Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:
NCT00769184
First received: October 7, 2008
Last updated: July 22, 2015
Last verified: July 2015
  Purpose

This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.


Condition Intervention
Psoriasis
Drug: Corticosteroid
Other: Placebo
Drug: LCD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study.

Resource links provided by NLM:


Further study details as provided by NeoStrata Company, Inc.:

Primary Outcome Measures:
  • Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. [ Time Frame: Weeks 2, 6, & 12. ] [ Designated as safety issue: No ]
    Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.


Secondary Outcome Measures:
  • Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions [ Time Frame: Weeks 2, 6, & 12 ] [ Designated as safety issue: No ]
    Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.


Enrollment: 15
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticosteroid + LCD
corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)
Drug: Corticosteroid

One side of body:

clobetasol: 2 applications / day along with LCD application 2 applications/day

Other Name: clobetasol
Drug: LCD

One side of body:

LCD Solution: 2 applications / day along with clobetasol 2 applications/day

Other Name: liquor carbonis distillate
Placebo Comparator: Corticosteroid + Placebo
corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks)
Drug: Corticosteroid

One side of body:

clobetasol: 2 applications / day along with LCD application 2 applications/day

Other Name: clobetasol
Other: Placebo

One side of body:

Placebo Solution: 2 applications / day along with clobetasol 2 applications/day


Detailed Description:

Superpotent topical corticosteroids such as clobetasol propionate are highly effective in treating plaque psoriasis but are not indicated for long term use due to their side effects. Therefore, steroid-sparing combination and sequential regimens, in which the corticosteroid gets supplemented with a non-steroid medication, such as calcipotriol or tazarotene, have become the standard of care, especially in the management of localized psoriasis lesions. A new steroid-free 15% liquor carbonis distillate (LCD) solution (Psorent) was recently found to be more successful than 0.005% calcipotriol cream (Dovonex) at improving and delaying worsening of psoriasis symptoms in a controlled clinical trial. The goal of this pilot study is to evaluate if this LCD solution can be used in combination with acute topical corticosteroid therapy as a new steroid-sparing / enhancing regimen. We hope to explore the compatibility, patient tolerability, and clinical benefit of using LCD solution during and after treatment with clobetasol propionate in adults with moderate to severe plaque psoriasis. This is a randomized, double-blind, vehicle-controlled, bilateral study. Men and women 18 years of age or older, with chronic plaque psoriasis affecting less than or equal to 10% body surface area (BSA) in areas other than the scalp, face, palms, soles, axillae, and groin, are recruited. Those with a Physician Global Assessment (PGA) score greater than 3 and are in general good health will qualify as candidates. On one side of the body, LCD solution and clobetasol propionate will be administered twice daily for the first 2 weeks of treatment, followed by 4 weeks of LCD solution only, followed by 6 weeks of no treatment. On the second half of the body, subject will apply a vehicle solution and clobetasol propionate twice daily for the first 2 weeks, only the vehicle solution twice daily for the next four weeks, and then no treatment for the next 6 weeks. Subjects will be evaluated at weeks 2, 4, 6, 8, 10 and 12. investigators will use the PGA scale [Clear (0) - Severe (5)] to determine treatment effects as well as Target Lesion assessments of Erythema, Scaling, Induration and overall severity [None (0) - Very Severe (4)]. patients will also be required to complete Self-Assessment questionnaires on their psoriasis [None (0) - Severe (6)]. as well as an assessment of the study solution [Excellent (9) - Poor (1)]. . Photographs will be taken at each study visit and adverse events will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • able to provide written informed consent
  • able to attend study visits, apply medications, and follow instructions
  • moderate to severe localized plaque psoriasis lesions (<10% BSA on each side of the body)

Exclusion Criteria:

  • other current treatments for psoriasis
  • hypersensitivity to steroids, liquor carbonis detergens, alcohol, fragrance
  • pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769184

Locations
United States, New Jersey
Windsor Dermatology
East Windsor, New Jersey, United States, 08520
Sponsors and Collaborators
NeoStrata Company, Inc.
Investigators
Principal Investigator: Jerry Bagel, MD Psoriasis Treatment Center of Central New Jersey
  More Information

No publications provided

Responsible Party: NeoStrata Company, Inc.
ClinicalTrials.gov Identifier: NCT00769184     History of Changes
Other Study ID Numbers: 08-LCDSTRD
Study First Received: October 7, 2008
Results First Received: November 14, 2014
Last Updated: July 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by NeoStrata Company, Inc.:
chronic plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015