Clinical trial NCT00708851: NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Psoriasis
Keywords: psoriasis
Lead sponsor: NeoStrata Company, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.
timeFrame: 12 weeks of treatment
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
Study officials:
affiliation: Windsor Dermatology, East Windsor, NJ 08520
name: Jerry Bagel, MD
role: PRINCIPAL_INVESTIGATOR
References: