Completed

ATOFEX-1An Open Label, Single-Dose, Single-Treatment, Single-Period Safety and Bioavailability Study of Fexofenadine Hydrochloride Topical Lotion 1% in Healthy, Adult, Male Human Subjects

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What is being tested

Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Drug
Who is being recruted

Chronic Urticaria+22

+ Chronic Disease

+ Dermatitis

From 18 to 45 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorOrchestratePharma GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleAn Open Label, Single-Dose, Single-Treatment, Single-Period Safety and Bioavailability Study of Fexofenadine Hydrochloride Topical Lotion 1% in Healthy, Adult, Male Human Subjects
NCT05461456
Principal SponsorOrchestratePharma GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic UrticariaChronic DiseaseDermatitisDermatitis, AtopicEczemaExanthemaHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPruritusPsoriasisSigns and SymptomsSkin DiseasesSkin Diseases, GeneticSkin ManifestationsPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, PapulosquamousSkin Diseases, VascularDisease AttributesGenetic Diseases, Inborn

Criteria

9 inclusion criteria required to participate
Healthy male human subjects between 18 to 45 years of age (both inclusive).
Having a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 (both inclusive).
Have no abnormal findings during screening done 21 days prior to administration of study drug, medical history and examination, laboratory evaluations, 12-lead ECG recordings.
Has an optimum physical condition which enables subjects to be fit for a Pharmacokinetic sampling according to principal investigator's evaluation.
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13 exclusion criteria prevent from participating
Known hypersensitivity or idiosyncratic reaction to Fexofenadine Hydrochloride or any of the excipients in the formulation.
Diagnosed with, or a family history of, long QT syndrome (LQTS).
Skin disorders or current skin discomforts.
Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

BCT Ltd.

Dhaka, BangladeshOpen BCT Ltd. in Google Maps
CompletedOne Study Center