Halobetasol Propionate OintmentHormone imbalance Halobetasol can be absorbed into halobetasol propionate lotion body through your skin. This may affect how your body produces hormones. Wash your hands well after applying this medication. Halobetasol is a halobetasol propionate lotion drug. Halobetasol is available as a generic drug.
Halobetasol Propionate Ointment - FDA prescribing information, side effects and uses
Double Participant, Investigator Primary Purpose: November Actual Primary Completion Date: February Actual Study Completion Date: Psoriasis Drug Information available for: Halobetasol Propionate Lotion 0. Vehicle Lotion Topical lotion, applied twice daily Drug: The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment Day Success was defined as a grade of 0 or 1 on the ODS scale.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Ages Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria:. Hide glossary Glossary Study record managers: Search for terms x. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Read our disclaimer for details. This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.
Eligible subjects will be randomized 1: The maximum amount of test article to be applied per week should not exceed 50 grams. Drug Information available for: Apply twice daily for weeks, not to exceed 50 grams per week. The proportion of subjects rated a "treatment success" for each of the clinical signs and symptoms of psoriasis: Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Subject is Male or non-pregnant female; 18 years of age at time of Screening. Subject is willing and able to give written informed consent. If subject is a woman of childbearing potential WOCBP , she must have a negative urine pregnancy test UPT and agree to use an effective form of birth control for the duration of the study i. Abstinence is an acceptable form of birth control for subjects who are not sexually active.
Subjects who become sexually active during the trial must agree to use an effective form of birth control for the duration of the study. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
Subject has used any phototherapy including laser , photo-chemotherapy or systemic corticosteroid therapy such as systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids] within 30 days prior to the Baseline Visit.
Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to the Baseline Visit.
Subject has used any systemic biologic therapy i. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value. Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study that is thought by the investigator likely to modify the subject's disease.
Subject has used topical body excluding the scalp psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs e. Subject is currently using lithium or Plaquenil hydroxychloroquine. Subject is currently using a beta-blocking medication e. Subject has a history of sensitivity to any of the ingredients in the test article.
Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject is currently enrolled in an investigational drug or device study. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit. Subject has been previously enrolled in this study and treated with a test article.
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol e. 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. Austin, Texas, United States, April 11, Last Update Posted: May 13, Last Verified: April Keywords provided by Therapeutics, Inc.: National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. June 4, Results First Posted: Actual Primary Completion Date:. Actual Study Completion Date:. Vehicle Lotion Topical lotion, applied twice daily. San Diego, California, United States, Minnesota Clinical Study Center. Fridley, Minnesota, United States,