Last updated: 11/07/2018 08:15:31
The purpose of this study is to demonstrate the safety and effectiveness of calcipotriene foam in subjects with scalp and body psoriasis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis
Trial description: The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: 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)
Timeframe: Week 8
Secondary outcomes:
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
Timeframe: 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
Timeframe: Baseline and Week 8
Number of participants with a target lesion score of 0 or 1 for plaque thickness at Week 8
Timeframe: Baseline and Week 8
Number of participants with an ISGA score of clear (0) or almost clear (1) for body involvement at Week 8
Timeframe: Week 8
Interventions:
Drug: Calcipotriene Foam
Drug: Vehicle Foam
Enrollment:
363
Observational study model:
Not applicable
Primary completion date:
2010-22-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
calcipotriol
Collaborators
GSK
Study date(s)
May 2010 to December 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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.
- Any subject who has participated in any previous calcipotriene foam clinical.
- Female who is pregnant, trying to become pregnant, or breastfeeding.
Inclusion and exclusion 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.
- 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.
- 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.
Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:
Negative urine pregnancy test for females of childbearing potential.
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.
Trial location(s)
Location
Central Dermatology PC
St. Louis, MO, United States, 63117
Status
Recruitment Complete
Location
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, NC, United States, 27157
Status
Recruitment Complete
Location
Dermatology Specialists
Louisville, KY, United States, 40202
Status
Recruitment Complete
Location
Tennessee Clinical Research
Nashville, TN, United States, 37215
Status
Recruitment Complete
Location
Cherry Creek Research, Inc.
Denver, CO, United States, 80209
Status
Recruitment Complete
Location
Dermatology Associates of Rochester, PC
Rochester, NY, United States, 14623
Status
Recruitment Complete
Location
Miami Dermatology Research Institute LLC
North Miami Beach, FL, United States, 33169
Status
Recruitment Complete
Location
Group Health Associates
Cincinnatti, OH, United States, 45220
Status
Recruitment Complete
Location
The Skin Wellness Center, PC
Knoxville, TN, United States, 37922
Status
Recruitment Complete
Location
Dermatology Clinical Research Center of San Antonio
San Antonio, TX, United States, 78229
Status
Recruitment Complete
Location
Genova Clinical Research
Tucson, AZ, United States, 85791
Status
Recruitment Complete
Location
Coastal Carolina Research Center
Mt. Pleasant, SC, United States, 29464
Status
Recruitment Complete
Location
Dermatology Consulting Services
High Point, NC, United States, 27262
Status
Recruitment Complete
Location
Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery
New York, NY, United States, 10029
Status
Recruitment Complete
Location
Gwinnett Clinical Research Center, Inc.
Snellville, GA, United States, 30078
Status
Recruitment Complete
Location
Henry Ford Medical Center
Detroit, MI, United States, 48202
Status
Recruitment Complete
Location
Suzanne Bruce and Associates, PA
Houston, TX, United States, 77056
Status
Recruitment Complete
Location
Education and Research Foundation
Lynchburg, VA, United States, 24501
Status
Recruitment Complete
Location
Minnesota Clinical Study Center
Fridley, MN, United States, 55432
Status
Recruitment Complete
Location
Dermatology Research Center, Inc.
Salt Lake City, UT, United States, 84124
Status
Recruitment Complete
Location
Therapeutics Clinical Research Center, Inc.
San Diego, CA, United States, 92123
Status
Recruitment Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-22-12
Actual study completion date
2010-22-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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