Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
- Conditions
- Healthy Participants
- Interventions
- Drug: Voltaren® Schmerzgel forte; 2.32% (Test Product)
- Registration Number
- NCT06954181
- Lead Sponsor
- HALEON
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Voltaren® Schmerzgel forte; 2.32% Applied Without Applicator (Method 1) 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) 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) 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.
- Primary Outcome Measures
Name Time Method Concentration of Voltaren® Schmerzgel forte; 2.32% (Diclofenac) in Water (Milligrams per Liter [mg/L]) 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%) either by hand or using an applicator and subsequent washing will be determined with High-performance liquid chromatography (HPLC).
Amount of Test Product Residues by Gravimetrical Measurements (Milligrams [mg]) Day 1, Day 3 and Day 5 Test product (Voltaren® Schmerzgel forte; 2.32%) residues will be collected using Method 3 (application of the test product using an applicator and subsequent wiping with a paper towel and washing). The paper towels will be weighed before and after application. The amount of test product residues (mg) in paper towel will be determined using gravimetrical measurements.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SGS proderm GmbH
🇩🇪Schenefeld, Germany