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About
The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.
Full description
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Male or female subjects at least 12 years old and in good general health.
Able to complete the study and to comply with study instructions.
Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:
Involvement of at least 10% of the total scalp surface area with clinical signs (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.
Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are fewer than 2 years from their last menses.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
363 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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