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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product)

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany, 22869
    • SGS proderm GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.
• Female and/or male.
• From 18 to 70 years of age.

Exclusion Criteria:

• Female participants: Pregnancy or lactation.
• Drug addicts, alcoholics.
• Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV)-positive or infectious hepatitis.
• Conditions which exclude a participation or might influence the test reaction/evaluation.
• Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
• Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
• A previous allergic reaction, sensitivity or intolerance to diclofenac or any of the other ingredients in Voltaren® Schmerzgel forte.
• Participants in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetyl salicylic acid or other non-steroidal anti-inflammatory drugs (example, ibuprofen, naproxen et cetera).
• Documented allergies to cosmetic products.
• Active skin disease at the test area.
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, et cetera, at the test area that could influence the investigation.
• Any topical medication at the test area within the last 3 days prior to the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voltaren® Schmerzgel forte; 2.32% Applied Without Applicator (Method 1); Participants will apply the test product (Voltaren® Schmerzgel forte; 2.32%) topically on the assigned test area (left or right elbow, depending on the handedness of the participant) using 3 different methods, once on Days 1, 3 and 5 as per crossover assignment. There will be a washout period of at least 2 days between each method. Method 1: Participants will apply the test product on the assigned test area with one hand by gently massaging in for 60 seconds and will wash their hands and 5 minutes after application, will wash the test area according to the washing procedure on Days 1, 3 and 5 as per crossover assignment. The water of each washing step will be collected separately.	Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product); Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.
Experimental: Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 2); Participants will apply the test product (Voltaren® Schmerzgel forte; 2.32%) topically on the assigned test area (left or right elbow, depending on the handedness of the participant) using 3 different methods, once on Days 1, 3 and 5 as per crossover assignment. There will be a washout period of at least 2 days between each method. Method 2: Participants will apply the test product on the assigned test area with the applicator, followed by washing the test area 5 minutes after application (1st washing) and 5 minutes after 1st washing (2nd washing) on Days 1, 3 and 5 as per crossover assignment. The water of each washing step will be collected separately.	Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product); Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.
Experimental: Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 3); Participants will apply the test product (Voltaren® Schmerzgel forte; 2.32%) topically on the assigned test area (left or right elbow, depending on the handedness of the participant) using 3 different methods, once on Days 1, 3 and 5 as per crossover assignment. There will be a washout period of at least 2 days between each method. Method 3: Participants will apply the test product on the assigned test area with the applicator followed by wiping the test area with a paper towel and washing the test area and hands according to the washing procedure after 5 minutes of application on Days 1, 3 and 5 as per crossover assignment. The water of the washing step will be collected.	Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product); Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Voltaren® Schmerzgel Forte; 2.32% (Diclofenac) in Water (Milligrams Per Liter [mg/L]) After Washing	The concentration of diclofenac in rinse water samples (mg/L) collected after application of the test product (Voltaren® Schmerzgel forte; 2.32%) was determined with High-performance liquid chromatography (HPLC).	Day 1, Day 3 and Day 5
Amount of Test Product Residues by Gravimetrical Measurements (in Gram)	Test product (Voltaren® Schmerzgel forte; 2.32%) residue was collected using Method 3 (application of the test product using an applicator and subsequent wiping with a paper towel). The paper towels were weighed before and after wiping the test area. The amount of test product residue (gram) in paper towel= The weight of paper towel after product application minus weight of paper towel before product application.	Day 1, Day 3 and Day 5

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): April 11, 2025
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 300272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No