Plaque PsoriasisPhase 2NCT01166646
Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis
A Phase 2 study testing Halobetasol Proprionate Lotion 0.05% and Halobetasol Proprionate Cream 0.05% in people with Plaque Psoriasis, run by Therapeutics, Inc. at 5 sites in United States.
Trial summary
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. 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?
- Halobetasol Proprionate Lotion 0.05% and Halobetasol Proprionate Cream 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 2
- 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 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
DermResearch Inc.
Austin, Texas, 78759
Dermatology, Laser & Vein Specialists of the Carolinas PLLC
Charlotte, North Carolina, 28207
Michigan Center for Skin Care Research (dba Skin Care Research)
Clinton Township, Michigan, 48038
Therapeutics Clinical Research
San Diego, California, 92123
Somerset Skin Centre
Troy, Michigan, 48084
About this study
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.
- Conditions
- Plaque Psoriasis
- Being tested
- Halobetasol Proprionate Lotion 0.05%, Halobetasol Proprionate Cream 0.05%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol Proprionate Lotion 0.05%Drug
Apply 3.5 grams twice daily for 1-2 weeks
Halobetasol Proprionate Cream 0.05%Drug
Also called Ultravate
Apply 3.5 grams twice daily for 1-2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Halobetasol Proprionate Lotion 0.05% | Experimental | Subjects randomized to receive lotion Receives: Drug: Halobetasol Proprionate Lotion 0.05% |
| Halobetasol Proprionate Cream 0.05% | Active comparator | Subjects randomized to receive cream Receives: Drug: Halobetasol Proprionate Cream 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal Suppression Potential
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.
Measured: After 1-2 weeks dose
Pharmacokinetic Properties (Cmax)
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.
Measured: Day 8
Pharmacokinetic Properties (Tmax)
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.
Measured: Day 8
Pharmacokinetic Properties (AUC)
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.
Measured: Day 8
Secondary outcomes (2)
Changes in Disease Severity (Success)
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).
Measured: Day 15
Number of Subjects Whose Signs of Psoriasis Was Designated "Success"
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).
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
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 Plaque PsoriasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166646
- Sponsor's protocol ID
- 000-0551-202
- Status last verified
- Apr 2016
- First submitted
- 19 Jul 2010
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01166646
- Acronym / sponsor ID
- 000-0551-202
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Posted 16 May 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 investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Halobetasol Proprionate Lotion 0.05% | Experimental | Drug: Halobetasol Proprionate Lotion 0.05%Subjects randomized to receive lotion |
| Halobetasol Proprionate Cream 0.05% | Active comparator | Drug: Halobetasol Proprionate Cream 0.05%Subjects randomized to receive cream |
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 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Halobetasol Proprionate Lotion 0.05%Apply 3.5 grams twice daily for 1-2 weeks | Drug | Halobetasol Proprionate Lotion 0.05% |
| Halobetasol Proprionate Cream 0.05%Also: UltravateApply 3.5 grams twice daily for 1-2 weeks | Drug | Halobetasol Proprionate Cream 0.05% |
Primary outcome
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.
Pharmacokinetic Properties (Cmax)
Time frame: Day 8
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.
Pharmacokinetic Properties (Tmax)
Time frame: Day 8
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.
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.
2 secondary outcomes
Changes in Disease Severity (Success)
Time frame: Day 15
Number of Subjects Whose Signs of Psoriasis Was Designated "Success"
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Halobetasol Proprionate Lotion 0.05% and Halobetasol Proprionate Cream 0.05% in people with Plaque Psoriasis, run by Therapeutics, Inc. at 5 sites 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 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 May 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?
Adrenal Suppression Potential (time frame: After 1-2 weeks dose). The study lists 4 primary outcomes in all. 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 16 May 2016.