Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT03703895
Brief 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.
Detailed Description:
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. Subjects will complete 4 study visits according to the following 4-week timeline: Day \[-30\] - \[-1\] (Screening), Day 0 (Baseline), Day 14 (Follow-Up), Day 28 (Follow-up \| ET \| EOS). At Visit 2, IP will be dispensed and baseline readings of efficacy as well as safety/tolerability assessments will be obtained prior to application of the IP. Subjects will apply IP twice daily and compliance will be monitored by periodically reviewing the subject diary. The evaluations that will be used to measure efficacy of the product will be the Investigator's Global Assessment and Hand Eczema Severity Index. The Subject's Local Dermal Tolerability Assessment and Local Skin Reaction Assessment will be used throughout the course of the study to evaluate tolerability. Additionally, the actions that will be taken to evaluate safety will be the monitoring of adverse events, vital signs, and changes in concomitant medications. Digital photographs will be taken at each visit (excluding Visit 3).
Study:
NCT03703895
Study Brief:
Protocol Section:
NCT03703895