NCT00715975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 2, 2010

Status Verified

August 1, 2010

Enrollment Period

1.8 years

First QC Date

July 11, 2008

Last Update Submit

August 31, 2010

Conditions

Psoriasis

Keywords

clobetasolhalobetasolpsoriasisevaluating the efficacy and tolerability of the drug Halobetasol propionate

Outcome Measures

Primary Outcomes (1)

  • assess the improvement of symptoms of psoriasis

    complete improvement

Study Arms (2)

1

EXPERIMENTAL

The patients will be treated with halobetasol once a day for 15 days.

Drug: halobetasol

2

EXPERIMENTAL

The patients will be treated with clobetasol once a day for 15 days.

Drug: clobetasol

Interventions

halobetasolDRUG

The patients will be treated with halobetasol once a day for 15 days.

1
clobetasolDRUG

The patients will be treated with clobetasol once a day for 15 days.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lal Clinica

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Psoriasis

Interventions

halobetasolClobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

September 2, 2010

Record last verified: 2010-08

Locations

BR(1)