A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis (AFX5931)

December 7, 2022 updated by: Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical and Cosmetic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is a male or non-pregnant female, 12 years of age and older.
  2. Subject is willing and able to provide written informed consent for the study.
  3. Subject is willing and able to apply the investigational product as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
  4. Subject has clinical diagnosis of mild to moderate hand dermatitis for at least 3 months.
  5. Subject has a baseline Investigator's Global Assessment (IGA) score of 2 or 3 (disease severity of mild or moderate).
  6. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of hand dermatitis or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
  7. Women of childbearing potential (WOCBP) must use an effective method of birth control or must be post-menopausal or surgically sterile. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Baseline.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject is currently enrolled in an investigational drug or device study.
  3. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline.
  4. Subject has active cutaneous bacterial or viral infection in any treatment area (clinically infected hand dermatitis) at Visit 2/Baseline.

  5. Subject has used any of the following therapies within 30 days prior to Visit 2/Baseline:

    • Systemic corticosteroids (oral and injectable [intravenous and intramuscular]) (Intranasal and Inhalational steroids are allowed if use is kept constant during the study)
    • UVA/UVB therapy
    • PUVA (psoralen plus ultraviolet A) therapy
    • Immunomodulators or immunosuppressive therapies
    • Interferon
    • Cytotoxic drugs (e.g., methotrexate, cyclophosphamide, azathioprine)
    • Oral retinoids

  6. Subject has used any of the following therapies within 14 days prior to Visit 2/Baseline:

    • Systemic antibiotics
    • Topical calcipotriene or other topical vitamin D preparations

  7. Subject has used any of the following therapies within 7 days prior to Visit 2/Baseline: • Topical and oral antihistamines

    • Topical antibiotics
    • Topical corticosteroids
    • Topical antifungals
  8. Subject has a history of sensitivity to any of the ingredients in the investigational product
  9. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active Comparator
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule. Subjects will complete up to 4 study visits where Topical AFX5931 will be applied twice daily for 28 days.
Drug: Topical AFX5931
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
Placebo Comparator: Placebo Comparator
Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.
Drug: Topical Placebo
Placebo Comparator, Topical Placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure for Efficacy (IGA)
Time Frame: Baseline; Day 14; Day 28

To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older assessed via the Investigator's Global Assessment

The investigator will rate the subject's hand dermatitis on a visual 5-point scale as follows:

0: Clear: No signs of HE

  1. Almost clear: Just perceptible scaling and/or erythema;
  2. Mild disease: Mild scaling and/or mild erythema, and/or mild cracking
  3. Moderate disease: Moderate scaling and/or erythema, and/or moderate cracking/fissuring
  4. Severe disease: Severe scaling and/or severe erythema, and/or severe cracking/fissuring

Dorsal and palmar surfaces of the hand are evaluated together.
Baseline; Day 14; Day 28
Primary Outcome Measure for Efficacy (HECSI)
Time Frame: Baseline; Day 14; Day 28

To measure the efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis in subjects 12 years of age or older, assessed via the Hand Eczema Severity Index (HECSI).

  • Investigator-rated clinical evaluation
  • Locations: fingertips, fingers (excluding tips), palms of hands, backs of hands, wrists
  • Intensity: graded on a visual 4-point scale (0 = no skin changes, 1 = mild disease, 2 = moderate, 3 = severe) for each Clinical sign (erythema, infiltration/papulation, vesicles, figures, scaling, and edema) at each location.
  • Extent: graded on a visual 5-point scale (0 = 0% ; 1 = 1-25% ; 2 = 26-50% ; 3 = 51-75% ; 4 = 76-100%) for each location.
  • Total HECSI score (0 to a maximum severity score of 360): the sum of the Intensity of clinical signs multiplied by the Extent grade for each location. The sum of the location scores is the Total HECSI score.
Baseline; Day 14; Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Time Frame: Baseline; Day 14; Day 28

The subjects will be asked to grade their feeling of itching at the application site using a 4-point tolerability scale, where 0=None, 1= Mild, 2= Moderate, and 3=Severe.

Pruritus: Definition: itching 0 = None: No itching

  1. = Mild: Occasional, slight itching/scratching
  2. = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep
  3. = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
Baseline; Day 14; Day 28
Secondary Outcome Measures for Tolerability and Safety (LSR)
Time Frame: Baseline; Day 14; Day 28

The investigator/ designee will describe their Local Skin Reaction (LSR) assessment of the subject's hands using a 4-point tolerability scale.

Erythema: abnormal redness of the skin 0 = No erythema

  1. = Mild (Slight pinkness present)
  2. = Moderate (Definite, dull redness that is clearly distinguishable)
  3. = Severe (Intense, deep redness)

Induration/Papulation: inflammation, swelling 0 = No elevation

  1. = Mild (Slightly perceptible elevation)
  2. = Moderate (Clearly perceptible elevation but not extensive)
  3. = Severe (Marked and extensive elevation)

Lichenification: thickening upper layers of skin 0 = No thickening

  1. = Mild (Slight thickening of skin discernible only by touch and with skin markings minimally exaggerated)
  2. = Moderate (Definite thickening of the skin with skin markings exaggerated so that they form a visible crisscross pattern)
  3. = Severe (Thickened, indurated skin with skin markings visibly portraying an exaggerated crisscross pattern)
Baseline; Day 14; Day 28
Measures for Safety (Adverse Events/Concomitant Medications)
Time Frame: Baseline; Day 14; Day 28

Monitoring the record of AEs (Adverse Events) and changes in concomitant medication/ procedures throughout the course of the study will be the primary mode of safety evaluation.

At each level of summarization (global, body system, and preferred term), a subject will be counted once if they reported one or more AEs at that level.

No statistical testing will be performed.
Baseline; Day 14; Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Center for Clinical and Cosmetic Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Afecta Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark S Nestor, M.D, Ph.D., The Center for Clinical and Cosmetic Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCCR 08-2018
  • AFX5931-A 07312018 (Other Identifier: Afecta Pharmaceuticals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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