Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: halobetasol (Drug); clobetasol (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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.
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).
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: assess the improvement of symptoms of psoriasis
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
Minimum age: 18 Years.
Maximum age: N/A.
- Patients of both sexes, adults over 18 years, holders of psoriasis plating of mild to
- 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
- 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
- Patients who have made systemic treatment for psoriasis in the 4 months preceding the
- Patients who do not agree with the conditions described in the Statement of Informed
- 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
Locations and Contacts
Lal Clinica, Valinhos, Sao Paulo 13270000, Brazil
Starting date: July 2008
Last updated: July 14, 2008