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

Phase 1

• Conditions: Plaque Psoriasis
• Interventions: Drug: IDP-118 Low Strength; Drug: IDP-118 High Strength

• Registration Number: NCT01670513
• Lead Sponsor: Dow Pharmaceutical Sciences

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.

Study Timeline

• Study First Submitted: 2012-05-31
• Study Start: 2012-06
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-25
• Primary Completion: 2013-05
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-118 Low Strength	IDP-118 Low Strength	IDP-118 Low Strength
IDP-118 High Strength	IDP-118 High Strength	IDP-118 High Strength

Primary Outcome Measures

Name	Time	Method
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators	8 weeks	To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators	8 weeks	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.

Trial Locations

Locations (2)

Dow Cliincal Study Site; 🇺🇸 Fort Gratiot, Michigan, United States

Dow Clinical Study Site; 🇺🇸 Norfolk, Virginia, United States