PsoriasisPhase 1TachyphylaxisNCT01404338
Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
A Phase 1 study testing Halobetasol 0.05% ointment in people with Psoriasis, run by Patel, Rita Vikram, M.D..
Trial summary
Tachyphylaxis occurs when a medication is applied multiple times and a decreased response takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Halobetasol 0.05% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Baseline/Week 0 and must agree to use adequate birth control methods during the entire study (a barrier method i.e. condoms, diaphragm; hormonal contraceptives i.e. birth control pills, implants, or injections; intrauterine device, or abstinence).
- Subjects must be diagnosed with stable plaque psoriasis affecting 1% to 10% body surface area (excluding the face, scalp, groin, axillae or other intertriginous areas).
- Subjects receiving phototherapy for their psoriasis.
- Subjects must have at least two symmetrical lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Week 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation) on the Target Lesion Severity Score.
- Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.
Who cannot join
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with known hypersensitivity to any components of the test medication.
- Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
- Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
- Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
- Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
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- Subjects using systemic corticosteroids within 28 days of entering the study
- Subjects using topical corticosteroids or other topical therapies (other than emollients) at the treatment area locations within 14 days of entering the study
- Subjects using phototherapy (UVB, PUVA) on target treatment sites within 4 weeks of entering the study.
- Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (treatment areas).
- 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.
About this study
Official title: An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
Tachyphylaxis occurs when a medication is applied multiple times and a decreased response takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by using topical steroids in the psoriasis patient population. The investigators are looking to enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be occluded with a band aid for a one week period. Weekly, the investigators will inspect the plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however, both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be measured.
- Conditions
- Psoriasis
- Being tested
- Halobetasol 0.05% ointment, Placebo Ointment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol 0.05% ointmentDrug
Placebo OintmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | 1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week Receives: Drug: Halobetasol 0.05% ointment |
| Vehicle Arm | Placebo comparator | Vehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week Receives: Drug: Placebo Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tachyphylaxis
Phase 1: %change in TLSS of target lesion versus comparator lesion Phase 2a, after an interim discontinuation period of 4-8 weeks: %change in TLSS of target lesion versus comparator lesion Phase 2b, after an interim discontinuation period of 4-8 weeks: Percent change in TLSS of the comparator lesion (now switched to open-label halobetasol 0.05% ointment) versus target lesion
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patel, Rita Vikram, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404338
- Sponsor's protocol ID
- 11-0422
- Acronym
- Tachyphylaxis
- Status last verified
- Jul 2011
- First submitted
- 25 Jul 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT01404338
- Acronym / sponsor ID
- Tachyphylaxis / 11-0422
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Patel, Rita Vikram, M.D.
- Study start
- Jun 2011
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tachyphylaxis occurs when a medication is applied multiple times and a decreased response takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by using topical steroids in the psoriasis patient population. The investigators are looking to enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be occluded with a band aid for a one week period. Weekly, the investigators will inspect the plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however, both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Drug: Halobetasol 0.05% ointment1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week |
| Vehicle Arm | Placebo comparator | Drug: Placebo OintmentVehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 Baseline/Week 0 and must agree to use adequate birth control methods during the entire study (a barrier method i.e. condoms, diaphragm; hormonal contraceptives i.e. birth control pills, implants, or injections; intrauterine device, or abstinence).
- Subjects must be diagnosed with stable plaque psoriasis affecting 1% to 10% body surface area (excluding the face, scalp, groin, axillae or other intertriginous areas).
- Subjects receiving phototherapy for their psoriasis.
- Subjects must have at least two symmetrical lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Week 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation) on the Target Lesion Severity Score.
Key exclusion criteria (11 listed)
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with known hypersensitivity to any components of the test medication.
- Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
- Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
- Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
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 0.05% ointment | Drug | Active Arm |
| Placebo Ointment | Drug | Vehicle Arm |
Primary outcome
Time to Tachyphylaxis
Time frame: 4 Weeks
Phase 1: %change in TLSS of target lesion versus comparator lesion Phase 2a, after an interim discontinuation period of 4-8 weeks: %change in TLSS of target lesion versus comparator lesion Phase 2b, after an interim discontinuation period of 4-8 weeks: Percent change in TLSS of the comparator lesion (now switched to open-label halobetasol 0.05% ointment) versus target lesion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Halobetasol 0.05% ointment in people with Psoriasis, run by Patel, Rita Vikram, M.D..
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 11 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 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Tachyphylaxis (time frame: 4 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 28 Jul 2011.