Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT02221726|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: JNJ-35684-AAA-023: Size 1; small patch Drug: JNJ-35684-AAA-023: Size 2; large patch||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
|Experimental: JNJ-35684-AAA-023: 5.5 cm^2 Patch||
Drug: JNJ-35684-AAA-023: Size 1; small patch
Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.
|Experimental: JNJ-35684-AAA-023: 44 cm^2 Patch||
Drug: JNJ-35684-AAA-023: Size 2; large patch
Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
- Visual Grading United States Food and Drug Administration (FDA) Scale Score [ Time Frame: Baseline up to 72 hours following patch application ]Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system. The score ranges from 0-4: 0 = greater than or equal to (>=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (<) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to <75% adhered (less than half of the patch lifting off the skin); 3 = greater than (>) 0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).
- Adhesion Area Calculated by Digital Image Analysis [ Time Frame: Baseline up to 72 hours following patch application ]Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.
- Total Adhesion Score Calculated by Visual Grading Grid System [ Time Frame: Baseline up to 72 hours following patch application ]Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin. Total area of the patch which does not adhere will be calculated. Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area. Subsequently, a total adhesion score for that system will be calculated.
- Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Baseline up to 72 hours following patch application ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221726
|United States, California|
|Cypress, California, United States|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|