Plaque PsoriasisPhase 3NCT00927069
Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
A Phase 3 study testing Adalimumab every other week and Adalimumab Every Week in people with Plaque Psoriasis, run by Innovaderm Research Inc. at 12 sites in Canada.
Trial summary
This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Adalimumab every other week and Adalimumab Every Week
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 12 sitesCanada
- Study dates
- Mar 2007to Dec 2008
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with plaque psoriasis with documentation of an unsatisfactory response to etanercept as defined by either:
- Failure to present a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week OR;
- Failure to present a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week followed by a dose reduction to 50 mg once a week. To be eligible these patients must have reached a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week followed by a loss of PGA of clear or almost clear at anytime after a dose reduction to 50 mg of etanercept once a week.
- Subject presents a PGA of 3 or more at baseline visit.
- Subject with plaque psoriasis at screening that is severe enough to be candidate for systemic therapy.
- Subject is 18 to 80 years of age .
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- Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
- condoms, sponge, foams, jellies, diaphragm or IUD;
- contraceptives (oral or parenteral) for three months prior to study drug administration;
- a vasectomized partner;
- Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening visit.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, and CXR performed at Screening.
- Subjects will be evaluated for latent TB infection with a PPD test and CHX. Subjects who demonstrate evidence of latent TB infection (either PPD more than or equal to 5 mm of induration, irrespective of BCG vaccination status and negative CXR findings for active TB, and/or suspicious CXR findings will not be allowed to participate in the study.
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
Who cannot join
- Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis or with subject's safety.
- Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex (a component of the pre-filled syringe).
- Subject who has used topical treatments in the last 4 weeks of the etanercept treatment period when the response to etanercept was evaluated as unsatisfactory must use the same topical therapy with the same agents applied in the same manner and with the same application frequency for two weeks prior to the baseline visit as well as during the entire trial. The use of any other topical treatment for psoriasis is prohibited except for allowed treatments.
- Subject who has used UVB phototherapy, excessive sun exposure, phototherapy or any non-biological systemic therapy for the treatment of psoriasis less than 30 days before day 0. Investigational chemical agents must be discontinued at least 30 days or 5 half-lives prior to the Baseline visit (whichever is longer).
- Subject who has used any biological therapy (apart from etanercept) for the treatment of psoriasis less than 3 months (90 days) before day 0. Etanercept must be discontinued before baseline but a washout period is not required.
- Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
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- Subjects for whom documentation of unsatisfactory response to etanercept was obtained while the subject was under combination treatment with any of the following: UVB phototherapy, PUVA therapy, prednisone, methotrexate, acitretin, cyclosporine or any other systemic or biologic drug (apart from etanercept).
- Subject has a poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent stroke and any other condition which, in the opinion of the investigator, would put the subject at risk if participating in the study.
- Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
- Subject has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Subject has a history of listeriosis, treated or untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
- Subject who has received any live attenuated vaccine 28 days or less before baseline.
- Subject with hepatitis B or hepatitis C viral infection.
- Subject with any of the following: hemoglobin ≤ 10 g/L, white blood cells ≤ 3.0 X 109/L, platelet counts ≤130 X 109/L, ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 mmol/L.
- Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- Subject is known to have immune deficiency or is immunocompromised.
- Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication.
- Subject has a history of clinically significant drug or alcohol abuse in the last year.
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Innovaderm Research Laval Inc.
Laval, Quebec, H7S 2C6
Mediprobe Research
London, Ontario, N5X 2P1
The Guenther Dermatology Research center
London, Ontario, N6A 3H7
Lynderm Research
Markham, Ontario, L3P 1A8
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Entralogix Inc.
Oakville, Ontario, L6K 1E1
Centre de Recherche Clinique Martin Gilbert inc et Centre Dermatologie Maizerets
Québec, Quebec, G1J 1X7
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1C 2H5
Centre de Recherches Dermatologiques du Quebec Metropolitain
Ste-Foy, Quebec, G1V 4X7
Entralogix Clinical Group Inc.
Toronto, Ontario, M4V 1R1
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: Open Label Study to Evaluate the Efficacy and Safety of Adalimumab in Patients With Plaque Psoriasis Who Showed an Unsatisfactory Response to Etanercept
This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.
Read the detailed description
A total of 50 patients with psoriasis vulgaris who showed an unsatisfactory response to etanercept 50 mg twice a week followed by 50 mg once a week and a total of 50 patients who showed an unsatisfactory response to etanercept 50 mg twice a week without dose reduction will be recruited. All patients will receive adalimumab 40 mg every other week (EOW) for 12 weeks. Patients who fail to reach a physician's global assessment (PGA) of clear or almost clear at week 12 will have an increase in adalimumab to 40 mg every week (EW) for an additional 12 weeks. Patients who reach a PGA of clear or almost clear at week 12 will continue to receive adalimumab at 40 mg EOW for an additional 12 weeks. Patients will be evaluated for safety and efficacy every 4 weeks for a total of 24 weeks. PASI, BSA and PGA will be performed at each visit. Routine chemistry, hematology and urinalysis will be performed every 4 weeks.
The percentage of patients achieving a physician's global assessment (PGA) of clear or almost clear after at least 12 weeks of adalimumab will be calculated for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week without dose reduction as well as for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week followed by 50 mg once a week.
