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
  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:


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
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.
  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 September 18, 2014