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Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:
NCT00769184
First received: October 7, 2008
Last updated: April 20, 2009
Last verified: April 2009
History of Changes
  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: clobetasol + LCD
Drug: Clobetasol + Placebo

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:

MedlinePlus related topics: Psoriasis Steroids
U.S. FDA Resources

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

Primary Outcome Measures:
  • Proportion of patients who are clear (PGA score 0) or have minimal disease (PGA score 1) on each treated side at each visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in disease severity (using PGA score, erythema, scaling, induration, and overall severity scores of target lesions, %BSA involvement, and patient self-assessment of psoriasis symptoms) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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: 1
corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)
 Drug: clobetasol + LCD
clobetasol: 2 applications / day LCD Solution: 2 applications / day
Placebo Comparator: 2
steroid + placebo treatment (2 weeks), placebo alone treatment (4 weeks)
 Drug: Clobetasol + Placebo
Clobetasol: 2 applications / day Placebo Solution: 2 applications / day

  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
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.
  More Information

No publications provided

Responsible Party: Barbara Green, NeoStrata Company, Inc.
ClinicalTrials.gov Identifier: NCT00769184     History of Changes
Other Study ID Numbers: 08-LCDSTRD
Study First Received: October 7, 2008
Last Updated: April 20, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013