Plaque PsoriasisPhase 4NCT01111123
Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis
A Phase 4 study testing Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) in people with Plaque Psoriasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai, Department of Dermatology
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%), Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
- Keywords
- plaque psoriasis, lac-hydrin, ammonium lactate, Ultravate, halobetasol propionate, weekend only application, topical therapy, topical corticosteroid, class I steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)Drug
Steroid on weekends only group
Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointmentDrug
Placebo on weekends only group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only Receives: Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) |
| 2 | Placebo comparator | Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only Receives: Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the maintenance phase, from 2 weeks up to 26 weeks
Secondary outcomes (1)
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.
Measured: During the maintenance phase, from 2 weeks up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason J Emer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111123
- Sponsor's protocol ID
- GCO 08-1061 0001 01 DE
- Status last verified
- May 2016
- First submitted
- 22 Apr 2010
- Last updated
- 24 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21386955
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01111123
- Acronym / sponsor ID
- GCO 08-1061 0001 01 DE
- Conditions
- Plaque Psoriasis
- Keywords
- plaque psoriasis, lac-hydrin, ammonium lactate, Ultravate, halobetasol propionate, weekend only application, topical therapy, topical corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 24 Jun 2016
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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only |
| 2 | Placebo comparator | Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointmentLac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)Steroid on weekends only group | Drug | 1 |
| Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointmentPlacebo on weekends only group | Drug | 2 |
Primary outcome
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.
1 secondary outcome
Signs of Psoriasis, Atrophy or Telangiectasis
Time frame: During the maintenance phase, from 2 weeks up to 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21386955Emer 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.
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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.
Jason J Emer, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) in people with Plaque Psoriasis, run by Icahn School of Medicine at Mount Sinai 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 8 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 24 Jun 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Global Assessment (time frame: During the maintenance phase, from 2 weeks up to 26 weeks). 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 NCT01111123, which also lists 1 linked publication.
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 24 Jun 2016.