Scalp Psoriasis Treatment With a Fiber Optic Comb
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Device: UV-B Lightsource and Fiber Optic Comb |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Phototherapy of Psoriasis of the Scalp With a UV-B Emitting Fiber Optic Comb |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2000 |
| Estimated Study Completion Date: | July 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects of either sex and any race or ethnic background with chronic, stable, bilateral psoriasis of the scalp.
Exclusion Criteria:
- 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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00007293 History of Changes |
| Other Study ID Numbers: | R44 AR44449, NIAMS-049 |
| Study First Received: | December 16, 2000 |
| Last Updated: | January 2, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Phototherapy Psoriasis Scalp psoriasis |
Fiber optic Light comb UV source |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013