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| Sponsor: | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
|---|---|
| Information provided by: | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| ClinicalTrials.gov Identifier: | NCT00715975 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: halobetasol Drug: clobetasol |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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). |
| Estimated Enrollment: | 140 |
| Study Start Date: | July 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
The patients will be treated with halobetasol once a day for 15 days.
|
Drug: halobetasol
The patients will be treated with halobetasol once a day for 15 days.
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|
Experimental: 2
The patients will be treated with clobetasol once a day for 15 days.
|
Drug: clobetasol
The patients will be treated with clobetasol once a day for 15 days.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Alexandre Frederico, LAL Clinica |
| ClinicalTrials.gov Identifier: | NCT00715975 History of Changes |
| Other Study ID Numbers: | HALGLE0508 |
| Study First Received: | July 11, 2008 |
| Last Updated: | August 31, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
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clobetasol halobetasol psoriasis evaluating the efficacy and tolerability of the drug Halobetasol propionate |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Clobetasol Halobetasol Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents |
