- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166646
Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis
April 11, 2016 updated by: Therapeutics, Inc.
The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Therapeutics Clinical Research
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Michigan
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Clinton Township, Michigan, United States, 48038
- Michigan Center for Skin Care Research (dba Skin Care Research)
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Troy, Michigan, United States, 48084
- Somerset Skin Centre
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Dermatology, Laser & Vein Specialists of the Carolinas PLLC
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Texas
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Austin, Texas, United States, 78759
- DermResearch Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects are male or non-pregnant female; 18 years of age at the time of screening.
- Subjects provide Institutional Review Board (IRB) approved written informed consent for participating in this study.
- Subjects have a clinical diagnosis of stable plaque psoriasis involving a minimum of 20% body surface area and an Overall Disease Severity (ODS) score on the designated treatment area of at least 3 as determined by the evaluating investigator.
- Subjects are willing and able to apply the study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening (Part B) and Baseline Visits and agree to use an effective form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives or contraceptive patches for at least three months, implant, injection, IUD, NuvaRing®, condom and spermicidal or diaphragm and spermicidal). Abstinence is an acceptable form of birth control for subjects who are not sexually active. Subjects who become sexually active during the trial must agree to use an effective, non-prohibited form of birth control for the duration of the study.
Exclusion Criteria:
- Subjects have spontaneously improving or rapidly deteriorating plaque psoriasis, or have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subjects have a physical condition which, in the Investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
- Subjects have used any phototherapy (including laser), photo-chemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of study medication treatment.
- Subjects have used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or subjects have used systemic or topical corticosteroids between the Screening Visit and the initiation of treatment.
- Subjects have had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or are intending to have such exposure during the study that is thought by the Investigator to likely modify the subject's disease.
- Subjects have used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of study medication treatment.
- Subjects have used emollients/moisturizers on areas to be treated within one day prior to the initiation of study medication treatment.
- Subjects are currently using lithium or plaquenil.
- Subjects are currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitors at a dose that has not been stabilized, in the opinion of the Investigator.
- Subjects have a history of sensitivity to any of the ingredients in the study medication.
- Subjects are pregnant, nursing or planning a pregnancy during the study period.
- Subjects are currently enrolled in an investigational drug or device study.
- Subjects have received an investigational drug or an investigational device within 30 days prior to screening.
- Subjects have been previously enrolled in this study and treated with the study medication.
- Subjects have irregular sleep schedules or work night shifts (cortisol levels exhibit physiological diurnal variation).
- Subjects have a screening CST with a post 30-minute stimulation cortisol level of ≤ 18 µg/dL.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Halobetasol Proprionate Lotion 0.05%
Subjects randomized to receive lotion
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Apply 3.5 grams twice daily for 1-2 weeks
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Active Comparator: Halobetasol Proprionate Cream 0.05%
Subjects randomized to receive cream
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Apply 3.5 grams twice daily for 1-2 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adrenal Suppression Potential
Time Frame: After 1-2 weeks dose
|
Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal.
An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.
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After 1-2 weeks dose
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Pharmacokinetic Properties (Cmax)
Time Frame: Day 8
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Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
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Day 8
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Pharmacokinetic Properties (Tmax)
Time Frame: Day 8
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Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
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Day 8
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Pharmacokinetic Properties (AUC)
Time Frame: Day 8
|
Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
|
Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Disease Severity (Success)
Time Frame: Day 15
|
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale.
ODS evaluations will be dichotomized to "success" and "failure" with success defined as a grade of 1 or 0 at the end of treatment (EOT).
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Day 15
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Number of Subjects Whose Signs of Psoriasis Was Designated "Success"
Time Frame: Day 15
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Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale.
Each of the signs of psoriasis will be dichotomized to a) "success" and "failure" with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period).
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Day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (Estimate)
July 21, 2010
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
April 11, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000-0551-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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