A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
IDP-118
1 other identifier
interventional
60
1 country
6
Brief Summary
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 25, 2013
April 1, 2013
11 months
May 31, 2012
April 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
8 weeks
Secondary Outcomes (1)
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
8 weeks
Other Outcomes (1)
To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study
8 weeks
Study Arms (2)
IDP-118 Low Strength
EXPERIMENTALIDP-118 Low Strength
IDP-118 High Strength
EXPERIMENTALIDP-118 High Strength
Interventions
Eligibility Criteria
You may qualify if:
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Freely given verbal and written informed consent obtained from the subject.
- Clinical diagnosis of psoriasis at the Screening and Baseline visits with
- At least 10% - 20% of total treatable BSA involvement, and
- an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
- Good general health as determined by the Investigator based on the subject's medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits.
You may not qualify if:
- Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
- History of adrenal disease
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Dow Clinical Study Site
Santa Rosa, California, 95403, United States
Dow Clinical Study Site
Clinton Township, Michigan, 48038, United States
Dow Cliincal Study Site
Fort Gratiot, Michigan, 48059, United States
Dow Clinical Study Site
Nashville, Tennessee, 37215, United States
Dow Clinical Study Site
Austin, Texas, 78759, United States
Dow Clinical Study Site
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Todd Plott, MD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2012
First Posted
August 22, 2012
Study Start
June 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
April 25, 2013
Record last verified: 2013-04