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

NCT01610596 | Completed Phase 2 Results

• 1 other identifier: 000-0551-207
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Psoriasis; Plaque Psoriasis

Keywords

Psoriasis; Skin Diseases; Halobetasol; Vasoconstrictor Agents; Therapeutic Uses; Pharmacologic Actions; Anti-Inflammatory Agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• Overall Disease Severity Score (Success)

  Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.

  Day 15

Secondary Outcomes (3)

• Percent Body Surface Area

  Baseline, Days 8 and 15

• Clinical Signs and Symptoms of Psoriasis

  Days 8 and 15

• Overall Disease Severity Score (Improvement)

  Days 8 and 15

Study Arms (2)

Halobetasol Propionate Lotion 0.05%

EXPERIMENTAL

Topical lotion, applied twice daily

Drug: Halobetasol Propionate Lotion 0.05%

Vehicle Lotion

PLACEBO COMPARATOR

Topical lotion, applied twice daily

Drug: Placebo

Interventions

Halobetasol Propionate Lotion 0.05% DRUG

Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Halobetasol Propionate Lotion 0.05%

Placebo DRUG

Vehicle Lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• Subject has an Overall Disease Severity (ODS) score for the Treatment Area of at least three (3) at the Baseline Visit.
• 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.

You may not qualify if:

• 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.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.
• 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.g., Dovonex®) within 14 days prior to the Baseline Visit.
• Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
• Subject is currently using lithium or Plaquenil (hydroxychloroquine).
• 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.
• 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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (3)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research, Therapeutics Inc.
• Organization: Therapeutics, Inc.

clinicalresearch@therapeuticsinc.com

858-571-1800

Study Officials

• Syd Dromgoole, PhD

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: June 4, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 13, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-04

Locations

US (3)