Trial · NCT05461456

Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

NCT05461456, Phase 1, Completed, OrchestratePharma GmbH

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%. Trials, record NCT05461456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05461456

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%
NCT number: NCT05461456
Status: Completed
Phases: Phase 1
Enrollment: 12 participants, actual
Lead sponsor: OrchestratePharma GmbH
Conditions: Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Rash, Rash, Pruritus, Urticaria, Urticaria Chronic, Psoriasis, Psoriasis Vulgaris, Skin Rash, Skin Inflammation, Eczema
Interventions: Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
First posted: 2022-07-18
Last updated: 2023-03-29

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adverse Events	0-72 hours	Incidence and severity of local and systemic Adverse Events (AEs).
Primary	Cmax	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.	Peak plasma concentration (Cmax)
Primary	Tmax	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.	Peak plasma time (Tmax)
Primary	T½	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.	Half-life (T½)
Primary	AUC0-72h	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.	Area under the curve (AUC0-72h)
Secondary	Dermal tolerability and treatment perception	-60 minutes, 30 minutes, 72 hours	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.
Other	Radial pulse	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.	Radial pulse (beats per minute)
Other	Systolic blood pressure	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 (mmHg)
Other	Diastolic blood pressure	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 (mmHg)
Other	Respiratory rate	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.	Respiratory rate (breaths per minute)

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05461456

GET https://conductscience.org/api/trials/v1/NCT05461456/registered

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