Open‑Label Evaluation of Adhesion Performance of an Esflurbiprofen Transdermal Patch in Healthy Volunteers
- Trial ID
- 2025-523577-42-00
- Protocol
- TK-254RX-0107
- Sponsor
- Teikoku Seiyaku Co. Ltd.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this open‑label study is to evaluate the patch adhesion performance of an Esflurbiprofen‑containing transdermal system in healthy volunteers, assessing the durability and consistency of attachment over the specified wear period to determine its suitability for clinical use. No secondary objectives were specified in the source information.
Participants
The trial enrolled healthy volunteers of both sexes, and inclusion of vulnerable individuals was permitted; however, the sponsor did not provide the total number of participants. The specific age range for enrolment was not disclosed, and no detailed lifestyle criteria such as diet or physical activity were reported. Selection of participants was based on their status as healthy individuals, without further description of additional inclusion or exclusion parameters.
Plans and Procedures
The study is a phase 3, open label trial enrolling healthy volunteers to evaluate patch adhesion of an esflurbiprofen‑containing transdermal system. Participants undergo a screening visit to confirm eligibility, followed by a baseline visit in which the patch is applied and baseline adhesion measurements are recorded. Subsequent follow‑up visits are scheduled at predetermined intervals to monitor patch adherence, collect safety observations, and assess any skin reactions. The final visit serves as the end‑of‑study assessment, documenting overall adhesion performance and completing study procedures. Participant involvement extends from the screening appointment through the end‑of‑study visit, encompassing the entire trial period from January 1 2026 to March 30 2026. Early termination may occur if a participant experiences a serious adverse event, displays non‑compliance with study requirements, or withdraws consent at any time.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Germany | Not Recruiting | 01 Jan 2026 | 90 |

