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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Dow Pharmaceutical Sciences

ClinicalTrials.gov Identifier:

NCT01670513

First received: May 31, 2012

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 31, 2012

Last Updated Date

April 23, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01670513 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: IDP-118 Low Strength
8 weeks

Other Name: IDP-118
Drug: IDP-118 High Strength
8 weeks

Other Name: IDP-118

Study Arm (s)

Experimental: IDP-118 Low Strength
IDP-118 Low Strength

Intervention: Drug: IDP-118 Low Strength
Experimental: IDP-118 High Strength
IDP-118 High Strength

Intervention: Drug: IDP-118 High Strength

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01670513

Other Study ID Numbers ^ICMJE

DPSI-IDP-118-P2-01

Has Data Monitoring Committee

Responsible Party

Dow Pharmaceutical Sciences

Study Sponsor ^ICMJE

Dow Pharmaceutical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Todd Plott, MD

Medical Monitor

Information Provided By

Dow Pharmaceutical Sciences

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top