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

Not Applicable
Completed
Conditions
Plaque Psoriasis
Interventions
Other: LCD Solution with NB-UVB Phototherapy
Device: NB-UVB Light Device (311-315 nm)
Registration Number
NCT00708851
Lead Sponsor
NeoStrata Company, Inc.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
LCD Solution with NB-UVB PhototherapyLCD Solution with NB-UVB Phototherapyon half of the body will receive LCD while the full body receives NB-UVB therapy
NB-UVB Light Device (311-315 nm)NB-UVB Light Device (311-315 nm)the subject will receive full body NB-UVB light therapy
LCD Solution with NB-UVB PhototherapyNB-UVB Light Device (311-315 nm)on half of the body will receive LCD while the full body receives NB-UVB therapy
Primary Outcome Measures
NameTimeMethod
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.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 Outcome Measures
NameTimeMethod
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.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.

Trial Locations

Locations (1)

Windsor Dermatology

🇺🇸

East Windsor, New Jersey, United States

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