DermatitisEarly Phase 1NCT00217009
Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.
A Early Phase 1 study testing Narrowband Ultraviolet B (TL-01UVB) Therapy and Topical Psoralen plus ultraviolet A (PUVA) in people with Dermatitis and Psoriasis, run by Mayo Clinic at 1 site in United States.
Trial summary
Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Psoriasis
- What is being tested?
- Narrowband Ultraviolet B (TL-01UVB) Therapy and Topical Psoralen plus ultraviolet A (PUVA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2008
- Phase
- Early 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
- Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.
Who cannot join
- Age <18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.
- Conditions
- Dermatitis, Psoriasis
- Being tested
- Narrowband Ultraviolet B (TL-01UVB) Therapy, Topical Psoralen plus ultraviolet A (PUVA)
- Medical subject headings
- Dermatitis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband Ultraviolet B (TL-01UVB) TherapyProcedure or surgery
Topical Psoralen plus ultraviolet A (PUVA)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Narrowband Ultraviolet B (TL-01UVB) Therapy | Active comparator | treatments - 3x weekly for 15 months Receives: Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapy |
| Topical Psoralen plus ultraviolet A (PUVA) | Active comparator | Treatments - 3x weekly for 15 months Receives: Procedure: Topical Psoralen plus ultraviolet A (PUVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatments required to reach clearance
Measured: Baseline to 15 months
Secondary outcomes (5)
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Measured: Baseline to 15 months
Change in global score
Measured: Baseline to 15 months
Number of patients reaching clearance
Measured: Baseline to 15 months
Adverse effects
Measured: Baseline to 15 months
Number of days in remission
Measured: Baseline to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Mark D. Davis, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217009
- Sponsor's protocol ID
- 2435-04
- Status last verified
- May 2015
- First submitted
- 14 Sep 2005
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
- ClinicalTrials.gov ID
- NCT00217009
- Acronym / sponsor ID
- 2435-04
- Conditions
- Dermatitis, Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Sep 2005 (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.
Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrowband Ultraviolet B (TL-01UVB) Therapy | Active comparator | Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapytreatments - 3x weekly for 15 months |
| Topical Psoralen plus ultraviolet A (PUVA) | Active comparator | Procedure: Topical Psoralen plus ultraviolet A (PUVA)Treatments - 3x weekly for 15 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.
Key exclusion criteria (1 listed)
- Age <18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
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 |
|---|---|---|
| Narrowband Ultraviolet B (TL-01UVB) Therapy | Procedure or surgery | Narrowband Ultraviolet B (TL-01UVB) Therapy |
| Topical Psoralen plus ultraviolet A (PUVA) | Procedure or surgery | Topical Psoralen plus ultraviolet A (PUVA) |
Primary outcome
Number of treatments required to reach clearance
Time frame: Baseline to 15 months
5 secondary outcomes
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Time frame: Baseline to 15 months
Change in global score
Time frame: Baseline to 15 months
Number of patients reaching clearance
Time frame: Baseline to 15 months
Adverse effects
Time frame: Baseline to 15 months
Number of days in remission
Time frame: Baseline to 15 months
Results and safety
The study was stopped early (reason given: Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Mark D. Davis, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Narrowband Ultraviolet B (TL-01UVB) Therapy and Topical Psoralen plus ultraviolet A (PUVA) in people with Dermatitis and Psoriasis, run by Mayo Clinic 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 May 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.). Results are not available in the source record.
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?
Number of treatments required to reach clearance (time frame: Baseline to 15 months). 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 20 May 2015.