CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Topical AFX5931 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703895
NCT03703895Phase 4Completed
CompareCT.gov

"A Double-Blind, Pilot Study to Evaluate the Efficacy and Safety of Topical AFX 5931 in the Treatment of Mild to Moderate Hand Dermatitis"

The Center for Clinical and Cosmetic Research·interventional·Posted Oct 12, 2018·Updated Jan 4, 2023

In Brief

A Phase 4 clinical trial evaluating Topical AFX5931 and Topical Placebo for Hand Dermatitis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is a double-blind, pilot study with 20 subjects to determine the tolerability and efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis. Subjects are screened up to 30 days before the baseline visit. Subjects who meet the eligibility criteria may qualify for the study. Subjects will be randomized in a 3:1 ratio to receive either the active or vehicle medication. 15 subjects will receive the active, therapeutic product and 5 subjects will receive the inactive, vehicle product.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHand Dermatitis
CountriesUnited States
CollaboratorsAfecta Pharmaceuticals

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 12, 2018
Enrollment StartSep 18, 2018
Primary CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.7 years ago

Interventions

Topical AFX5931drug

Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.

Topical Placebodrug

Placebo Comparator, Topical Placebo.