Healthy Participants
Conditions
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.
Interventions
DRUGVoltaren® Schmerzgel forte; 2.32% (Test Product)
Voltaren® Schmerzgel forte; 2.32% containing 2.32% Diclofenac-N-Ethylethanamin.
Sponsors
HALEON
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Voltaren® Schmerzgel Forte; 2.32% (Diclofenac) in Water (Milligrams Per Liter [mg/L]) After Washing | 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) | 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. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted at a single center in Germany.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
Outcome results
None listed