Phase 3
N=363
The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01139580 ↗Enrolled (actual)
363
Serious AEs
1.1%
Results posted
Sep 2011
Primary outcome: Primary: 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 — 74; 44 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Calcipotriene Foam (Drug); Vehicle Foam (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Stiefel, a GSK Company
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
74; 44 | <0.001 sig |
| PRIMARY 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) |
75; 45 | 0.001 sig |
| SECONDARY 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 |
42; 30 | — |
| SECONDARY 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 |
53; 38 | — |
| SECONDARY Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 |
67; 53 | — |
| SECONDARY Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 |
32; 28; 33; 28 | — |
Summary
The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01139580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.