Evaluation of Diclofenac Skin Reservoir Formation and Depletion Following Topical Application in Healthy Volunteers

The primary objective is to evaluate the formation and emptying of a diclofenac skin reservoir following the application of Voltaren Emulgel 2.32%. This assessment is clinically relevant for understanding the pharmacokinetics of topical non-steroidal anti-inflammatory drugs used for the local, symptomatic treatment of pain associated with acute bruises, strains, or sprains resulting from blunt trauma.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants fall within the age ranges corresponding to codes 3 and 4. The study focuses on individuals experiencing acute bruises, strains, or sprains resulting from blunt trauma.

This Phase 3 clinical trial utilizes a design to investigate diclofenac skin reservoir formation and emptying following the application of Voltaren Emulgel 2.32% in healthy participants. The research methodology focuses on assessing the pharmacological behavior of the topical formulation used for the local, symptomatic treatment of pain associated with acute bruises, strains, or sprains resulting from blunt trauma. The study protocol includes a screening visit to determine eligibility, followed by scheduled study visits to monitor the physiological processes of the medication. An end-of-study visit is conducted to complete the data collection. The total duration of the study is estimated to occur between May 2026 and July 2026. Participant involvement may be subject to early termination based on predefined clinical criteria or safety protocols.

The assessment of efficacy focuses on the local, symptomatic treatment of pain resulting from acute bruises, strains, or sprains caused by blunt trauma, such as sports or accident-related injuries.