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

Plaque Psoriasis Clinical Trial

— IDP-118  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01670513
• Other study ID #: DPSI-IDP-118-P2-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 31, 2012
• Last updated: April 23, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Dow Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• IDP-118 Low Strength
8 weeks
• IDP-118 High Strength
8 weeks

Locations

Country	Name	City	State
United States	Dow Clinical Study Site	Austin	Texas
United States	Dow Clinical Study Site	Clinton Township	Michigan
United States	Dow Cliincal Study Site	Fort Gratiot	Michigan
United States	Dow Clinical Study Site	Nashville	Tennessee
United States	Dow Clinical Study Site	Norfolk	Virginia
United States	Dow Clinical Study Site	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	Yes