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

Primary Purpose

Hand Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topical AFX5931
Topical Placebo
Sponsored by
The Center for Clinical and Cosmetic Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Dermatitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator

Placebo Comparator

Arm Description

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.

Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.

Outcomes

Primary Outcome Measures

Primary Outcome Measure for Efficacy (IGA)
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 Almost clear: Just perceptible scaling and/or erythema; Mild disease: Mild scaling and/or mild erythema, and/or mild cracking Moderate disease: Moderate scaling and/or erythema, and/or moderate cracking/fissuring Severe disease: Severe scaling and/or severe erythema, and/or severe cracking/fissuring Dorsal and palmar surfaces of the hand are evaluated together.
Primary Outcome Measure for Efficacy (HECSI)
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.

Secondary Outcome Measures

Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
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 = Mild: Occasional, slight itching/scratching = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
Secondary Outcome Measures for Tolerability and Safety (LSR)
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 = Mild (Slight pinkness present) = Moderate (Definite, dull redness that is clearly distinguishable) = Severe (Intense, deep redness) Induration/Papulation: inflammation, swelling 0 = No elevation = Mild (Slightly perceptible elevation) = Moderate (Clearly perceptible elevation but not extensive) = Severe (Marked and extensive elevation) Lichenification: thickening upper layers of skin 0 = No thickening = Mild (Slight thickening of skin discernible only by touch and with skin markings minimally exaggerated) = Moderate (Definite thickening of the skin with skin markings exaggerated so that they form a visible crisscross pattern) = Severe (Thickened, indurated skin with skin markings visibly portraying an exaggerated crisscross pattern)
Measures for Safety (Adverse Events/Concomitant Medications)
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.

Full Information

First Posted
October 8, 2018
Last Updated
December 7, 2022
Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
Afecta Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03703895
Brief Title
A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis
Acronym
AFX5931
Official Title
"A Double-Blind, Pilot Study to Evaluate the Efficacy and Safety of Topical AFX 5931 in the Treatment of Mild to Moderate Hand Dermatitis"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
Afecta Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
Topical AFX5931
Intervention Description
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
Intervention Type
Drug
Intervention Name(s)
Topical Placebo
Intervention Description
Placebo Comparator, Topical Placebo.
Primary Outcome Measure Information:
Title
Primary Outcome Measure for Efficacy (IGA)
Description
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 Almost clear: Just perceptible scaling and/or erythema; Mild disease: Mild scaling and/or mild erythema, and/or mild cracking Moderate disease: Moderate scaling and/or erythema, and/or moderate cracking/fissuring Severe disease: Severe scaling and/or severe erythema, and/or severe cracking/fissuring Dorsal and palmar surfaces of the hand are evaluated together.
Time Frame
Baseline; Day 14; Day 28
Title
Primary Outcome Measure for Efficacy (HECSI)
Description
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.
Time Frame
Baseline; Day 14; Day 28
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Description
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 = Mild: Occasional, slight itching/scratching = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
Time Frame
Baseline; Day 14; Day 28
Title
Secondary Outcome Measures for Tolerability and Safety (LSR)
Description
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 = Mild (Slight pinkness present) = Moderate (Definite, dull redness that is clearly distinguishable) = Severe (Intense, deep redness) Induration/Papulation: inflammation, swelling 0 = No elevation = Mild (Slightly perceptible elevation) = Moderate (Clearly perceptible elevation but not extensive) = Severe (Marked and extensive elevation) Lichenification: thickening upper layers of skin 0 = No thickening = Mild (Slight thickening of skin discernible only by touch and with skin markings minimally exaggerated) = Moderate (Definite thickening of the skin with skin markings exaggerated so that they form a visible crisscross pattern) = Severe (Thickened, indurated skin with skin markings visibly portraying an exaggerated crisscross pattern)
Time Frame
Baseline; Day 14; Day 28
Title
Measures for Safety (Adverse Events/Concomitant Medications)
Description
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.
Time Frame
Baseline; Day 14; Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a male or non-pregnant female, 12 years of age and older. Subject is willing and able to provide written informed consent for the study. 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. Subject has clinical diagnosis of mild to moderate hand dermatitis for at least 3 months. Subject has a baseline Investigator's Global Assessment (IGA) score of 2 or 3 (disease severity of mild or moderate). 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. 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: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject is currently enrolled in an investigational drug or device study. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline. Subject has active cutaneous bacterial or viral infection in any treatment area (clinically infected hand dermatitis) at Visit 2/Baseline. 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 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 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 Subject has a history of sensitivity to any of the ingredients in the investigational product 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nestor, M.D, Ph.D.
Organizational Affiliation
The Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.afectapharm.com/
Description
Afecta Pharmaceuticals

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

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