NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study - Full Text View

Sponsored by:	NeoStrata Company, Inc.
Information provided by:	NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:	NCT00708851

Purpose

The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.

Condition	Intervention
Chronic Plaque Psoriasis	Other: LCD Solution with NB-UVB Phototherapy Device: NB-UVB Light Device (311-315 nm)

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Safety/Efficacy Study
Official Title:	A Clinical Evaluation of Safety & Efficacy of Adding an at-Home Topical LCD Solution Regimen to Standard Narrowband UVB Phototherapy Administered 3 Times Weekly to Adults With Generalized Plaque Psoriasis.

Further study details as provided by NeoStrata Company, Inc.:

Primary Outcome Measures:

The difference in bilateral static Physician's Global Assessment (sPGA) scores, and Erythema, Scaling, and Induration (ESI) scores of bilateral target lesion scores across visits for each condition and between conditions. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The difference in number and severity of treatment-related adverse reactions between conditions. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	April 2007
Study Completion Date:	March 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator NB-UVB Alone	Device: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week
1: Experimental LCD+NB-UVB	Other: LCD Solution with NB-UVB Phototherapy LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years old or older
able and willing to provide written informed consent
symmetrical plaque psoriasis
able and willing to attend phototherapy sessions and apply LCD at home
negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

current or recent other treatments for psoriasis
hypersensitivity to LCD or UVB light
current or previous skin cancer
pregnant or nursing mother
participating in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708851

Locations

United States, New Jersey
Windsor Dermatology
East Windsor, New Jersey, United States, 08520

Sponsors and Collaborators

NeoStrata Company, Inc.

Investigators

Principal Investigator:

Jerry Bagel, MD

Windsor Dermatology, East Windsor, NJ 08520

More Information

Responsible Party:	NeoStrata Company, Inc. ( Irina Brouda )
Study ID Numbers:	07-LCDUVB
Study First Received:	June 27, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00708851
Health Authority:	United States: Institutional Review Board

Keywords provided by NeoStrata Company, Inc.:

psoriasis

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 14, 2009