Chronic Plaque PsoriasisNCT00705900
LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis
A study testing LCD and calcipotriol in people with Chronic Plaque Psoriasis, run by NeoStrata Company, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- LCD and calcipotriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other current treatments for psoriasis
- renal or liver dysfunction
- pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Mass General Hospital: Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis
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.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- LCD, calcipotriol
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCDDrug
2 applications / day for 12 weeks
calcipotriolDrug
Also called Dovonex Cream (50 mcg/g 0.005%)
2 applications / day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LCD Solution: 2 applications / day Receives: Drug: LCD |
| 2 | Active comparator | Calcipotriol cream: 2 applications / day Receives: Drug: calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms
Measured: 12 weeks of treatment
Secondary outcomes (1)
Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms
Measured: Week 12 and Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoStrata Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandra B Kimball, MD, Principal investigator, Massachusettes General Hospital / Brigham Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705900
- Sponsor's protocol ID
- 06-LCDPOP
- Status last verified
- Nov 2008
- First submitted
- 25 Jun 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20713833Alora-Palli MB, Perkins AC, Van Cott A, Kimball AB. Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream. Am J Clin Dermatol. 2010;11(4):275-83. doi: 10.2165/11530380-000000000-00000.
PubMed 20513160
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00705900
- Acronym / sponsor ID
- 06-LCDPOP
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NeoStrata Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LCDLCD Solution: 2 applications / day |
| 2 | Active comparator | Drug: calcipotriolCalcipotriol cream: 2 applications / day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- other current treatments for psoriasis
- renal or liver dysfunction
- pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCD2 applications / day for 12 weeks | Drug | 1 |
| calcipotriolAlso: Dovonex Cream (50 mcg/g 0.005%)2 applications / day for 12 weeks | Drug | 2 |
Primary outcome
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms
Time frame: 12 weeks of treatment
1 secondary outcome
Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms
Time frame: Week 12 and Week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
- Derived from this study: PubMed 20713833Alora-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.
- Derived from this study: PubMed 20513160Alora-Palli MB, Perkins AC, Van Cott A, Kimball AB. Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream. Am J Clin Dermatol. 2010;11(4):275-83. doi: 10.2165/11530380-000000000-00000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra B Kimball, MD principal investigator
Massachusettes General Hospital / Brigham Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCD and calcipotriol in people with Chronic Plaque Psoriasis, run by NeoStrata Company, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008.