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

Plaque Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708851
• Other study ID #: 07-LCDUVB
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: April 2, 2015
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2015
• Source: NeoStrata Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Other:
• LCD Solution with NB-UVB Phototherapy
LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week

Device:
• NB-UVB Light Device (311-315 nm)
NB-UVB Phototherapy: 3 light exposures / week

Locations

Country	Name	City	State
United States	Windsor Dermatology	East Windsor	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NeoStrata Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.	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	Yes