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Scalp Psoriasis Treatment With a Fiber Optic Comb

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
UV-B Lightsource and Fiber Optic Comb
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Phototherapy, Psoriasis, Scalp psoriasis, Fiber optic, Light comb, UV source

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 16, 2000
Last Updated
January 2, 2007
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00007293
Brief Title
Scalp Psoriasis Treatment With a Fiber Optic Comb
Official Title
Phototherapy of Psoriasis of the Scalp With a UV-B Emitting Fiber Optic Comb
Study Type
Interventional

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Phototherapy, Psoriasis, Scalp psoriasis, Fiber optic, Light comb, UV source

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
UV-B Lightsource and Fiber Optic Comb

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15186234
Citation
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.
Results Reference
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Scalp Psoriasis Treatment With a Fiber Optic Comb

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