Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%
Condition: Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Rash; Rash; Pruritus; Urticaria; Urticaria Chronic; Psoriasis; Psoriasis Vulgaris; Skin Rash; Skin Inflammation; Eczema
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema; Pruritus; Urticaria; Exanthema; Chronic Urticaria; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigational lotion is envisaged as an short- and long term "Ease & Prevent"
      monotherapy for adults and children with mild to moderate eczema. With itch representing the
      most burdensome symptom in eczema, the main objectives with the lotion is fast and efficient
      itch relief, high tolerability, and high short- and long term safety. This phase 1 study aims
      to monitor skin tolerability, and how much of the active compound that is absorbed to the
      bloodstream.
    

Detailed description: 
      Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) is a novel formulation developed for
      the treatment of skin disorders characterized by pruritus. Research show that oral
      Fexofenadine Hydrochloride (FX) may lead to a small improvement of pruritus in patients with
      Atopic Dermatitis (AD). In clinical practice, oral antihistamines are widely used off-label
      for pruritus relief in AD, indicating a discrepancy in trial outcomes and real-life
      experience. The pre-study thesis postulates that the antipruritic effect of FX can be
      leveraged in a dose-response relationship facilitated by high topical concentration of FX in
      direct contact with the pathological process of the skin. The sponsor also suggest that the
      Cytosolic phospholipase A2 (cPLA2) blocking property of FX is an untapped resource that is
      likely to be dose-response dependent and manifested by means of high topical concentration in
      proximity to the inflammatory process. The repositioning of FX to a topical treatment has the
      potential for high safety, efficacy, fast relief, and ease of use. OP2101 is also aimed at
      inflammation control, suppression of bacterial imbalance, moisture retention, upregulation of
      antimicrobial peptides, and skin barrier restoration. As such, it targets six of the
      pathological pillars of AD. Assessment of topical tolerability and skin adsorption (systemic
      exposure) are the main objectives in this phase 1 study.
    

Intervention name(s): Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
Intervention type(s): Drug
Intervention description(s): Intervention:
The amount of study lotion (OP2101) used is 11 grams per subject, equivalent to 22 fingertip units (FTU). The lotion is applied to the subject on back and front of the trunk, both hands (palm and back) and both arms. An SOP for handling and application of the lotion ensures the 11 grams covers 54% of the body surface area (BSA) evenly without residue.
Comment:
The treatment is single-dose and single-treatment. The FTU is used to standardize the amount of cream being applied in clinical research. It is also used in clinical practice and hence connects the objectiveness of the trial to the clinical situation.
Intervention MeSH terms: Fexofenadine
Intervention model: Single Group Assignment
Intervention model description: The study is an 'Open Label, Single-Dose, Single-Treatment, Single-Period Safety and Bioavailability Study in Healthy, Adult, Male Human Subjects, where the subjects will be housed in the clinical facility from not less than 11 hours pre-dose till at least 72 hours post-dose. Altogether, the subject will stay for consecutive 03 days and 04 nights in the facility.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory Skin Disease; Pruritus; Rash; Atopic Dermatitis; Urticaria; Psoriasis; Eczema