The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.
The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
363
Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.
Time frame: Week 8
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.
Time frame: Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.
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Genova Clinical Research
Tucson, Arizona, United States
Therapeutics Clinical Research Center, Inc.
San Diego, California, United States
Cherry Creek Research, Inc.
Denver, Colorado, United States
Miami Dermatology Research Institute LLC
North Miami Beach, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Dermatology Specialists
Louisville, Kentucky, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
...and 16 more locations
Time frame: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.
Time frame: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.
Time frame: Baseline and Week 8
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8
The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.
Time frame: Week 8