Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods

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.

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.