Contact DermatitisPhase 1NCT00614289
Novel Topical Treatment of Hand Dermatitis (Eczema)
A Phase 1 study testing Epikeia Coatings in people with Contact Dermatitis and Eczema, Contact, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Dermatitis, Eczema, Contact
- What is being tested?
- Epikeia Coatings
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following inclusion criteria:
- 18 years of age or older;
- have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
- be generally healthy, as determined by brief medical history;
- have a negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms \& spermacide, implants, injectables, combined oral contraceptives, intrauterine device (IUD's), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, [i.e., birth control pill (BCP)], the dose and type of BCP should stay constant 1 month prior to enrollment and throughout the study, and
- be capable of understanding and signing the consent form.
Who cannot join
- Subjects will be excluded from the study if they:
- have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
- have severe and very severe hand dermatitis according to the Investigator Global Assessment;
- have severe vesiculation or bullae;
- have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
- have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
Show all 10Show fewer
- have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study
- have a history of alcoholism or drug abuse;
- have a history or current evidence of a chronic or infectious skin disease; and
- are pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria; Pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHSC Houston, Dermatology Clincial Research Center
Houston, Texas, 77030
About this study
Official title: Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
Read the detailed description
Hand dermatitis was chosen for investigation due to high incidence and typical symmetrical involvement that allows for right/left treatment comparisons. Hand dermatitis is also important due to its implication on healthcare workers in particular, where frequent hand washing and chronic occlusion from gloving, provide a route for skin sensitization to natural rubber latex proteins increase the risk of colonization of microorganisms on the skin, and thereby increase the likelihood of contact dermatitis.
This feasibility study will be performed to evaluate the efficacy of PVDF coatings in treating chronic hand dermatitis.
- Conditions
- Contact Dermatitis, Eczema, Contact
- Being tested
- Epikeia Coatings
- Keywords
- Mild to Moderate Hand Dermatitis, Hand Eczema
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epikeia CoatingsDevice
Topical skin coating
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores.
Measured: 85 Days
Secondary outcomes (1)
Ordinal scales measuring subjective efficacy, pain and itching.
Measured: 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Adelaide A. Hebert, MD, Principal investigator, University of Texas Health Science Center, Department of Dermatoloy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614289
- Sponsor's protocol ID
- HSC-MS-06-0347
- Other IDs
- NIH Grant 1R43AR525441-1A1
- Status last verified
- Oct 2008
- First submitted
- 31 Jan 2008
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial
- ClinicalTrials.gov ID
- NCT00614289
- Acronym / sponsor ID
- HSC-MS-06-0347
- Conditions
- Contact Dermatitis, Eczema, Contact
- Keywords
- Mild to Moderate Hand Dermatitis, Hand Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
Detailed description
Hand dermatitis was chosen for investigation due to high incidence and typical symmetrical involvement that allows for right/left treatment comparisons. Hand dermatitis is also important due to its implication on healthcare workers in particular, where frequent hand washing and chronic occlusion from gloving, provide a route for skin sensitization to natural rubber latex proteins increase the risk of colonization of microorganisms on the skin, and thereby increase the likelihood of contact dermatitis.
This feasibility study will be performed to evaluate the efficacy of PVDF coatings in treating chronic hand dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older;
- have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
- be generally healthy, as determined by brief medical history;
- have a negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms \& spermacide, implants, injectables, combined oral contraceptives, intrauterine device (IUD's), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, [i.e., birth control pill (BCP)], the dose and type of BCP should stay constant 1 month prior to enrollment and throughout the study, and
- be capable of understanding and signing the consent form.
Key exclusion criteria (10 listed)
- have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
- have severe and very severe hand dermatitis according to the Investigator Global Assessment;
- have severe vesiculation or bullae;
- have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
- have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
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 |
|---|---|---|
| Epikeia CoatingsTopical skin coating | Device | – |
Primary outcome
The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores.
Time frame: 85 Days
1 secondary outcome
Ordinal scales measuring subjective efficacy, pain and itching.
Time frame: 85 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
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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.
Adelaide A. Hebert, MD principal investigator
University of Texas Health Science Center, Department of Dermatoloy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epikeia Coatings in people with Contact Dermatitis and Eczema, Contact, run by Biomedical Development Corporation 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 6 inclusion and 10 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 8 Mar 2010. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores. (time frame: 85 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2010.