A physician's global assessment (PGA) of clear is defined by no plaque elevation over normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
A physician's global assessment (PGA) of almost clear is defined as follows: It is possible but difficilt to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a definite red coloration.
- Conditions
- Plaque Psoriasis
- Being tested
- Adalimumab every other week, Adalimumab Every Week
- Keywords
- Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab every other weekDrug
Also called HUMIRA
Adalimumab 40mg injection every other week for 24 weeks
Adalimumab Every WeekDrug
Also called HUMIRA
Adalimumab 40mg injection every week for the last 12 weeks of study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. Receives: Drug: Adalimumab every other week |
| Group B | Experimental | Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening. Receives: Drug: Adalimumab every other week |
| Group A dose increase at Week 12 | Experimental | Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. Receives: Drug: Adalimumab Every Week |
| Group B dose increase at Week 12 | Experimental | Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. Receives: Drug: Adalimumab Every Week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Measured: 12 weeks
Secondary outcomes (4)
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Measured: 12 weeks
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Measured: 24 weeks
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Measured: 24 weeks
Total Number of Adverse Events for All Patients in the Study.
Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionDec 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927069
- Sponsor's protocol ID
- Inno-6002
- Status last verified
- Sep 2011
- First submitted
- 22 Jun 2009
- Last updated
- 9 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate the Efficacy and Safety of Adalimumab in Patients With Plaque Psoriasis Who Showed an Unsatisfactory Response to Etanercept
- ClinicalTrials.gov ID
- NCT00927069
- Acronym / sponsor ID
- Inno-6002
- Conditions
- Plaque Psoriasis
- Keywords
- Adalimumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Abbott
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 24 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.
Detailed description
A total of 50 patients with psoriasis vulgaris who showed an unsatisfactory response to etanercept 50 mg twice a week followed by 50 mg once a week and a total of 50 patients who showed an unsatisfactory response to etanercept 50 mg twice a week without dose reduction will be recruited. All patients will receive adalimumab 40 mg every other week (EOW) for 12 weeks. Patients who fail to reach a physician's global assessment (PGA) of clear or almost clear at week 12 will have an increase in adalimumab to 40 mg every week (EW) for an additional 12 weeks. Patients who reach a PGA of clear or almost clear at week 12 will continue to receive adalimumab at 40 mg EOW for an additional 12 weeks. Patients will be evaluated for safety and efficacy every 4 weeks for a total of 24 weeks. PASI, BSA and PGA will be performed at each visit. Routine chemistry, hematology and urinalysis will be performed every 4 weeks.
The percentage of patients achieving a physician's global assessment (PGA) of clear or almost clear after at least 12 weeks of adalimumab will be calculated for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week without dose reduction as well as for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week followed by 50 mg once a week.
A physician's global assessment (PGA) of clear is defined by no plaque elevation over normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
A physician's global assessment (PGA) of almost clear is defined as follows: It is possible but difficilt to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a definite red coloration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Adalimumab every other weekPatients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. |
| Group B | Experimental | Drug: Adalimumab every other weekPatients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening. |
| Group A dose increase at Week 12 | Experimental | Drug: Adalimumab Every WeekPatients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. |
| Group B dose increase at Week 12 | Experimental | Drug: Adalimumab Every WeekPatients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject with plaque psoriasis with documentation of an unsatisfactory response to etanercept as defined by either:
- Subject presents a PGA of 3 or more at baseline visit.
- Subject with plaque psoriasis at screening that is severe enough to be candidate for systemic therapy.
- Subject is 18 to 80 years of age .
- Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
Key exclusion criteria (20 listed)
- Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis or with subject's safety.
- Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex (a component of the pre-filled syringe).
- Subject who has used topical treatments in the last 4 weeks of the etanercept treatment period when the response to etanercept was evaluated as unsatisfactory must use the same topical therapy with the same agents applied in the same manner and with the same application frequency for two weeks prior to the baseline visit as well as during the entire trial. The use of any other topical treatment for psoriasis is prohibited except for allowed treatments.
- Subject who has used UVB phototherapy, excessive sun exposure, phototherapy or any non-biological systemic therapy for the treatment of psoriasis less than 30 days before day 0. Investigational chemical agents must be discontinued at least 30 days or 5 half-lives prior to the Baseline visit (whichever is longer).
- Subject who has used any biological therapy (apart from etanercept) for the treatment of psoriasis less than 3 months (90 days) before day 0. Etanercept must be discontinued before baseline but a washout period is not required.
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 |
|---|---|---|
| Adalimumab every other weekAlso: HUMIRAAdalimumab 40mg injection every other week for 24 weeks | Drug | Group A, Group B |
| Adalimumab Every WeekAlso: HUMIRAAdalimumab 40mg injection every week for the last 12 weeks of study. | Drug | Group A dose increase at Week 12, Group B dose increase at Week 12 |
Primary outcome
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Time frame: 12 weeks
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
4 secondary outcomes
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Time frame: 12 weeks
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
Time frame: 24 weeks
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
Time frame: 24 weeks
Total Number of Adverse Events for All Patients in the Study.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- 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.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab every other week and Adalimumab Every Week in people with Plaque Psoriasis, run by Innovaderm Research Inc. at 12 sites in Canada.
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 15 inclusion and 20 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aug 2010). 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?
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12. (time frame: 12 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 9 Sep 2011.