Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

NCT00769184 | Completed Results DMC

• 1 other identifier: 08-LCDSTRD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

chronic plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.

  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.

  Weeks 2, 6, & 12.

Secondary Outcomes (1)

• Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions

  Weeks 2, 6, & 12

Study Arms (2)

Corticosteroid + LCD

EXPERIMENTAL

corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)

Drug: Corticosteroid; Drug: LCD

Corticosteroid + Placebo

PLACEBO COMPARATOR

corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks)

Drug: Corticosteroid; Other: Placebo

Interventions

Corticosteroid DRUG

One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day

Also known as: clobetasol

Corticosteroid + LCD; Corticosteroid + Placebo

Placebo OTHER

One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day

Corticosteroid + Placebo

LCD DRUG

One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day

Also known as: liquor carbonis distillate

Corticosteroid + LCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• other current treatments for psoriasis
• hypersensitivity to steroids, liquor carbonis detergens, alcohol, fragrance
• pregnant or nursing

Sponsors & Collaborators

• NeoStrata Company, Inc.: lead

Study Sites (1)

Windsor Dermatology

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adrenal Cortex Hormones; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This was a bilateral study in which 15 subjects total were recruited and randomized to receive both interventions simultaneously by dividing treatment arms to each side of the body.

Results Point of Contact

• Title: Barbara Green, RPH, MS
• Organization: NeoStrata Co., Inc.

bgreen@neostrata.com

(609) 520-0715

Study Officials

• Jerry Bagel, MD

  Psoriasis Treatment Center of Central New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 19, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-07

Locations

US (1)