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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

May 31, 2012
April 23, 2013
June 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01670513 on ClinicalTrials.gov Archive Site
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.
Same as current
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
Same as current
 
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: IDP-118 Low Strength
    8 weeks
    Other Name: IDP-118
  • Drug: IDP-118 High Strength
    8 weeks
    Other Name: IDP-118
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670513
DPSI-IDP-118-P2-01
No
Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences
Not Provided
Study Director: Todd Plott, MD Medical Monitor
Dow Pharmaceutical Sciences
April 2013

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