Hand DermatitisPhase 4AFX5931NCT03703895

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

A Phase 4 study testing Topical AFX5931 in people with Hand Dermatitis, run by The Center for Clinical and Cosmetic Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Hand Dermatitis
What is being tested?: Topical AFX5931
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2018to 4 Apr 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180

Other trials in United States

About this study

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"

Read the 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).

Conditions: Hand Dermatitis
Being tested: Topical AFX5931, Topical Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical AFX5931Drug
Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
Topical PlaceboDrug
Placebo Comparator, Topical Placebo.

Study groups in NCT03703895
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Topical Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline; Day 14; Day 28

Secondary outcomes (3)

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
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
Measured: Baseline; Day 14; Day 28
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
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)
Measured: Baseline; Day 14; Day 28
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.
Measured: Baseline; Day 14; Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 20184 Apr 2019

First posted12 Oct 2018
Study start18 Sep 2018
Primary completion4 Apr 2019
Study completion4 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hand DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03703895
Sponsor's protocol ID: CCCR 08-2018
Other IDs: AFX5931-A 07312018
Acronym: AFX5931
Status last verified: Dec 2022
First submitted: 8 Oct 2018
Last updated: 4 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis

All Hand Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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"
ClinicalTrials.gov ID: NCT03703895
Acronym / sponsor ID: AFX5931 / CCCR 08-2018
Conditions: Hand Dermatitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
Collaborators: Afecta Pharmaceuticals
Study start: 18 Sep 2018 (actual)
Primary completion: 4 Apr 2019 (actual)
Study completion: 4 Apr 2019 (actual)
First posted: 12 Oct 2018 (actual)
Results: Posted 23 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Comparator	Active comparator	Drug: Topical AFX5931Active 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	Placebo comparator	Drug: Topical PlaceboPlacebo Comparator, Topical Placebo. Subjects will complete up to 4 study visits where Topical Placebo will be applied twice daily for 28 days.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (21 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical AFX5931Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.	Drug	Active Comparator
Topical PlaceboPlacebo Comparator, Topical Placebo.	Drug	Placebo Comparator

Primary outcome

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.
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.

3 secondary outcomes

Secondary Outcome Measures for Tolerability and Safety (Tolerability Assessment - Pruritus Score)
Time frame: Baseline; Day 14; Day 28
Secondary Outcome Measures for Tolerability and Safety (LSR)
Time frame: Baseline; Day 14; Day 28
Measures for Safety (Adverse Events/Concomitant Medications)
Time frame: Baseline; Day 14; Day 28

Results and safety

Results posted to the registry on 23 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Topical AFX5931 (Active Comparator)	15	15
Placebo Comparator	5	5

Primary outcome: Primary Outcome Measure for Efficacy (IGA)

Time frame: Baseline; Day 14; Day 28. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Active Comparator n = 15	Placebo Comparator n = 5
Baseline	2.33 (2.09 to 2.57)	2.20 (1.85 to 2.55)
Day 14	2.43 (2.18 to 2.68)	2 (2 to 2)
Day 28	2.20 (1.87 to 2.53)	2.25 (1.87 to 2.63)

Primary outcome: Primary Outcome Measure for Efficacy (HECSI)

Time frame: Baseline; Day 14; Day 28. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Active Comparator n = 15	Placebo Comparator n = 5
Baseline	22.67 (19.92 to 25.41)	25.6 (22.74 to 28.46)
Day 14	20.8 (17.17 to 24.43)	20 (17.23 to 22.77)
Day 28	20.6 (16.33 to 24.87)	21 (15.54 to 26.46)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Placebo Comparator	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Afecta PharmaceuticalsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hand Dermatitis

RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
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Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
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RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark S Nestor, M.D, Ph.D. principal investigator

The Center for Clinical and Cosmetic Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topical AFX5931 in people with Hand Dermatitis, run by The Center for Clinical and Cosmetic Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure for Efficacy (IGA) (time frame: Baseline; Day 14; Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.