NCT06954181

Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to quantify the amount of diclofenac in rinse water after application of the test product (Voltaren® Schmerzgel forte; 2.32 percent \[%\]) containing 2.32% Diclofenac-N-Ethylethanamin either by hand or using an applicator and subsequent washing and/or wiping.

Detailed description

This will be an exploratory, open label, crossover study. Participants with healthy skin on the elbows and hands will be enrolled. The amount of diclofenac in rinse water after application of the test product (Voltaren® Schmerzgel forte; 2.32%) containing 2.32% Diclofenac-N-Ethylethanamin will be assessed after three different washing methods, with and without use of an applicator in a crossover design. There will be a wash-out period of at least 2 days in between each method. Approximately 40 participants will be enrolled in this study.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Voltaren® Schmerzgel forte; 2.32% (Test Product)	Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2025-05-01
• Last updated: 2025-05-01

Locations

1 site across 1 country: Germany