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	Treatment or Intervention	Phase
Psoriasis	Device: UV-B Lightsource and Fiber Optic Comb	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114-2696,  United States

Study ID Numbers:  NIAMS-049; R44 AR44449
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  December 16, 2000
ClinicalTrials.gov Identifier:  NCT00007293
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08