Plaque PsoriasisMEDNCT01279629
Open Clinical Study, Comparing Non-inferiority of Chronic Plaque Psoriasis
An observational study of Plaque Psoriasis, run by Glenmark Farmacêutica Ltda.
Trial summary
The purpose of this study is: To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis. Population: 50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to not given
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.
Who may be able to join
- Age range: Between 18 and 65
- A patient with chronic plaque psoriasis
- PASI <20%
- Presence of bilateral lesions with at least 2 cm in diameter and each with some degree of symmetry
- Levels of serum calcium and phosphorus within the normal range of reference or in case of changes, classified as irrelevant by the investigator
- In the case of female patients, agreement or maintenance of safe use of contraception such as barrier (condom, diaphragm), hormonal contraceptives (pills, implants or injections), IUDs, or abstinence (no sex)
- Reading, understanding, agreement and signature of the patient in the Term of Consent.
Who cannot join
- Gestation (confirmed by urine test indicator)
- Lactation
- History of hypersensitivity to components of medicines
- Psoriasis with different clinical presentation of the plates
- Clinical picture of psoriasis involving only the scalp, face, groin, armpit and / or other intertriginous area
- Patient requires the use of concomitant medication (topical or systemic) that may alter the course of the disease during the study period
Show all 15Show fewer
- Use of any systemic treatment for psoriasis within 12 weeks before the start of the study
- Use of systemic corticosteroids within 28 days before the start of the study
- Use of topical corticosteroids or other topical therapies in the areas of assessment within 02 weeks before the start of the study
- Use of phototherapy (UVB / UVA-P) within 04 weeks before the start of the study
- Patients who have participated in another clinical study within 30 days before the start of the study
- Use of any medication or possession of any disease which, in the opinion of the investigator might interfere with the performance or interpretation of the study
- Laboratory tests changed (serum AST and ALT, alkaline phosphatase, urea and creatinine, total bilirubin and fractions)
- Patients with demonstrated hypercalcemia or evidence of toxicity of vitamin D
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation
About this study
Official title: Open Clinical Study, Comparing Non-inferiority for Efficacy of the Drug Tazarotene 0.1% Versus the Comparator Drug Calcipotriol 0.005% in the Treatment of Chronic Plaque Psoriasis
The purpose of this study is:
To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.
- Population:
50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.
- Conditions
- Plaque Psoriasis
- Being tested
- Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).
- Keywords
- chronic plaque psoriasis, To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).Drug
Apply the medication once daily, preferably at night, in quantities sufficient to cover only the lesions with a thin layer of the product (an average of 2 mg/cm2).Apply only in lesions of the right hemisphere.
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene 0.1% | Not described Receives: Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). | |
| Calcipotriol 0.005% | Not described Receives: Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenmark Farmacêutica Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sergio Schalka, Principal investigator, Medcin Instituto da Pele Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279629
- Sponsor's protocol ID
- MED 865-10v3
- Acronym
- MED
- Status last verified
- Jan 2011
- First submitted
- 18 Jan 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Clinical Study, Comparing Non-inferiority for Efficacy of the Drug Tazarotene 0.1% Versus the Comparator Drug Calcipotriol 0.005% in the Treatment of Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01279629
- Acronym / sponsor ID
- MED / MED 865-10v3
- Conditions
- Plaque Psoriasis
- Keywords
- chronic plaque psoriasis, To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Glenmark Farmacêutica LtdaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- First posted
- 19 Jan 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.
The purpose of this study is:
To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.
- Population:
50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tazarotene 0.1% | – | Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). |
| Calcipotriol 0.005% | – | Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.
Key inclusion criteria (7 listed)
- Age range: Between 18 and 65
- A patient with chronic plaque psoriasis
- PASI <20%
- Presence of bilateral lesions with at least 2 cm in diameter and each with some degree of symmetry
- Levels of serum calcium and phosphorus within the normal range of reference or in case of changes, classified as irrelevant by the investigator
Key exclusion criteria (15 listed)
- Gestation (confirmed by urine test indicator)
- Lactation
- History of hypersensitivity to components of medicines
- Psoriasis with different clinical presentation of the plates
- Clinical picture of psoriasis involving only the scalp, face, groin, armpit and / or other intertriginous area
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 |
|---|---|---|
| Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).Apply the medication once daily, preferably at night, in quantities sufficient to cover only the lesions with a thin layer of the product (an average of 2 mg/cm2).Apply only in lesions of the right hemisphere. | Drug | Calcipotriol 0.005%, Tazarotene 0.1% |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
Sergio Schalka principal investigator
Medcin Instituto da Pele Ltda
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Glenmark Farmacêutica Ltda.
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 7 inclusion and 15 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: paused, as of the sponsor's last update on 20 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
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 20 Jun 2011.