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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voltaren® Schmerzgel forte; 2.32% Applied Without Applicator (Method 1) | Experimental | 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. |
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| Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 2) | Experimental | 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. |
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| Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 3) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voltaren® Schmerzgel forte; 2.32% (Test Product) | Drug | Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Schenefeld | 22869 | Germany |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
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.
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.
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The study was conducted at a single center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Method 1/ Method 2/ Method 3 (Single Sequence) | All participants applied the test product (Voltaren® Schmerzgel forte; 2.32 percent [%]) topically on the assigned test area (left or right elbow, depending on the handedness of the participant) using Method 1 on Day 1, followed by Method 2 on Day 3 and Method 3 on Day 5. There was a washout period of at least 2 days between each method. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Method 1 (1 Day) |
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| Washout Period 1 (2 Days) |
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| Method 2 (1 Day) |
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| Washout Period 2 (2 Days) |
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| Method 3 (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Method 1/ Method 2/ Method 3 (Single Sequence) | All participants applied the test product (Voltaren® Schmerzgel forte; 2.32 percent [%]) topically on the assigned test area (left or right elbow, depending on the handedness of the participant) using Method 1 on Day 1, followed by Method 2 on Day 3 and Method 3 on Day 5. There was a washout period of at least 2 days between each method. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Valid participants were defined as enrolled participants who had finished the study without major deviations from the protocol and who had not withdrawn their consent. Valid participants (n=31) as defined above; participants with major protocol deviations excluded. | Posted | Mean | Standard Deviation | mg/L | Day 1, Day 3 and Day 5 |
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From signing of informed consent from until 5 days following last administration of test product (up to approximately 12 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1) | Participants applied 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). Method 1: Participants applied the test product on the assigned test area with one hand by gently massaging in for 60 seconds and washed their hands and 5 minutes after application, washed the test area according to the washing procedure on Days 1, 3 and 5 as per crossover assignment. The water of each washing step was collected separately. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2025 | Apr 10, 2026 | Prot_SAP_000.pdf |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1: Water 2) | Participants applied 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). Method 1: Participants applied the test product on the assigned test area with one hand by gently massaging in for 60 seconds and washed their hands. Water was collected for analysis (Water 1). After 5 minutes of application, participants washed the test area according to the washing procedure. The water was collected for analysis (Water 2). |
| OG002 | Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2: Water 3) | Participants applied 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). Method 2: Participants applied the test product on the assigned test area with the applicator, followed by washing the test area 5 minutes after application. Water was collected for analysis (Water 3). |
| OG003 | Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2: Water 4) | Participants applied 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). Method 2: Participants applied the test product on the assigned test area with the applicator, followed by washing the test area 5 minutes after application. The water was collected for analysis (Water 3). After 5 minutes, participants washed the same test area again according to the washing procedure. The water was collected for analysis (Water 4). |
| OG004 | Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3: Water 5) | Participants applied 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). Method 3: Participants applied the test product on the assigned test area with the applicator. After 5 minutes, site of application and hands were wiped using paper towel and then washed. The water was collected for analysis (Water 5). |
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| Primary | 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. | Valid participants were defined as enrolled participants who had finished the study without major deviations from the protocol and who had not withdrawn their consent. Valid participants (n=31) as defined above; participants with major protocol deviations excluded. | Posted | Mean | Standard Deviation | gram | Day 1, Day 3 and Day 5 |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2) | Participants applied 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). Method 2: Participants applied 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 was collected separately. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3) | Participants applied 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). Method 3: Participants applied 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 was collected. | 0 | 33 | 0 | 33 | 0 | 33 |
HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.