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Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis (halobetasol)

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ClinicalTrials.gov Identifier: NCT00715975
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:
Azidus Brasil

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: halobetasol Drug: clobetasol Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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).
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. assess the improvement of symptoms of psoriasis [ Time Frame: complete improvement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715975


Locations
Brazil
Lal Clinica
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00715975     History of Changes
Other Study ID Numbers: HALGLE0508
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: August 2010

Keywords provided by Azidus Brasil:
clobetasol
halobetasol
psoriasis
evaluating the efficacy and tolerability of the drug Halobetasol propionate

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Halobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Vasoconstrictor Agents