Healthy ParticipantsNCT06954181
Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
A study testing Voltaren® Schmerzgel forte; 2.32% (Test Product) in people with Healthy Participants, run by HALEON at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Voltaren® Schmerzgel forte; 2.32% (Test Product)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2025to 11 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Voltaren® Schmerzgel forte; 2.32% (Test Product)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voltaren® Schmerzgel forte; 2.32% (Test Product)Drug
Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product) |
| 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. Receives: Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product) |
| 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. Receives: Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1, Day 3 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start26 Mar 2025
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954181
- Sponsor's protocol ID
- 300272
- Status last verified
- May 2026
- First submitted
- 24 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
- ClinicalTrials.gov ID
- NCT06954181
- Acronym / sponsor ID
- 300272
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Voltaren® Schmerzgel forte; 2.32% Applied Without Applicator (Method 1) | Experimental | Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product)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. |
| Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 2) | Experimental | Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product)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. |
| Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 3) | Experimental | Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voltaren® Schmerzgel forte; 2.32% (Test Product)Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin. | Drug | Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 2), Voltaren® Schmerzgel forte; 2.32% Applied With Applicator (Method 3), Voltaren® Schmerzgel forte; 2.32% Applied Without Applicator (Method 1) |
Primary outcome
Concentration of Voltaren® Schmerzgel Forte; 2.32% (Diclofenac) in Water (Milligrams Per Liter [mg/L]) After Washing
Time frame: Day 1, Day 3 and Day 5
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).
Amount of Test Product Residues by Gravimetrical Measurements (in Gram)
Time frame: Day 1, Day 3 and Day 5
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voltaren® Schmerzgel forte; 2.32% (Test Product) in people with Healthy Participants, run by HALEON at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Voltaren® Schmerzgel Forte; 2.32% (Diclofenac) in Water (Milligrams Per Liter [mg/L]) After Washing (time frame: Day 1, Day 3 and Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.