Clinical trial NCT03703895: A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Dermatitis
Lead sponsor: The Center for Clinical and Cosmetic Research
Sponsor class: OTHER
Collaborators: name: Afecta Pharmaceuticals
First posted: 2018-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome Measure for Efficacy (IGA)
timeFrame: Baseline; Day 14; Day 28
measure: Primary Outcome Measure for Efficacy (HECSI)
timeFrame: Baseline; Day 14; Day 28
Secondary outcomes:
measure: Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
timeFrame: Baseline; Day 14; Day 28
measure: Secondary Outcome Measures for Tolerability and Safety (LSR)
timeFrame: Baseline; Day 14; Day 28
measure: Measures for Safety (Adverse Events/Concomitant Medications)
timeFrame: Baseline; Day 14; Day 28
Other outcomes:
Locations:
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
Study officials:
affiliation: The Center for Clinical and Cosmetic Research
name: Mark S Nestor, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: