Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only |
|
| 2 | Placebo Comparator | Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) | Drug | Steroid on weekends only group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Global Assessment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Signs of Psoriasis, Atrophy or Telangiectasis | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason J Emer, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai, Department of Dermatology | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21386955 | Result | Emer JJ, Frankel A, Sohn A, Lebwohl M. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Ammonium Lactate Lotion 12% and Halobetasol Propionate Ointment 0.05% in the Treatment and Maintenance of Psoriasis. J Clin Aesthet Dermatol. 2011 Feb;4(2):28-39. |
Not provided
Not provided
Patients who were pregnant/nursing, those on biological or other systemic treatments or other systemic treatments in previous three months, those on topical therapies other than emollients in the past one month, those with pre-existing overt atrophy/telangiectasia in treatment areas were excluded.
This trial was conducted at the outpatient clinic of the MSSM Department of Dermatology Clinical Trials Center, in New York, New York, from January 2009 to March 2010. Recruitment was through: advertisements, referrals from the Dermatology Faculty Practice Associates, and through voluntary faculty and dermatology residents.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lac-hydrin + Ultravate | Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks |
| FG001 | Lac Hydrin + Placebo | Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open- Label Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment | Drug | Placebo on weekends only group |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lac-hydrin + Ultravate | Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks |
| BG001 | Lac Hydrin + Placebo | Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Global Assessment | 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. | The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT). | Posted | Number | participants | During the maintenance phase, from 2 weeks up to 26 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Signs of Psoriasis, Atrophy or Telangiectasis | 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. | The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT. | Posted | Number | participants | During the maintenance phase, from 2 weeks up to 26 weeks |
|
|
Adverse events (AEs) were recorded up to the study total of 26 weeks. No follow-up visits were conducted after study treatment concluded.
There were no reported AEs, including serious AEs, related to study medication throughout the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lac-hydrin + Ultravate | Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks | 0 | 21 | 0 | 21 | ||
| EG001 | Lac Hydrin + Placebo | Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks | 0 | 20 | 0 | 20 |
Not provided
Not provided
The maintenance phase did not have a long enough study duration to capture clinically significant changes in disease status in the steroid group since >50 percent of the patients at the end of the 24 weeks still remained in the study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Emer, MD | Mount Siani School of Medicine Department of Dermatology | 2122413288 | 43288 | jason.emer@mssm.edu |
| >=65 years |
|
| Male |
|
|
|