Stable Plaque PsoriasisPhase 4NCT00990561
Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis
A Phase 4 study testing Ultravate ointment twice daily + LacHydrin lotion twice daily and Ultravate ointment once daily + LacHydrin lotion twice daily in people with Stable Plaque Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stable Plaque Psoriasis
- What is being tested?
- Ultravate ointment twice daily + LacHydrin lotion twice daily and Ultravate ointment once daily + LacHydrin lotion twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically diagnosed by an investigator to have stable plaque psoriasis with no more than 10% body surface area involvement.
- A subject must have an overall baseline score of 6 (moderate) or greater based on a twelve-point scale on the Psoriasis Severity Assessment (PSA) form. Elevation, erythema, and scale will each be graded on a four point scale with a maximum total of 12 points. Each of these 3 variables should be scored as at least a two. (Plaque elevation is defined as the total elevation, including adherent scales, relative to the surrounding skin).
- For female patients of childbearing potential, a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
- Negative urine pregnancy test at the time of study entry (for female patients of childbearing potential).
- Written, informed consent and photographic release.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- A female subject who is pregnant, nursing an infant or planning a pregnancy during the study (throughout the course of the study, women of childbearing potential must use reliable forms of contraception [i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives].
- A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject with the presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- A subject that has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
- A subject with spontaneously improving or rapidly deteriorating plaque psoriasis.
- A subject with pustular or erythrodermic psoriasis.
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- A subject diagnosed by an investigator to have stable plaque psoriasis involvement that exceeds more than 10% of the subject's body surface area.
- Use of systemic agents such as oral retinoids, methotrexate, cyclosporine or systemic corticosteroids within four weeks prior to study entry.
- Use of biologic agents such as alefacept, infliximab, efalizumab, adalimumab, or etanercept within four weeks prior to study entry.
- Use of topical drugs that might alter the course of psoriasis (e.g., corticosteroids, retinoids, vitamin D analogues, salicylic acid, tacrolimus, tar and anthralin,) or has received Ultraviolet B treatment within two weeks prior to study entry.
- Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
- A subject with a known sensitivity to any of the study treatments and/or their components.
- A subject who will require excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.
- A subject who anticipates a need to use other topical or systemic therapy that might alter the course of psoriasis.
- A subject who anticipates the need for surgery or hospitalization during the study.
- Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: A Clinical Study Comparing the Efficacy of Ultravate Ointment Once Daily vs. Twice Daily in Combination With Lac-Hydrin Lotion in the Treatment of Stable Plaque Psoriasis
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.
- Conditions
- Stable Plaque Psoriasis
- Being tested
- Ultravate ointment twice daily + LacHydrin lotion twice daily, Ultravate ointment once daily + LacHydrin lotion twice daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultravate ointment twice daily + LacHydrin lotion twice dailyDrug
Also called Halobetasol ointment, Ammonium lactate lotion
Topical corticosteroid
Ultravate ointment once daily + LacHydrin lotion twice dailyDrug
Also called Halobetasol ointment, Ammonium lactate lotion
Topical corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Twice Daily Ultravate | Active comparator | Patients will apply both Ultravate ointment and LacHydrin lotion twice daily Receives: Drug: Ultravate ointment twice daily + LacHydrin lotion twice daily |
| Once daily Ultravate | Active comparator | Patients will apply Ultravate ointment once daily, but will use LacHydrin lotion twice daily Receives: Drug: Ultravate ointment once daily + LacHydrin lotion twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Psoriasis Area Severity Index (PASI) Score
PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 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.
- Other trials for Stable Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tina Bhutani, MD, Study director, UCSF Clinical Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990561
- Sponsor's protocol ID
- Ultravate Lac-Hydrin Ranbaxy
- Other IDs
- H5939-34434-01
- Status last verified
- Dec 2018
- First submitted
- 5 Oct 2009
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Efficacy of Ultravate Ointment Once Daily vs. Twice Daily in Combination With Lac-Hydrin Lotion in the Treatment of Stable Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00990561
- Acronym / sponsor ID
- Ultravate Lac-Hydrin Ranbaxy
- Conditions
- Stable Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 5 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twice Daily Ultravate | Active comparator | Drug: Ultravate ointment twice daily + LacHydrin lotion twice dailyPatients will apply both Ultravate ointment and LacHydrin lotion twice daily |
| Once daily Ultravate | Active comparator | Drug: Ultravate ointment once daily + LacHydrin lotion twice dailyPatients will apply Ultravate ointment once daily, but will use LacHydrin lotion twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically diagnosed by an investigator to have stable plaque psoriasis with no more than 10% body surface area involvement.
- A subject must have an overall baseline score of 6 (moderate) or greater based on a twelve-point scale on the Psoriasis Severity Assessment (PSA) form. Elevation, erythema, and scale will each be graded on a four point scale with a maximum total of 12 points. Each of these 3 variables should be scored as at least a two. (Plaque elevation is defined as the total elevation, including adherent scales, relative to the surrounding skin).
- For female patients of childbearing potential, a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
- Negative urine pregnancy test at the time of study entry (for female patients of childbearing potential).
- Written, informed consent and photographic release.
Key exclusion criteria (16 listed)
- A female subject who is pregnant, nursing an infant or planning a pregnancy during the study (throughout the course of the study, women of childbearing potential must use reliable forms of contraception [i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives].
- A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject with the presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- A subject that has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
- A subject with spontaneously improving or rapidly deteriorating plaque psoriasis.
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 |
|---|---|---|
| Ultravate ointment twice daily + LacHydrin lotion twice dailyAlso: Halobetasol ointment, Ammonium lactate lotionTopical corticosteroid | Drug | Twice Daily Ultravate |
| Ultravate ointment once daily + LacHydrin lotion twice dailyAlso: Halobetasol ointment, Ammonium lactate lotionTopical corticosteroid | Drug | Once daily Ultravate |
Primary outcome
Change in Modified Psoriasis Area Severity Index (PASI) Score
Time frame: 2 weeks
PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Tina Bhutani, MD study director
UCSF Clinical Fellow
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 Ultravate ointment twice daily + LacHydrin lotion twice daily and Ultravate ointment once daily + LacHydrin lotion twice daily in people with Stable Plaque Psoriasis, run by University of California, San Francisco 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 6 inclusion and 16 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 4 Jan 2019. 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.
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 5 Dec 2012). 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?
Change in Modified Psoriasis Area Severity Index (PASI) Score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2019.