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A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis

NCT03703895 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-04

Study results available
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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.

Conditions

  • Hand Dermatitis

Interventions

DRUG

Topical AFX5931

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

DRUG

Topical Placebo

Placebo Comparator, Topical Placebo.

Sponsors & Collaborators

  • Afecta Pharmaceuticals

    collaborator INDUSTRY

  • The Center for Clinical and Cosmetic Research

    lead OTHER

Principal Investigators

  • Mark S Nestor, M.D, Ph.D. · The Center for Clinical and Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-04-04
Completion
2019-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703895 on ClinicalTrials.gov