The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

Stiefel

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Drug: Vehicle Foam

Drug: Calcipotriene Foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01139580

114743

U0267-303 (Other Identifier)

Details and patient eligibility

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

363 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy 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:
- Plaque-type psoriasis involving 3% to 10% of total body surface area (BSA).
- An Investigator's Static Global Assessment (ISGA) score of 3 at Baseline.
- Identification of a target lesion (>2 cm²) on the trunk or extremities with a score of 2 or 3 (0-5 scale) for erythema, scaling and plaque thickness. Lesions on the palms/soles, knees, elbow, and intertriginous areas should not be used as the target lesion site.
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

Any subject who has participated in any previous calcipotriene foam clinical.
Female who is pregnant, trying to become pregnant, or breastfeeding.
Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations.
History of hypercalcemia or of vitamin D toxicity.
Other serious skin disorder or any chronic medical condition that is not well-controlled.
Use of nonbiologic systemic anti-psoriatic therapy (eg, corticosteroids, psoralen combined with exposure to ultraviolet light A [PUVA], ultraviolet light B [UVB], retinoids, methotrexate, cyclosporine, other immunosuppressive agents) within 4 weeks prior to enrollment.
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental products prior to randomization.
Use of topical therapies that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, Vitamin D derivatives, coal tar, or anthralin, within 2 weeks prior to enrollment.
Systemic medications for other medical conditions that are known to affect psoriasis (eg, lithium, beta adrenergic blockers) within 4 weeks prior to enrollment.
Use of any investigational product within 4 weeks prior to enrollment, currently participating in another clinical trial, or plans to receive an investigational product during the study.
Current drug or alcohol abuse (drug screening not required).
Has a history of any immuno-compromizing disease.
Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Employees of the investigator; study center; or Stiefel, a GSK company involved in the study; or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.