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

NCT03703895 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CCCR 08-2018AFX5931-A 07312018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 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)

  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 Outcomes (3)

• Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)

  Baseline; Day 14; Day 28

• Secondary Outcome Measures for Tolerability and Safety (LSR)

  Baseline; Day 14; Day 28

• Measures for Safety (Adverse Events/Concomitant Medications)

  Baseline; Day 14; Day 28

Study Arms (2)

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

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

Interventions

Topical AFX5931 DRUG

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

Active Comparator

Topical Placebo DRUG

Placebo Comparator, Topical Placebo.

Placebo Comparator

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Afecta Pharmaceuticals: collaborator

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Links

• Afecta Pharmaceuticals

Results Point of Contact

• Title: Dr. Mark Nestor
• Organization: Center for Clinical and Cosmetic Research

nestormd@admcorp.com

3059336716

Study Officials

• Mark S Nestor, M.D, Ph.D.

  The Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: September 18, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: January 4, 2023
• Results First Posted: November 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)