We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Dow Pharmaceutical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670513
First Posted: August 22, 2012
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01670513     History of Changes
Other Study ID Numbers: DPSI-IDP-118-P2-01
First Submitted: May 31, 2012
First Posted: August 22, 2012
Last Update Posted: April 25, 2013
Last Verified: April 2013

Keywords provided by Dow Pharmaceutical Sciences:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases