- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111123
Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis
May 25, 2016 updated by: Icahn School of Medicine at Mount Sinai
A Randomized, Double-blind Study to Evaluate the Efficacy of Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis.
The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis.
Patients will use both medications continuously for two weeks and those who obtain a good improvement based on investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24 more weeks.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized, double-blind, placebo-controlled, clinical trial assessing the efficacy of Ultravate ointment in combination with Lac-Hydrin lotion in the treatment of plaque psoriasis.
In the first phase, patients will be treated for two weeks with combination therapy using Ultravate ointment twice daily along with Lac-Hydrin lotion twice daily.
After two weeks, psoriasis plaques will be evaluated to test treatment efficacy.
Those patients with a significant clinical improvement per investigator clinical assessments, will be randomized in a 1:1 fashion into a maintenance phase and receive Lac-Hydrin lotion twice daily everyday with placebo ointment or Ultravate ointment twice daily on weekends only.
Continuous use of Ultravate ointment will be discontinued following two weeks of treatment in compliance with its FDA indication.
Patients will be evaluated every 4 weeks (monthly) through the maintenance phase.
The purpose of this second phase of the study is to investigate whether use of Ultravate on weekends only can minimize risk of plaque recurrence, maximize duration of therapeutic effect, while limiting the need for the use of long-term continuous topical corticosteroid treatment.
As well, the second phase of the study is to investigate whether twice daily Lac-Hydrin lotion has an impact in maximizing the duration of therapeutic effect as well as minimizing local cutaneous side effects such as skin atrophy and telangiectasia.
Part of this clinical study consists of the use of patient and self-assessment questionnaires and the use of non-identifying digital photography of target lesions.
The hypothesis is that Ultravate ointment on weekends only will be statistically more efficacious at maintaining an excellent initial clinical response and its combination with Lac-Hydrin lotion will help to minimize any local cutaneous side effects as well as enhance its therapeutic effect.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 4
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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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai, Department of Dermatology
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
- Females of childbearing potential must have a negative urine pregnancy test on Day 1 and must agree to use adequate birth control methods during the entire study.
- A clear diagnosis of plaque psoriasis must have been previously established and the disease must have been present at least 6 months.
- Subjects must have lesions suitable for evaluating response to test agents. The severity of the disease at Day 1 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation).
- Subjects must be able to understand the requirements of the study, abide by the restrictions, and return for the required examinations. All subject must sign the statement of informed consent approved for the study.
Exclusion Criteria:
- Subjects who are pregnant (determined from a urine pregnancy test on Day 1).
- Subjects who are nursing.
- Subjects with known hypersensitivity to any components of the test medication.
- Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines).
- Subjects using biologics or any other systemic treatment for psoriasis within 12 weeks of entering the study.
- Subjects using systemic corticosteroids within 28 days of entering the study; subjects using topical corticosteroids or other topical therapies (other than emollients) at any location on the body within 1 week of entering the study.
- Subjects with overt pre-existing telangiectasia or skin atrophy at intended treatment sites.
- Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only
|
Steroid on weekends only group
|
Placebo Comparator: 2
Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only
|
Placebo on weekends only group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Global Assessment
Time Frame: During the maintenance phase, from 2 weeks up to 26 weeks
|
Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.
|
During the maintenance phase, from 2 weeks up to 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Signs of Psoriasis, Atrophy or Telangiectasis
Time Frame: During the maintenance phase, from 2 weeks up to 26 weeks
|
Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.
|
During the maintenance phase, from 2 weeks up to 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jason J Emer, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
April 22, 2010
First Submitted That Met QC Criteria
April 23, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Estimate)
June 24, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 08-1061 0001 01 DE
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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