Psoriasis
Conditions
Keywords
Plaque Psoriasis, Psoriasis
Brief 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.
Detailed 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.
Interventions
DRUGCalcipotriene 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
DRUGVehicle Foam
Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 8 | 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. |
| 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) | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 | Baseline and 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. |
| Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcipotriene Foam Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks. | 181 |
| Vehicle Foam Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks. | 182 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Beginning Study Exclusion Treatment | 0 | 1 |
| Overall Study | Did Not Meet Exclusion Criteria | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 9 | 1 |
| Overall Study | Misrandomized | 1 | 0 |
| Overall Study | Participant Randomization in Error | 0 | 1 |
| Overall Study | Used Excluded Medicine After Enrollment | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | Calcipotriene Foam | Vehicle Foam | Total |
|---|---|---|---|
| Age, Continuous | 45.9 Years STANDARD_DEVIATION 15.3 | 44.4 Years STANDARD_DEVIATION 15.5 | 45.2 Years STANDARD_DEVIATION 15.4 |
| Gender Female | 69 Participants | 76 Participants | 145 Participants |
| Gender Male | 112 Participants | 106 Participants | 218 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 6 participants | 3 participants | 9 participants |
| Race/Ethnicity, Customized Black | 15 participants | 18 participants | 33 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Multiracial | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 156 participants | 160 participants | 316 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 181 | 17 / 182 |
| serious Total, serious adverse events | 1 / 181 | 3 / 182 |
Outcome results
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.
Time frame: Week 8
Population: Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | 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 participants |
| Vehicle Foam | 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 | 44 participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | 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 participants |
| Vehicle Foam | 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) | 45 participants |
p-value: 0.001Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: ITT Population. Data were analyzed using the failure and LOCF methods.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcipotriene Foam | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | Failure method | 32 participants |
| Calcipotriene Foam | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | LOCF | 33 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | Failure method | 28 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | LOCF | 28 participants |
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.
Time frame: Baseline and Week 8
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | 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 participants |
| Vehicle Foam | 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 | 30 participants |
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.
Time frame: Baseline and Week 8
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 | 67 participants |
| Vehicle Foam | Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 | 53 participants |
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.
Time frame: Baseline and Week 8
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | 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 participants |
| Vehicle Foam | 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 | 38 participants |