Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis - Full Text View

Sponsor:	NeoStrata Company, Inc.
Information provided by:	NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:	NCT00769184

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Drug Information available for: Clobetasol Clobetasol propionate

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
1: Experimental corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)	Drug: clobetasol + LCD clobetasol: 2 applications / day LCD Solution: 2 applications / day
2: Placebo Comparator 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:	NeoStrata Company, Inc. ( Barbara Green )
Study ID Numbers:	08-LCDSTRD
Study First Received:	October 7, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00769184 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by NeoStrata Company, Inc.:

chronic plaque psoriasis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010