Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05461456
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%
Sponsor:
OrchestratePharma GmbH
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATOFEX-1
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: