PsoriasisPhase 2NCT01610596
A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis
A Phase 2 study testing Halobetasol Propionate Lotion 0.05% in people with Psoriasis and Plaque Psoriasis, run by Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Plaque Psoriasis
- What is being tested?
- Halobetasol Propionate Lotion 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Feb 2012
- 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
- Subject is Male or non-pregnant female; 18 years of age at time of Screening.
- Subject is willing and able to give written informed consent.
- subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than approximately 10% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
- Subject has an Overall Disease Severity (ODS) score for the Treatment Area of at least three (3) at the Baseline Visit.
- If subject is a woman of childbearing potential (WOCBP) , she must have a negative urine pregnancy test (UPT) and agree to use an effective form of birth control for the duration of the study (i.e., abstinence, stabilized on hormonal contraceptives [oral, injectable, transdermal or intravaginal] or IUD for at least three months prior to test article application, condom and a spermicidal, or diaphragm and a 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 form of birth control for the duration of the study.
Who cannot join
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photo-chemotherapy or systemic corticosteroid therapy (such as systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids]) within 30 days prior to the Baseline Visit.
- Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to the Baseline Visit.
- Subject has used any systemic biologic therapy (i.e., FDA approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value.
Show all 17Show fewer
- Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study that is thought by the investigator likely to modify the subject's disease.
- Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the Baseline Visit.
- Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
- Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
- Subject has a history of sensitivity to any of the ingredients in the test article.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
- Subject has been previously enrolled in this study and treated with a test article.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DermResearch, Inc.
Austin, Texas, 78759
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Double-blind, Randomized, Multicenter, Vehicle-Controlled Parallel Group Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.
- Conditions
- Psoriasis, Plaque Psoriasis
- Being tested
- Halobetasol Propionate Lotion 0.05%, Placebo
- Keywords
- Psoriasis, Skin Diseases, Halobetasol, Vasoconstrictor Agents, Therapeutic Uses, Pharmacologic Actions, Anti-Inflammatory Agents, Physiological Effects of Drugs
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol Propionate Lotion 0.05%Drug
Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Halobetasol Propionate Lotion 0.05% | Experimental | Topical lotion, applied twice daily Receives: Drug: Halobetasol Propionate Lotion 0.05% |
| Vehicle Lotion | Placebo comparator | Topical lotion, applied twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease Severity Score (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. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
Measured: Day 15
Secondary outcomes (3)
Percent Body Surface Area
Changes in percent BSA with active psoriasis in the Treatment Area
Measured: Baseline, Days 8 and 15
Clinical Signs and Symptoms of Psoriasis
The proportion of subjects rated a "treatment success" for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. "Treatment success" is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Measured: Days 8 and 15
Overall Disease Severity Score (Improvement)
The proportion of subjects rated a "improved" for ODS at Day 8 and Day 15. "Improvement" is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Measured: Days 8 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Syd Dromgoole, PhD, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610596
- Sponsor's protocol ID
- 000-0551-207
- Status last verified
- Apr 2016
- First submitted
- 18 Jan 2012
- Last updated
- 13 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 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter, Vehicle-Controlled Parallel Group Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
- ClinicalTrials.gov ID
- NCT01610596
- Acronym / sponsor ID
- 000-0551-207
- Conditions
- Psoriasis, Plaque Psoriasis
- Keywords
- Psoriasis, Skin Diseases, Halobetasol, Vasoconstrictor Agents, Therapeutic Uses, Pharmacologic Actions, Anti-Inflammatory Agents, Physiological Effects of Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Halobetasol Propionate Lotion 0.05% | Experimental | Drug: Halobetasol Propionate Lotion 0.05%Topical lotion, applied twice daily |
| Vehicle Lotion | Placebo comparator | Drug: PlaceboTopical lotion, applied twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is Male or non-pregnant female; 18 years of age at time of Screening.
- Subject is willing and able to give written informed consent.
- subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than approximately 10% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
- Subject has an Overall Disease Severity (ODS) score for the Treatment Area of at least three (3) at the Baseline Visit.
Key exclusion criteria (17 listed)
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photo-chemotherapy or systemic corticosteroid therapy (such as systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids]) within 30 days prior to the Baseline Visit.
- Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to the Baseline Visit.
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 Propionate Lotion 0.05%Apply twice daily for 1-2 weeks, not to exceed 50 grams per week | Drug | Halobetasol Propionate Lotion 0.05% |
| Placebo | Drug | Vehicle Lotion |
Primary outcome
Overall Disease Severity Score (Success)
Time frame: Day 15
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. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
3 secondary outcomes
Percent Body Surface Area
Time frame: Baseline, Days 8 and 15
Clinical Signs and Symptoms of Psoriasis
Time frame: Days 8 and 15
Overall Disease Severity Score (Improvement)
Time frame: Days 8 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Syd Dromgoole, PhD study director
Therapeutics, Inc.
3 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 Propionate Lotion 0.05% in people with Psoriasis and Plaque Psoriasis, run by Therapeutics, Inc. at 3 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 6 inclusion and 17 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 13 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 3 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. 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 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 11 Apr 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?
Overall Disease Severity Score (Success) (time frame: Day 15). 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 13 May 2016.