A Phase 1 interventional study of Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) in Atopic Dermatitis, Atopic Dermatitis Eczema and Atopic Rash, sponsored by OrchestratePharma GmbH. Completed at 1 site in Bangladesh. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by OrchestratePharma GmbH · Phase 1, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 12 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with OrchestratePharma GmbH as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
Drug: Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
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.
Adverse Events
Incidence and severity of local and systemic Adverse Events (AEs).
Time frame: 0-72 hours
Cmax
Peak plasma concentration (Cmax)
Time frame: 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.
Tmax
Peak plasma time (Tmax)
Time frame: 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.
T½
Half-life (T½)
Time frame: 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.
AUC0-72h
Area under the curve (AUC0-72h)
Time frame: 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.
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.
Time frame: -60 minutes, 30 minutes, 72 hours
Radial pulse
Radial pulse (beats per minute)
Time frame: At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.
Systolic blood pressure
Systolic blood pressure (mmHg)
Time frame: At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Time frame: At the time of check-in, prior to dosing and at 03.00, 06.00, 12.00, 24.00, 36.00, 48.00, & 60.00 hours (± 60 minutes) post dose and prior to check-out.
Respiratory rate
Respiratory rate (breaths per minute)
Time frame: 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.
Body temperature
Body temperature (Celsius degrees)
Time frame: 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.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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