challenge phase. Receives: Drug: Rotigotine Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation
The primary endpoint of cumulative irritation was the measurement of the combined "Dermal response" and "Other Effect" total irritation scores recorded during the 21 day continuous application period (i.e. the total irritation score for a specific subject was the sum of the irritation scores recorded on Days 2 through 22 for each patch type). Because the cumulative irritation scores did not display a normal distribution, the primary analysis was a comparison of the overall median of the observed total irritation score of the Test patch against the Reference patch. The Per Protocol Population for Irritation (PPPI) was used for the primary analysis
Measured: 21 days (Induction Phase)
Sensitization
The primary analysis of sensitization used the Per Protocol Population for Sensitization (PPPS) and compared the number and percentage (%) of reactions indicating potential sensitization (irritation score greater than or equal to 2 at 48 or 72 hours post-removal, along with the Investigator's assessment) observed with each patch type
Measured: 48 and 72 hour post removal of patch after the challenge phase.
Secondary outcomes (1)
Adhesion
Adhesion scores
Measured: 21 days (Induction Phase) and 1 day Sensitization Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence - Irritation and Sensitization Potential of Transdermal PatchStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflamax Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Piyush Patel, MD, Inflamax Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727205
- Sponsor's protocol ID
- AC13GP01
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02727205
- Acronym / sponsor ID
- AC13GP01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Inflamax Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Apr 2016 (estimated)
- 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.
STUDY TITLE:
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers
TEST DRUG / INVESTIGATIONAL PRODUCT:
Rotigotine Transdermal System, 1 mg/24 hr
INDICATION STUDIED:
Bioequivalence - Irritation and Sensitization
STUDY DESIGN:
- Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study
- One-half (½) of the test patch and one-half (½) of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Rotigotine Transdermal SystemOne-half (½) of the test patch and one-half (½) of the reference patch (Rotigotine Transdermal System) was applied daily to the same site for each product over a 21 day period followed by a 14 day rest phase and a 48 hour challenge phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and non-pregnant female volunteers. All subjects were healthy, non-smoking male and female (nonpregnant) volunteers between the ages of 18 and 65, who were demonstrated to be generally healthy by screening medical and medication history, physical examinations, vital signs, 12-lead electrocardiogram (ECG), and FSH levels (if applicable).
Key exclusion criteria (27 listed)
- Reported receiving any investigational drug within 30 days prior to Day 1 patch application.
- Reported a clinically significant illness during the 28 days prior to Day 1 patch application (as determined by the Investigator[s]).
- Reported a history of allergic response(s) to rotigotine or related drugs.
- Reported a history of sulfite sensitivity.
- Demonstrated a clinically relevant finding, as determined by the clinical Investigator(s), on the screening ECG, such as a second- or third-degree atrioventricular block or complete bundle branch block, or arrhythmias.
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 |
|---|---|---|
| Rotigotine Transdermal SystemAlso: Neupro | Drug | Single Arm |
Primary outcome
Irritation
Time frame: 21 days (Induction Phase)
The primary endpoint of cumulative irritation was the measurement of the combined "Dermal response" and "Other Effect" total irritation scores recorded during the 21 day continuous application period (i.e. the total irritation score for a specific subject was the sum of the irritation scores recorded on Days 2 through 22 for each patch type). Because the cumulative irritation scores did not display a normal distribution, the primary analysis was a comparison of the overall median of the observed total irritation score of the Test patch against the Reference patch. The Per Protocol Population for Irritation (PPPI) was used for the primary analysis
Sensitization
Time frame: 48 and 72 hour post removal of patch after the challenge phase.
The primary analysis of sensitization used the Per Protocol Population for Sensitization (PPPS) and compared the number and percentage (%) of reactions indicating potential sensitization (irritation score greater than or equal to 2 at 48 or 72 hours post-removal, along with the Investigator's assessment) observed with each patch type
1 secondary outcome
Adhesion
Time frame: 21 days (Induction Phase) and 1 day Sensitization Phase
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 4 Apr 2016.
- Individual participant dataSharing planned: No
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rotigotine Transdermal System in people with Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, run by Inflamax Research Incorporated at 2 sites in 2 countries.
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 1 inclusion and 27 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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. 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?
Irritation (time frame: 21 days (Induction Phase)). 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 4 Apr 2016.