NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study
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.
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2007
1 active site
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
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedResults Posted
Study results publicly available
April 20, 2015
CompletedApril 20, 2015
April 1, 2015
9 months
June 27, 2008
November 13, 2014
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).
12 weeks of treatment
Secondary Outcomes (1)
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.
12 weeks of treatment
Study Arms (2)
NB-UVB Light Device (311-315 nm)
ACTIVE COMPARATORthe subject will receive full body NB-UVB light therapy
LCD Solution with NB-UVB Phototherapy
EXPERIMENTALon half of the body will receive LCD while the full body receives NB-UVB therapy
Interventions
LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week
NB-UVB Phototherapy: 3 light exposures / week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Windsor Dermatology
East Windsor, New Jersey, 08520, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is a bilateral pilot study including 12 subjects. Subjects will apply the liquor carbonis distillate (LCD) solution to one half of their body, while receiving narrow-band ultraviolet B (NB-UVB) light therapy across their whole body.
Results Point of Contact
- Title
- Jerry Bagel, MD
- Organization
- Psoriasis Treatment Center of Central New Jersey
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Bagel, MD
Windsor Dermatology, East Windsor, NJ 08520
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
April 1, 2007
Primary Completion
January 1, 2008
Study Completion
March 1, 2008
Last Updated
April 20, 2015
Results First Posted
April 20, 2015
Record last verified: 2015-04