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

April 2, 2015 updated by: NeoStrata Company, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NB-UVB Light Device (311-315 nm)
the subject will receive full body NB-UVB light therapy
Device: NB-UVB Light Device (311-315 nm)
NB-UVB Phototherapy: 3 light exposures / week
Other Names:
  • Ultralite Model # V4848NB
Experimental: LCD Solution with NB-UVB Phototherapy
on half of the body will receive LCD while the full body receives NB-UVB therapy
Device: NB-UVB Light Device (311-315 nm)
NB-UVB Phototherapy: 3 light exposures / week
Other Names:
  • Ultralite Model # V4848NB
Other: LCD Solution with NB-UVB Phototherapy

LCD Solution: 2 applications / day

NB-UVB Phototherapy: 3 light sessions / week

Other Names:
  • LCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.
Time Frame: 12 weeks of treatment
Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.
12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoStrata Company, Inc.

Investigators

  • Principal Investigator: Jerry Bagel, MD, Windsor Dermatology, East Windsor, NJ 08520

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-LCDUVB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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