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

NeoStrata

Status: Completed

Conditions: Plaque Psoriasis

Treatments: Other: LCD Solution with NB-UVB Phototherapy; Device: NB-UVB Light Device (311-315 nm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708851

07-LCDUVB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 2 patient groups

NB-UVB Light Device (311-315 nm)

Active Comparator group

Description:

the subject will receive full body NB-UVB light therapy

Treatment:

Device: NB-UVB Light Device (311-315 nm)

LCD Solution with NB-UVB Phototherapy

Experimental group

Description:

on half of the body will receive LCD while the full body receives NB-UVB therapy

Treatment:

Device: NB-UVB Light Device (311-315 nm)

Other: LCD Solution with NB-UVB Phototherapy