Back to resultsA Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118 (IDP-118)
Primary Purpose
Plaque Psoriasis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDP-118 Low Strength
IDP-118 High Strength
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Dow Clinical Study Site
- Dow Clinical Study Site
- Dow Cliincal Study Site
- Dow Clinical Study Site
- Dow Clinical Study Site
- Dow Clinical Study Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IDP-118 Low Strength
IDP-118 High Strength
Arm Description
IDP-118 Low Strength
IDP-118 High Strength
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis.
Full Information
NCT ID
NCT01670513
First Posted
May 31, 2012
Last Updated
April 23, 2013
Sponsor
Dow Pharmaceutical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01670513
Brief Title
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Acronym
IDP-118
Official Title
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow Pharmaceutical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IDP-118 Low Strength
Arm Type
Experimental
Arm Description
IDP-118 Low Strength
Arm Title
IDP-118 High Strength
Arm Type
Experimental
Arm Description
IDP-118 High Strength
Intervention Type
Drug
Intervention Name(s)
IDP-118 Low Strength
Other Intervention Name(s)
IDP-118
Intervention Description
8 weeks
Intervention Type
Drug
Intervention Name(s)
IDP-118 High Strength
Other Intervention Name(s)
IDP-118
Intervention Description
8 weeks
Primary Outcome Measure Information:
Title
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
Description
To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
Description
To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study
Description
The Investigator will assess the target lesion site affected by psoriasis at each visit. Areas affected by psoriasis (at a minimum 10% BSA) are to be treated with study drug
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Plott, MD
Organizational Affiliation
Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
Dow Clinical Study Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Dow Clinical Study Site
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Dow Cliincal Study Site
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Dow Clinical Study Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Dow Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Dow Clinical Study Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
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