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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139580
• Other study ID #: 114743
• Secondary ID: U0267-303
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2010
• Last updated: February 23, 2012
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Calcipotriene Foam
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
Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Locations

Country	Name	City	State
United States	DermReserach, Inc.	Austin	Texas
United States	Group Health Associates	Cincinnatti	Ohio
United States	Cherry Creek Research, Inc.	Denver	Colorado
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	The Skin Wellness Center, PC	Knoxville	Tennessee
United States	Dermatology Specialists	Louisville	Kentucky
United States	DermResearch, PLLC	Louisville	Kentucky
United States	Education and Research Foundation	Lynchburg	Virginia
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Tennessee Clinical Research	Nashville	Tennessee
United States	Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Miami Dermatology Research Institute LLC	North Miami Beach	Florida
United States	Oregon Medical	Portland	Oregon
United States	Dermatology Associates of Rochester, PC	Rochester	New York
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Therapeutics Clinical Research Center, Inc.	San Diego	California
United States	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia
United States	Central Dermatology PC	St. Louis	Missouri
United States	Genova Clinical Research	Tucson	Arizona
United States	Grekin Skin Institute	Warren	Michigan
United States	Wake Forest University Health Sciences Department of Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Week 8	No
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)	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.	Week 8	No
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	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.	Baseline and Week 8	No
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	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.	Baseline and Week 8	No
Secondary	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.	Baseline and Week 8	No
Secondary	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.	Week 8	No