The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
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|ClinicalTrials.gov Identifier: NCT03848871|
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Enstilar||Phase 4|
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.
Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients|
|Actual Study Start Date :||December 12, 2017|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||December 10, 2018|
Experimental: Enstilar foam
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar foam applied to affected area once daily
Other Name: calcipotriene and betamethasone dipropionate
- Change in Physicians Global Assessment (PGA) from Baseline to week 2 and week 4 [ Time Frame: screening/baseline, week 2, week 4 ]Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
- Change in Lesion size from baseline to week 2 and week 4 [ Time Frame: screening/baseline, week 2, week 4 ]Size of target lesion recorded as height in cm x length in cm
- Change in Body Surface Area (BSA) from Baseline to week 2 and week 4 [ Time Frame: screening/baseline, week 2, week 4 ]Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%)
- Change in TLSS (Total Lesion Severity Score) from baseline to week 2 and week 4 [ Time Frame: screening/baseline, week 2, week 4 ]A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848871
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|