Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01610596
First received: January 18, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.


Condition Intervention Phase
Psoriasis
Plaque Psoriasis
Drug: Halobetasol Propionate Lotion 0.05%
Drug: Placebo
Phase 2

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: A Double-blind, Randomized, Multicenter, Vehicle-Controlled Parallel Group Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Resource links provided by NLM:


Further study details as provided by Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall Disease Severity Score [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the proportion of subjects with ODS "treatment success" at end of treatment.


Secondary Outcome Measures:
  • Percent Body Surface Area [ Time Frame: Days 8 and 15 ] [ Designated as safety issue: No ]
    Changes in percent BSA with active psoriasis in the Treatment Area

  • Clinical signs and symptoms of psoriasis [ Time Frame: Days 8 and 15 ] [ Designated as safety issue: No ]
    The proportion of subjects rated a "treatment success" for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque evaluation and pruritis. "Treatment success" is defined as a score of 0 or 1.

  • Overall Disease Severity Score [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    The proportion of subjects rated a "treatment success" for ODS. "Treatment success" is defined as a score of 0 or 1


Enrollment: 72
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Halobetasol Propionate Lotion 0.05%
Topical lotion, applied twice daily
Drug: Halobetasol Propionate Lotion 0.05%
Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
Placebo Comparator: Vehicle Lotion
Topical lotion, applied twice daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is Male or non-pregnant female; 18 years of age at time of Screening.
  2. Subject is willing and able to give written informed consent.
  3. subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
  4. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than approximately 10% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
  5. Subject has an Overall Disease Severity (ODS) score for the Treatment Area of at least three (3) at the Baseline Visit.
  6. 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.e., abstinence, stabilized on hormonal contraceptives [oral, injectable, transdermal or intravaginal] or IUD for at least three months prior to test article application, condom and a spermicidal, or diaphragm and a spermicidal). 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.

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
  3. 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.
  4. 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.
  5. Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to the Baseline Visit.
  6. Subject has used any systemic biologic therapy (i.e., FDA approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value.
  7. 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.
  8. Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the Baseline Visit.
  9. Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
  10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
  11. Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
  12. Subject has a history of sensitivity to any of the ingredients in the test article.
  13. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  14. Subject is currently enrolled in an investigational drug or device study.
  15. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
  16. Subject has been previously enrolled in this study and treated with a test article.
  17. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. 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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610596

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01610596     History of Changes
Other Study ID Numbers: 000-0551-207
Study First Received: January 18, 2012
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Therapeutics, Inc.:
Psoriasis
Skin Diseases
Halobetasol
Vasoconstrictor Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Physiological Effects of Drugs

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

ClinicalTrials.gov processed this record on November 24, 2014