PsoriasisPhase 1/2NCT00007293
Scalp Psoriasis Treatment With a Fiber Optic Comb
A Phase 1/2 study testing UV-B Lightsource and Fiber Optic Comb in people with Psoriasis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study will test the safety and effectiveness of a novel fiber optic device for treating scalp psoriasis with ultraviolet (UV-B) light. A effective treatment is not currently available for people with scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- UV-B Lightsource and Fiber Optic Comb
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jul 2002
- Phase
- Phase 1/2
- 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 of either sex and any race or ethnic background with chronic, stable, bilateral psoriasis of the scalp.
Who cannot join
- Subjects who are currently taking systemic medications for psoriasis (e.g., methotrexate, retinoids).
- Subjects who are currently using or have used topical medications other than emollients in the past 6 weeks on their scalp.
- Patients with pustular psoriasis, known photosensitivity disorders, lupus erythematosus, or unstable major illnesses preventing participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
About this study
Official title: Phototherapy of Psoriasis of the Scalp With a UV-B Emitting Fiber Optic Comb
This study will test the safety and effectiveness of a novel fiber optic device for treating scalp psoriasis with ultraviolet (UV-B) light. A effective treatment is not currently available for people with scalp psoriasis. Present methods for treating psoriasis with UV-B light cannot be used for the scalp because hair is usually blocking the light from reaching the affected skin. Our method overcomes this problem with the use of a comb that has optical fibers to deliver light directly to the skin. We will evaluate this device in a clinical setting and will use the results to tailor the design of the comb before producing it in large quantities.
Read the detailed description
Scalp psoriasis can be treated with a novel fiber optic delivery system that irradiates the psoriatic scalp of patients with UV-B light via an optical fiber comb. Current methods for treatment of psoriasis with light are not applicable to the scalp because hair is usually blocking the light from reaching the affected skin. Our method overcomes this problem with the use of a comb that has optical fibers to deliver light directly to the skin. We have developed a UV-B light source and a fiber optic comb for use in clinics and doctors' offices. We will evaluate this device in a clinical setting.
The results of this trial will provide data about the effectiveness of the device. We will use these results to tailor the design before it is ready for volume production. If successful, the UV-B light source and fiber optic comb will provide treatment to people affected with scalp psoriasis. At present, these people do not have any effective treatment available to them.
- Conditions
- Psoriasis
- Being tested
- UV-B Lightsource and Fiber Optic Comb
- Keywords
- Phototherapy, Psoriasis, Scalp psoriasis, Fiber optic, Light comb, UV source
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV-B Lightsource and Fiber Optic CombDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2000 (estimated)
- Study startAug 2000
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007293
- Sponsor's protocol ID
- R44AR044449
- Other IDs
- NIAMS-049
- Status last verified
- Feb 2003
- First submitted
- 16 Dec 2000
- Last updated
- 4 Jan 2007
- Results posted
- No
Publications
Taneja A, Racette A, Gourgouliatos Z, Taylor CR. Broad-band UVB fiber-optic comb for the treatment of scalp psoriasis: a pilot study. Int J Dermatol. 2004 Jun;43(6):462-7. doi: 10.1111/j.1365-4632.2004.01993.x.
PubMed 15186234
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy of Psoriasis of the Scalp With a UV-B Emitting Fiber Optic Comb
- ClinicalTrials.gov ID
- NCT00007293
- Acronym / sponsor ID
- R44AR044449
- Conditions
- Psoriasis
- Keywords
- Phototherapy, Psoriasis, Scalp psoriasis, Fiber optic, Light comb, UV source
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Jul 2002
- First posted
- 18 Dec 2000 (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 will test the safety and effectiveness of a novel fiber optic device for treating scalp psoriasis with ultraviolet (UV-B) light. A effective treatment is not currently available for people with scalp psoriasis. Present methods for treating psoriasis with UV-B light cannot be used for the scalp because hair is usually blocking the light from reaching the affected skin. Our method overcomes this problem with the use of a comb that has optical fibers to deliver light directly to the skin. We will evaluate this device in a clinical setting and will use the results to tailor the design of the comb before producing it in large quantities.
Detailed description
Scalp psoriasis can be treated with a novel fiber optic delivery system that irradiates the psoriatic scalp of patients with UV-B light via an optical fiber comb. Current methods for treatment of psoriasis with light are not applicable to the scalp because hair is usually blocking the light from reaching the affected skin. Our method overcomes this problem with the use of a comb that has optical fibers to deliver light directly to the skin. We have developed a UV-B light source and a fiber optic comb for use in clinics and doctors' offices. We will evaluate this device in a clinical setting.
The results of this trial will provide data about the effectiveness of the device. We will use these results to tailor the design before it is ready for volume production. If successful, the UV-B light source and fiber optic comb will provide treatment to people affected with scalp psoriasis. At present, these people do not have any effective treatment available to them.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects of either sex and any race or ethnic background with chronic, stable, bilateral psoriasis of the scalp.
Key exclusion criteria (3 listed)
- Subjects who are currently taking systemic medications for psoriasis (e.g., methotrexate, retinoids).
- Subjects who are currently using or have used topical medications other than emollients in the past 6 weeks on their scalp.
- Patients with pustular psoriasis, known photosensitivity disorders, lupus erythematosus, or unstable major illnesses preventing participation in the study.
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 |
|---|---|---|
| UV-B Lightsource and Fiber Optic Comb | Device | – |
Primary outcome
Not reported in the source record.
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 4 Jan 2007.
- Background: PubMed 15186234Taneja A, Racette A, Gourgouliatos Z, Taylor CR. Broad-band UVB fiber-optic comb for the treatment of scalp psoriasis: a pilot study. Int J Dermatol. 2004 Jun;43(6):462-7. doi: 10.1111/j.1365-4632.2004.01993.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UV-B Lightsource and Fiber Optic Comb in people with Psoriasis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 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 3 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 2007. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007293, which also lists 1 linked publication.
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 2007.