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Completed

NCT Number: NCT00708851

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

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.

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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Windsor Dermatology

East Windsor, New Jersey, 08520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCD Solution with NB-UVB Phototherapy

Other

LCD Solution: 2 applications / day

NB-UVB Phototherapy: 3 light sessions / week

Other names: LCD

NB-UVB Light Device (311-315 nm)

Device

NB-UVB Phototherapy: 3 light exposures / week

Other names: Ultralite Model # V4848NB

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.

    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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NeoStrata Company, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 2, 2008
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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