A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118 (IDP-118)

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

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: IDP-118 Low Strength; Drug: IDP-118 High Strength

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-118 Low Strength	Drug: IDP-118 Low Strength; 8 weeks; Other Names: IDP-118
Experimental: IDP-118 High Strength	Drug: IDP-118 High Strength; 8 weeks; Other Names: IDP-118

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study	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	8 weeks

Collaborators and Investigators

• Sponsor: Dow Pharmaceutical Sciences
• Investigators: Study Director: Todd Plott, MD, Medical Monitor

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): April 25, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DPSI-IDP-118-P2-01