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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 11, 2008 |
| Last Updated Date | July 14, 2008 |
| Start Date ICMJE | July 2008 |
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
assess the improvement of symptoms of psoriasis [ Time Frame: complete improvement ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00715975 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis |
| Official Title ICMJE | 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). |
| Brief 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. 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 Phase | Phase II, Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Psoriasis |
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Not yet recruiting |
| Estimated Enrollment ICMJE | 140 |
| Completion Date | |
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | Brazil |
| Administrative Information | |
| NCT ID ICMJE | NCT00715975 |
| Responsible Party | Alexandre Frederico, LAL Clinica |
| Study ID Numbers ICMJE | HALGLE0508 |
| Study Sponsor ICMJE | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| Verification Date | July 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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