Clinical trial NCT06954181: Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
Official title: Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Voltaren® Schmerzgel forte; 2.32% (Diclofenac) in Water (Milligrams per Liter [mg/L])
timeFrame: Day 1, Day 3 and Day 5
measure: Amount of Test Product Residues by Gravimetrical Measurements (Milligrams [mg])
timeFrame: Day 1, Day 3 and Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
Study officials:
References: