PsoriasisPhase 2/3halobetasolNCT00715975
Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis
A Phase 2/3 study testing halobetasol and clobetasol in people with Psoriasis, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. 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 and clobetasol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Aug 2010
- Phase
- Phase 2/3
- 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
- Patients of both sexes, adults over 18 years, holders of psoriasis plating of mild to moderate,
- Patients with area of involvement of up to 20% of body surface,
- Patients with good physical and mental health
- Patients who agree with the purposes of the study and sign the Informed Consent
Who cannot join
- Patients with skin diseases other than psoriasis or which alter the clinical evaluation and development of disease,
- Patients with psoriasis in more than 20% of the body,
- Patients with other types of psoriasis that are not "plating",
- patient with a scalp psoriasis who have difficulty in application of the product,
- Patients who have made topical treatment for psoriasis in the 2 months preceding the study,
- Patients who have made systemic treatment for psoriasis in the 4 months preceding the study,
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- Patients who do not agree with the conditions described in the Statement of Informed Consent
- Patients who are pregnant and breastfeeding,
- Patients in use of oral anticoagulants,
- Patients who have psoriatics addition to plaques of skin disorders caused by fungi or bacteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis Plate, and as Comparator the Product Psorex (Clobetasol Propionate).
The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age for the onset of the disease and around 27.3 years.
The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar to the Clobetasol corticoid this, until then classified as the most potent corticoid used worldwide in clinical practice. However, the molecular structure of Halobetasol gives it increased its activity antiinflammatory and anti-proliferative.
The objective of this study is evaluating the efficacy and tolerability of the drug Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
Read the detailed description
The patients eligible will be informed about the procedures of the study and that agree to participate and sign the TCLE will be initially evaluated clinically for the clinical diagnosis of psoriasis plate with mild and moderate involvement of up to 20% of body surface. After the procedures for selection (initial clinical evaluation and verification of the criteria for inclusion and exclusion) the patients will be photographed, receive treatment and will be targeted and to manage it in proper way and standardized, when they do so at home. In each return (after 7, 14 days) will be held photographs of injuries, clinical examination, evaluation of adverse events and dispensing of medicine to patients.
The drugs dispensed will be sufficient for daily use until the next return. The product will be applied once a day, during night, preferably after the bath. The follow-up visits will occur in times of 07 and 14 days after the start of treatment. If there is complete improves the disease, treatment is interrupted before this date. On each visit will be examined by clinical parameters validated scales of assessment internationally (PASI), which provide the exact data of changes in the framework of each patient in each parameter measured. As parameters of the tolerability will be evaluated frequency and intensity of adverse events and the potential of irritative formulations, will be held photo of patients and questionnaires of cosmeticidade the formulation. Patients will be geared not to expose to the sun during the treatment period. At the end of the study, patients who present evolution will be full of injuries released the study and those who are still with obvious symptoms have treatment interrupted because of the risk of prolonged use of the drug under study. These patients will be referred to the Health Service for maintenance treatment with a new therapy. The patients who are released and make recurrence of the disease due to the rebound effect will be
- Conditions
- Psoriasis
- Being tested
- halobetasol, clobetasol
- Keywords
- clobetasol, halobetasol, psoriasis, evaluating the efficacy and tolerability of the drug Halobetasol propionate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
halobetasolDrug
The patients will be treated with halobetasol once a day for 15 days.
clobetasolDrug
The patients will be treated with clobetasol once a day for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The patients will be treated with halobetasol once a day for 15 days. Receives: Drug: halobetasol |
| 2 | Experimental | The patients will be treated with clobetasol once a day for 15 days. Receives: Drug: clobetasol |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the improvement of symptoms of psoriasis
Measured: complete improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionAug 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715975
- Sponsor's protocol ID
- HALGLE0508
- Acronym
- halobetasol
- Status last verified
- Aug 2010
- First submitted
- 11 Jul 2008
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis Plate, and as Comparator the Product Psorex (Clobetasol Propionate).
- ClinicalTrials.gov ID
- NCT00715975
- Acronym / sponsor ID
- halobetasol / HALGLE0508
- Conditions
- Psoriasis
- Keywords
- clobetasol, halobetasol, psoriasis, evaluating the efficacy and tolerability of the drug Halobetasol propionate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Jul 2008 (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 Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age for the onset of the disease and around 27.3 years.
The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar to the Clobetasol corticoid this, until then classified as the most potent corticoid used worldwide in clinical practice. However, the molecular structure of Halobetasol gives it increased its activity antiinflammatory and anti-proliferative.
The objective of this study is evaluating the efficacy and tolerability of the drug Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
Detailed description
The patients eligible will be informed about the procedures of the study and that agree to participate and sign the TCLE will be initially evaluated clinically for the clinical diagnosis of psoriasis plate with mild and moderate involvement of up to 20% of body surface. After the procedures for selection (initial clinical evaluation and verification of the criteria for inclusion and exclusion) the patients will be photographed, receive treatment and will be targeted and to manage it in proper way and standardized, when they do so at home. In each return (after 7, 14 days) will be held photographs of injuries, clinical examination, evaluation of adverse events and dispensing of medicine to patients.
The drugs dispensed will be sufficient for daily use until the next return. The product will be applied once a day, during night, preferably after the bath. The follow-up visits will occur in times of 07 and 14 days after the start of treatment. If there is complete improves the disease, treatment is interrupted before this date. On each visit will be examined by clinical parameters validated scales of assessment internationally (PASI), which provide the exact data of changes in the framework of each patient in each parameter measured. As parameters of the tolerability will be evaluated frequency and intensity of adverse events and the potential of irritative formulations, will be held photo of patients and questionnaires of cosmeticidade the formulation. Patients will be geared not to expose to the sun during the treatment period. At the end of the study, patients who present evolution will be full of injuries released the study and those who are still with obvious symptoms have treatment interrupted because of the risk of prolonged use of the drug under study. These patients will be referred to the Health Service for maintenance treatment with a new therapy. The patients who are released and make recurrence of the disease due to the rebound effect will be
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: halobetasolThe patients will be treated with halobetasol once a day for 15 days. |
| 2 | Experimental | Drug: clobetasolThe patients will be treated with clobetasol once a day for 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes, adults over 18 years, holders of psoriasis plating of mild to moderate,
- Patients with area of involvement of up to 20% of body surface,
- Patients with good physical and mental health
- Patients who agree with the purposes of the study and sign the Informed Consent
Key exclusion criteria (10 listed)
- Patients with skin diseases other than psoriasis or which alter the clinical evaluation and development of disease,
- Patients with psoriasis in more than 20% of the body,
- Patients with other types of psoriasis that are not "plating",
- patient with a scalp psoriasis who have difficulty in application of the product,
- Patients who have made topical treatment for psoriasis in the 2 months preceding the study,
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 |
|---|---|---|
| halobetasolThe patients will be treated with halobetasol once a day for 15 days. | Drug | 1 |
| clobetasolThe patients will be treated with clobetasol once a day for 15 days. | Drug | 2 |
Primary outcome
assess the improvement of symptoms of psoriasis
Time frame: complete improvement
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 2 Sep 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing halobetasol and clobetasol in people with Psoriasis, run by Azidus Brasil at 1 site in Brazil.
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 4 inclusion and 10 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 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 combined 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.
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?
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?
assess the improvement of symptoms of psoriasis (time frame: complete improvement). 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 2 Sep 2010.