Trial Outcomes & Findings for Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods (NCT NCT06954181)
NCT ID: NCT06954181
Last Updated: 2026-06-16
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Day 1, Day 3 and Day 5
Results posted on
2026-06-16
Participant Flow
The study was conducted at a single center in Germany.
Participant milestones
| Measure |
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.
|
|---|---|
|
Method 1 (1 Day)
STARTED
|
33
|
|
Method 1 (1 Day)
COMPLETED
|
33
|
|
Method 1 (1 Day)
NOT COMPLETED
|
0
|
|
Washout Period 1 (2 Days)
STARTED
|
33
|
|
Washout Period 1 (2 Days)
COMPLETED
|
33
|
|
Washout Period 1 (2 Days)
NOT COMPLETED
|
0
|
|
Method 2 (1 Day)
STARTED
|
33
|
|
Method 2 (1 Day)
COMPLETED
|
33
|
|
Method 2 (1 Day)
NOT COMPLETED
|
0
|
|
Washout Period 2 (2 Days)
STARTED
|
33
|
|
Washout Period 2 (2 Days)
COMPLETED
|
33
|
|
Washout Period 2 (2 Days)
NOT COMPLETED
|
0
|
|
Method 3 (1 Day)
STARTED
|
33
|
|
Method 3 (1 Day)
COMPLETED
|
33
|
|
Method 3 (1 Day)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Method 1/ Method 2/ Method 3 (Single Sequence)
n=33 Participants
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.
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10.9 • n=33 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 3 and Day 5Population: 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.
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).
Outcome measures
| Measure |
Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1: Water 1)
n=31 Participants
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 washing their hands. Water was collected for analysis (Water 1).
|
Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1: Water 2)
n=31 Participants
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).
|
Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2: Water 3)
n=31 Participants
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).
|
Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2: Water 4)
n=31 Participants
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).
|
Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3: Water 5)
n=31 Participants
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).
|
|---|---|---|---|---|---|
|
Concentration of Voltaren® Schmerzgel Forte; 2.32% (Diclofenac) in Water (Milligrams Per Liter [mg/L]) After Washing
|
2.956 mg/L
Standard Deviation 1.853
|
3.156 mg/L
Standard Deviation 1.987
|
3.715 mg/L
Standard Deviation 2.479
|
0.133 mg/L
Standard Deviation 0.097
|
1.506 mg/L
Standard Deviation 0.894
|
PRIMARY outcome
Timeframe: Day 1, Day 3 and Day 5Population: 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.
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.
Outcome measures
| Measure |
Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1: Water 1)
n=31 Participants
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 washing their hands. Water was collected for analysis (Water 1).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|
|
Amount of Test Product Residues by Gravimetrical Measurements (in Gram)
|
0.11 gram
Standard Deviation 0.02
|
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Adverse Events
Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER