Psoriasis
Conditions
Keywords
Plaque-type Psoriasis, Psoriasis
Brief summary
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Interventions
DRUGU0267
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
DRUGVehicle
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 12 years old and in good general health. * Mild to moderate plaque-type psoriasis
Exclusion criteria
* 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. * Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis. * Other serious skin disorder or any chronic medical condition that is not well controlled. * Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment. * Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment. * Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment. * Use of any investigational therapy within 4 weeks of enrollment. * Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | 8 weeks | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | 8 weeks | Erythema was assessed on a 6-point scale. 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 Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | 8 weeks | Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates. |
| Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | 8 weeks | Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more. |
| Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | 8 weeks | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. |
| Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | 8 weeks | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcipotriene Foam Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | 223 |
| Vehicle Foam Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | 113 |
| Total | 336 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Investigator decision | 1 | 0 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Prohibited medication | 1 | 0 |
| Overall Study | Subject moved out of area | 1 | 0 |
| Overall Study | Subject moved out of state | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Calcipotriene Foam | Vehicle Foam | Total |
|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 14.7 | 49.2 years STANDARD_DEVIATION 13.9 | 48.7 years STANDARD_DEVIATION 14.4 |
| Age, Customized 12 to <18 years | 4 participants | 1 participants | 5 participants |
| Age, Customized 18 to <65 years | 191 participants | 95 participants | 286 participants |
| Age, Customized > 65 years | 28 participants | 17 participants | 45 participants |
| Disease Characteristic - Erythema Bright red coloration | 0 participants | 1 participants | 1 participants |
| Disease Characteristic - Erythema Light red coloration | 74 participants | 37 participants | 111 participants |
| Disease Characteristic - Erythema Moderate red coloration | 149 participants | 75 participants | 224 participants |
| Disease Characteristic - Investigator's Static Global Assessment Mild | 73 participants | 34 participants | 107 participants |
| Disease Characteristic - Investigator's Static Global Assessment Moderate | 150 participants | 79 participants | 229 participants |
| Disease Characteristic - Percent BSA (extent of psoriasis) | 6.4 percent of body surface STANDARD_DEVIATION 4.8 | 5.8 percent of body surface STANDARD_DEVIATION 4.7 | 6.2 percent of body surface STANDARD_DEVIATION 4.8 |
| Disease Characteristic - Plaque Thickness Moderate elevation | 122 participants | 64 participants | 186 participants |
| Disease Characteristic - Plaque Thickness Slight but definite elevation | 101 participants | 49 participants | 150 participants |
| Disease Characteristic - Scaling Marked | 1 participants | 1 participants | 2 participants |
| Disease Characteristic - Scaling Mild | 91 participants | 51 participants | 142 participants |
| Disease Characteristic - Scaling Moderate | 131 participants | 61 participants | 192 participants |
| Disease Characteristic - Subject's Global Assessment Almost Clear | 0 participants | 1 participants | 1 participants |
| Disease Characteristic - Subject's Global Assessment Clear | 1 participants | 0 participants | 1 participants |
| Disease Characteristic - Subject's Global Assessment Mild | 14 participants | 12 participants | 26 participants |
| Disease Characteristic - Subject's Global Assessment Moderate | 66 participants | 24 participants | 90 participants |
| Disease Characteristic - Subject's Global Assessment Severe | 33 participants | 13 participants | 46 participants |
| Disease Characteristic - Subject's Global Assessment Very Noticeable | 109 participants | 63 participants | 172 participants |
| Disease Characteristic- Target Lesion Location Arm | 60 participants | 32 participants | 92 participants |
| Disease Characteristic- Target Lesion Location Leg | 123 participants | 59 participants | 182 participants |
| Disease Characteristic- Target Lesion Location Trunk | 40 participants | 22 participants | 62 participants |
| Gender Female | 91 Participants | 42 Participants | 133 Participants |
| Gender Male | 132 Participants | 71 Participants | 203 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 8 participants | 1 participants | 9 participants |
| Race/Ethnicity, Customized Black | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized Missing | 6 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized Multiracial | 13 participants | 5 participants | 18 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 188 participants | 101 participants | 289 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 223 | 0 / 113 |
| serious Total, serious adverse events | 1 / 223 | 1 / 113 |
Outcome results
Primary
Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Time frame: 8 weeks
Population: Intent-to-Treat (ITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | 31 particpants |
| Vehicle Foam | Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | 8 particpants |
p-value: 0.058Cochran-Mantel-Haenszel
Comparison: Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1p-value: 0.313Breslow-Day Test
Secondary
Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.
Time frame: 8 weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | 51 participants |
| Vehicle Foam | Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | 14 participants |
Comparison: These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.p-value: 0.018Cochran-Mantel-Haenszel
Secondary
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Time frame: 8 weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcipotriene Foam | Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Mild | 2 participants |
| Calcipotriene Foam | Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Moderate | 29 participants |
| Vehicle Foam | Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Mild | 3 participants |
| Vehicle Foam | Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Moderate | 5 participants |
Comparison: Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baselinep-value: 0.167Cochran-Mantel-Haenszel
Comparison: Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baselinep-value: 0.009Cochran-Mantel-Haenszel
Secondary
Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8
Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.
Time frame: 8 weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | 30 participants |
| Vehicle Foam | Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | 5 participants |
Comparison: These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.p-value: 0.008Cochran-Mantel-Haenszel
Secondary
Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8
Erythema was assessed on a 6-point scale. 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: 8 weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | 41 participants |
| Vehicle Foam | Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | 11 participants |
Comparison: These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.p-value: 0.029Cochran-Mantel-Haenszel
Secondary
Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.
Time frame: 8 weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriene Foam | Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | 48 participants |
| Vehicle Foam | Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | 12 participants |
Comparison: These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.p-value: 0.013Cochran-Mantel-Haenszel