A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118 - Full Text View

Purpose

Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: IDP-118 Low Strength Drug: IDP-118 High Strength	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:

The incidence of HPA axis suppression after treatment with investigational drug product and the comparators [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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.

Other Outcome Measures:

To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	60
Study Start Date:	June 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IDP-118 Low Strength IDP-118 Low Strength	Drug: IDP-118 Low Strength 8 weeks Other Name: IDP-118
Experimental: IDP-118 High Strength IDP-118 High Strength	Drug: IDP-118 High Strength 8 weeks Other Name: IDP-118

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670513

Locations

United States, California
Dow Clinical Study Site
Santa Rosa, California, United States, 95403
United States, Michigan
Dow Clinical Study Site
Clinton Township, Michigan, United States, 48038
Dow Cliincal Study Site
Fort Gratiot, Michigan, United States, 48059
United States, Tennessee
Dow Clinical Study Site
Nashville, Tennessee, United States, 37215
United States, Texas
Dow Clinical Study Site
Austin, Texas, United States, 78759
United States, Virginia
Dow Clinical Study Site
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Dow Pharmaceutical Sciences

Investigators

Study Director:

Todd Plott, MD

Medical Monitor

More Information

No publications provided

Responsible Party:	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT01670513 History of Changes
Other Study ID Numbers:	DPSI-IDP-118-P2-01
Study First Received:	May 31, 2012
Last Updated:	April 23, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dow Pharmaceutical Sciences:

Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013