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Atopic DermatitisPhase 1ATOFEX-1NCT05461456

Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

A Phase 1 study testing Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by OrchestratePharma GmbH at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBangladesh
Study dates
1 Apr 2022to 16 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Able to comply with the study procedures in the opinion of the PI/CI.
  • Able to give written consent for participation in the study.
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  • Subjects who have taken at least two doses of COVID 19 vaccine and possess certificate for the same.
  • Intact skin without major scarring or tattoos.
  • An unusual diet (e.g., low salt), for any medical reason or non-medical reason for three weeks prior to receiving the study drug and throughout the subjects' participation in the study. In any such case subject selection will be at the discretion of the PI/CI.

Who cannot join

  • 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.
  • Ingestion of any medicine at any time within 14 days before Check In. In any such case subject selection will be at the discretion of the PI/CI and medicine taken will be recorded.
  • Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticaria.
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  • History of substance abuse and or addiction to drugs and alcohol.
  • Smokers, who smoke 9 or more cigarettes / day or inability to abstain during the study.
  • Habituated to drinking tea or coffee (more than 5 cups/day) or inability to abstain during the study
  • Habituated to tobacco/tobacco containing products (more than 10 gm/day) or inability to abstain during the study.
  • A positive result for Serological tests [including hepatitis B \& C, HIV antibody and syphilis {VDRL (RPR) /TPHA}] tests.
  • Donation of blood (1 unit: 350 mL) within 90 days prior to receiving the first dose of study drug.
  • The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • BCT Ltd.

    Dhaka, Ramna, 1217

Other trials in Bangladesh

About this study

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

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.

Read the 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.

Being tested
Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
Keywords
Inflammatory Skin Disease, Pruritus, Rash, Atopic Dermatitis, Urticaria, Psoriasis, Eczema
Medical subject headings
Dermatitis, Atopic, Exanthema, Pruritus, Urticaria, Chronic Urticaria, Psoriasis, Dermatitis, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)Drug

    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.

Study groups in NCT05461456
Study groupRoleWhat they receive
OP2101ExperimentalTreatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
Receives: Drug: Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Incidence and severity of local and systemic Adverse Events (AEs).

    Measured: 0-72 hours

  2. Cmax

    Peak plasma concentration (Cmax)

    Measured: 0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

  3. Tmax

    Peak plasma time (Tmax)

    Measured: 0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

  4. T½

    Half-life (T½)

    Measured: 0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

  5. AUC0-72h

    Area under the curve (AUC0-72h)

    Measured: 0.00 (pre-dose) and at 1.00, 4.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00- & 72.00-hours post-dosing.

Secondary outcomes (1)

  1. Dermal tolerability and treatment perception

    Skin- and Lotion Assessment Questionnaire (SLAQ) is a proprietary 3-part questionnaire:

    • Part 1 is a 6-modalities, 4-grade self-assessment of skin perceptions.
    • Part 2 is the Local Tolerability Scale (LTS).
    • Part 3 is a 7-modalities, 5-grade assessment of cream properties.

    Measured: -60 minutes, 30 minutes, 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start1 Apr 2022
  3. Primary completion16 Oct 2022
  4. Study completion16 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461456
Sponsor's protocol ID
iVRS-CD-22-021
Acronym
ATOFEX-1
Status last verified
Mar 2023
First submitted
2 Jul 2022
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by OrchestratePharma GmbH at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 0-72 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05461456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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