Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 11/8/2014 |
Start Date: | August 2014 |
End Date: | August 2014 |
Email: | JNJ.CT@sylogent.com |
Evaluation of Scoring Methods to Assess Adhesion Quality and Wear of the Placebo JNJ-35685-AAA-G-023 5.5 cm^2 and 44 cm^2 Transdermal Systems
The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive
quality of placebo (an inactive substance that is compared with a drug to test whether the
drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the
skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch
sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).
quality of placebo (an inactive substance that is compared with a drug to test whether the
drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the
skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch
sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).
This study will assess 3 different scoring systems to evaluate the adhesive quality of
"placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G
transdermal (through the skin) system. In this study, this patch is NOT being compared to a
patch with a drug, and is NOT being used to test if the patch with the drug has a real
effect in a clinical trial. The study consists 3 parts: Screening (21 days before study
commences on Day 1), an adhesion assessment period (4 days), and an end of Study (EOS)
assessment (recorded at 24 hours +/- 4 hours following patch removal). Total study duration
per participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2)
and large (44 cm^2) patches will be applied on to left or right side of the paraspinal
region based on randomization schedule. Adhesion assessments will be performed at patch
application (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and
72 hours following patch application. Adhesion quality will be assessed by visual grading,
United States Food and Drug Administration (FDA) scale, digital image analysis and visual
grading grid system. Participants' safety will be monitored throughout the study.
"placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G
transdermal (through the skin) system. In this study, this patch is NOT being compared to a
patch with a drug, and is NOT being used to test if the patch with the drug has a real
effect in a clinical trial. The study consists 3 parts: Screening (21 days before study
commences on Day 1), an adhesion assessment period (4 days), and an end of Study (EOS)
assessment (recorded at 24 hours +/- 4 hours following patch removal). Total study duration
per participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2)
and large (44 cm^2) patches will be applied on to left or right side of the paraspinal
region based on randomization schedule. Adhesion assessments will be performed at patch
application (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and
72 hours following patch application. Adhesion quality will be assessed by visual grading,
United States Food and Drug Administration (FDA) scale, digital image analysis and visual
grading grid system. Participants' safety will be monitored throughout the study.
Inclusion Criteria:
- Body mass index (BMI: weight in kilogram [kg]/height^2 [meter (m^2)]) between 18 and
35 kg/m^2 (inclusive), and body weight not less than 50 kg
- Blood pressure (can be taken in supine or sitting position) between 90 and 140
milimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker (for at least 6 months prior to screening) and willing to abstain from
smoking during the study confinement period
- Good general health as determined by medical history, physical examination,
electrocardiogram (ECG) and clinical laboratory tests
- Willing to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- History of or current clinically significant medical illness including but not
limited to, cardiac arrhythmias or other cardiac disease; hematologic disease;
coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid
abnormalities; significant pulmonary disease, including bronchospastic respiratory
disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance
below 60 milliliter per minute [mL/min]); thyroid disease; neurologic or psychiatric
disease; infection; or any other illness that the Investigator considers should
exclude the subject or that could interfere with the interpretation of the study
results
- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at screening as deemed appropriate by the Investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at
screening as deemed appropriate by the Investigator
- Use of medications or treatments that would significantly influence or exaggerate
patch adhesion or that would alter inflammatory or immune response to the study
product (example, antihistamines, systemic or topical corticosteroids, cyclosporine,
tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG),
monoclonal antibodies, radiation therapy)
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of
Mental Disorders (4th edition) criteria within 5 years before screening or positive
test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates,
cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening
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