A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
This trial is active, not recruiting.
|Treatments||idp-118 low strength, idp-118 high strength|
|Phase||phase 1/phase 2|
|Sponsor||Dow Pharmaceutical Sciences|
|Start date||June 2012|
|End date||May 2013|
|Trial size||60 participants|
|Trial identifier||NCT01670513, DPSI-IDP-118-P2-01|
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Santa Rosa, CA||Dow Clinical Study Site||no longer recruiting|
|Clinton Township, MI||Dow Clinical Study Site||no longer recruiting|
|Fort Gratiot, MI||Dow Cliincal Study Site||no longer recruiting|
|Nashville, TN||Dow Clinical Study Site||no longer recruiting|
|Austin, TX||Dow Clinical Study Site||no longer recruiting|
|Norfolk, VA||Dow Clinical Study Site||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
IDP-118 Low Strength
IDP-118 High Strength
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
time frame: 8 weeks
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
time frame: 8 weeks
Male or female participants from 18 years up to 65 years old.
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.
|Official title||A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118|
|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.|
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