LCD Solution Versus Calcipotriol Cream in the Treatment o... | NCT00705900

Studies
LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis

NCT00705900

Sponsor

NeoStrata Company, Inc.

Status

Completed

Last Update Posted

Nov 19, 2008Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Plaque Psoriasis

Interventions

LCD
calcipotriol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jun 25, 2008

First Submission Date that Met QC Criteria

Jun 26, 2008

First Posted Date

Jun 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2008

Last Update Posted Date

Nov 19, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the safety and effectiveness of a new topical LCD solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	LCD Solution: 2 applications / day	Drug: LCD
2	Active Comparator	Calcipotriol cream: 2 applications / day	Drug: calcipotriol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LCD	Drug	2 applications / day for 12 weeks	1
calcipotriol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms		12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms		Week 12 and Week 18

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
able and willing to provide written informed consent
diagnosed with chronic plaque psoriasis
3% to 15% body surface area involved
in good general health

Exclusion Criteria:

other current treatments for psoriasis
renal or liver dysfunction
pregnant or nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandra B Kimball, MD	Massachusettes General Hospital / Brigham Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mass General Hospital: Clinical Unit for Research Trials in Skin		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20713833	Derived	Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
20513160	Derived

Type	Date	Date Unknown
Release	Nov 17, 2014
Reset	Nov 21, 2014
Release	Apr 1, 2015
Reset	Apr 2, 2015
Release	Apr 17, 2015
Reset	Apr 21, 2015
Release	Jul 22, 2015
Reset	Jul 24, 2015

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 17, 2014			Nov 21, 2014
Apr 1, 2015

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases