Plaque Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
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.
Interventions
DRUGIDP-118 Low Strength
8 weeks
DRUGIDP-118 High Strength
8 weeks
Sponsors
Dow Pharmaceutical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of HPA axis suppression after treatment with investigational drug product and the comparators | 8 weeks | To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and cutaneous tolerability of the two formulations and the comparators | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study | 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 |
Countries
United States
Outcome results
None listed