Completed
An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
What is being tested
122-0551
Drug
Who is being recruted
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: April 2012
Summary
Principal SponsorTherapeutics, Inc.
Last updated: October 24, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2012
Actual date on which the first participant was enrolled.Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.
Principal SponsorTherapeutics, Inc.
Last updated: October 24, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
1 inclusion criteria required to participate
Subject has a clinical diagnosis of stable plaque psoriasis
14 exclusion criteria prevent from participating
Subject has an irregular sleep schedule or works night shifts
Subject has been previously enrolled in this study and treated with the test article
Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Therapeutics Clinical Research
San Diego, United StatesDermResearch, Inc.
Austin, United StatesCompleted3 Study Centers