Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05461456
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-07-02
Brief Title:
Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1
Sponsor:
OrchestratePharma GmbH
Organization:
OrchestratePharma GmbH
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:
None
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?:
None