NCT00007293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

January 4, 2007

Status Verified

February 1, 2003

First QC Date

December 16, 2000

Last Update Submit

January 2, 2007

Conditions

Psoriasis

Keywords

PhototherapyPsoriasisScalp psoriasisFiber opticLight combUV source

Interventions

UV-B Lightsource and Fiber Optic CombDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of either sex and any race or ethnic background with chronic, stable, bilateral psoriasis of the scalp.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Related 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. doi: 10.1111/j.1365-4632.2004.01993.x.

    PMID: 15186234BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 16, 2000

First Posted

December 18, 2000

Study Start

August 1, 2000

Study Completion

July 1, 2002

Last Updated

January 4, 2007

Record last verified: 2003-02

Locations

US(1)