Scalp Psoriasis Treatment With a Fiber Optic Comb

Psoriasis Clinical Trial

Official title:

Phototherapy of Psoriasis of the Scalp With a UV-B Emitting Fiber Optic Comb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007293
• Other study ID #: R44AR044449
• Secondary ID: NIAMS-049
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2000
• Last updated: January 2, 2007
• Start date: August 2000
• Est. completion date: July 2002

Study information

• Verified date: February 2003
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• UV-B Lightsource and Fiber Optic Comb

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation