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NCT02727205 · ClinicalTrials.gov registry record · Phase 1
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
A Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, sponsored by Inflamax Research Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
- 2
- Study locations
NCT02727205: Completed Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, sponsored by Inflamax Research Incorporated.
NCT02727205 is a Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch that has completed, run by Inflamax Research Incorporated. The registered enrollment target is 260 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02727205, a Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, has completed, sponsored by Inflamax Research Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
- 2
- Study locations
Study 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 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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Rotigotine Transdermal System
Study Locations (2)
Florida
- Clinical Pharmacology of Miami, Inc. - Miami
Ontario
- Inflamax Research Inc. - Mississauga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT02727205 record still lists
NCT02727205 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher).
The record links to 1 condition, with Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch appearing as the primary indexed condition, and to 1 intervention - of which Rotigotine Transdermal System is the first listed.
NCT02727205 reports a single indexed study location in Florida, Ontario.
Frequently Asked Questions
What is clinical trial NCT02727205 about?
NCT02727205 is a clinical study titled "Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch". 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...
What is the current status of trial NCT02727205?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2013-08. Estimated completion is 2013-10.
What conditions does trial NCT02727205 study?
This clinical trial studies the following conditions: Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch.
What interventions are being tested in trial NCT02727205?
The interventions under investigation include: Rotigotine Transdermal System (DRUG).
Who is sponsoring clinical trial NCT02727205?
This trial is sponsored by Inflamax Research Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02727205 being conducted?
This trial has 2 study locations across Florida, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02727205's enrollment target sits among peer trials
260 160th of 2000 higher than 1,834 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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