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|
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|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.
- 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.
- 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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