Psoriasis
Conditions
Brief summary
The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
Detailed description
Same as above.
Interventions
clobetasol propionate spray, 0.05%, applied topically twice daily
calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area * Overall Disease Severity of at least 3 (moderate)
Exclusion criteria
* Surface area involvement too large (\>20% BSA) * Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Disease Severity Success (ODS) | 8 and 12 weeks | Success was defined as a one-grade improvement in ODS from baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Signs of Psoriasis - Erythema | 2, 4, 8 and 12 weeks |
| Signs of Psoriasis - Scaling | 2, 4, 8 and 12 weeks |
| Signs of Psoriasis - Plaque Elevation | 2, 4, 8 and 12 weeks |
| Percent Change From Baseline in Body Surface Area (% BSA) Affected | 2, 4, 8 and 12 weeks |
| Overall Disease Severity | 2, 4, 8 and 12 weeks |
| Global Improvement Score | 2, 4, 8 and 12 weeks |
| Tolerability Assessment - Telangiectasias | Baseline, 2, 4, 8 and 12 weeks |
| Tolerability Assessment - Stinging/ Burning | Baseline, 2, 4, 8 and 12 weeks |
| Tolerability Assessment - Skin Atrophy | Baseline, 2, 4, 8 and 12 weeks |
| Tolerability Assessment - Folliculitis | Baseline, 2, 4, 8 and 12 weeks |
| Tolerability Assessment - Pruritus | Baseline, 2, 4, 8 and 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequential Treatment Regimen 4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily | 305 |
| Total | 305 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Lost to Follow-up | 18 |
| Overall Study | Treatment Discontinuation | 32 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Sequential Treatment Regimen |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 278 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 273 Participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 305 |
| serious Total, serious adverse events | 9 / 305 |
Outcome results
Primary
Overall Disease Severity Success (ODS)
Success was defined as a one-grade improvement in ODS from baseline.
Time frame: 8 and 12 weeks
Population: The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Overall Disease Severity Success (ODS) | Week 8 | 100.0 percentage of participants |
| Sequential Treatment Regimen | Overall Disease Severity Success (ODS) | Week 12 | 84.1 percentage of participants |
Secondary
Global Improvement Score
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Global Improvement Score | -1:Symptoms | 1 participants |
| Sequential Treatment Regimen | Global Improvement Score | 0:No Change | 4 participants |
| Sequential Treatment Regimen | Global Improvement Score | 1:Minimal Improvement | 9 participants |
| Sequential Treatment Regimen | Global Improvement Score | 2:Definite Improvement | 53 participants |
| Sequential Treatment Regimen | Global Improvement Score | 3:Considerable Improvement | 93 participants |
| Sequential Treatment Regimen | Global Improvement Score | 4:Clearing | 11 participants |
| Week 4 | Global Improvement Score | 4:Clearing | 42 participants |
| Week 4 | Global Improvement Score | 2:Definite Improvement | 26 participants |
| Week 4 | Global Improvement Score | -1:Symptoms | 0 participants |
| Week 4 | Global Improvement Score | 1:Minimal Improvement | 4 participants |
| Week 4 | Global Improvement Score | 0:No Change | 2 participants |
| Week 4 | Global Improvement Score | 3:Considerable Improvement | 96 participants |
| Week 8 | Global Improvement Score | 0:No Change | 10 participants |
| Week 8 | Global Improvement Score | 1:Minimal Improvement | 12 participants |
| Week 8 | Global Improvement Score | 2:Definite Improvement | 43 participants |
| Week 8 | Global Improvement Score | 4:Clearing | 28 participants |
| Week 8 | Global Improvement Score | 3:Considerable Improvement | 77 participants |
| Week 8 | Global Improvement Score | -1:Symptoms | 0 participants |
| Week 12 | Global Improvement Score | 3:Considerable Improvement | 58 participants |
| Week 12 | Global Improvement Score | 4:Clearing | 31 participants |
| Week 12 | Global Improvement Score | 0:No Change | 13 participants |
| Week 12 | Global Improvement Score | 2:Definite Improvement | 49 participants |
| Week 12 | Global Improvement Score | -1:Symptoms | 0 participants |
| Week 12 | Global Improvement Score | 1:Minimal Improvement | 19 participants |
Secondary
Overall Disease Severity
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Overall Disease Severity | Moderate | 31 participants |
| Sequential Treatment Regimen | Overall Disease Severity | Almost Clear | 53 participants |
| Sequential Treatment Regimen | Overall Disease Severity | Severe/Very Severe | 3 participants |
| Sequential Treatment Regimen | Overall Disease Severity | Mild | 83 participants |
| Sequential Treatment Regimen | Overall Disease Severity | Clear | 0 participants |
| Week 4 | Overall Disease Severity | Mild | 53 participants |
| Week 4 | Overall Disease Severity | Moderate | 12 participants |
| Week 4 | Overall Disease Severity | Severe/Very Severe | 0 participants |
| Week 4 | Overall Disease Severity | Almost Clear | 100 participants |
| Week 4 | Overall Disease Severity | Clear | 5 participants |
| Week 8 | Overall Disease Severity | Mild | 88 participants |
| Week 8 | Overall Disease Severity | Clear | 9 participants |
| Week 8 | Overall Disease Severity | Almost Clear | 60 participants |
| Week 8 | Overall Disease Severity | Moderate | 13 participants |
| Week 8 | Overall Disease Severity | Severe/Very Severe | 0 participants |
| Week 12 | Overall Disease Severity | Moderate | 44 participants |
| Week 12 | Overall Disease Severity | Almost Clear | 45 participants |
| Week 12 | Overall Disease Severity | Clear | 11 participants |
| Week 12 | Overall Disease Severity | Mild | 70 participants |
| Week 12 | Overall Disease Severity | Severe/Very Severe | 0 participants |
Secondary
Percent Change From Baseline in Body Surface Area (% BSA) Affected
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sequential Treatment Regimen | Percent Change From Baseline in Body Surface Area (% BSA) Affected | 20.1 Percent Change from Baseline | Standard Deviation 23.6 |
| Week 4 | Percent Change From Baseline in Body Surface Area (% BSA) Affected | 43.1 Percent Change from Baseline | Standard Deviation 30.9 |
| Week 8 | Percent Change From Baseline in Body Surface Area (% BSA) Affected | 46.6 Percent Change from Baseline | Standard Deviation 31.1 |
| Week 12 | Percent Change From Baseline in Body Surface Area (% BSA) Affected | 46.2 Percent Change from Baseline | Standard Deviation 36.1 |
Secondary
Signs of Psoriasis - Erythema
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Signs of Psoriasis - Erythema | Moderate | 35 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Erythema | Almost Clear | 46 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Erythema | Severe/Very Severe | 7 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Erythema | Mild | 82 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Erythema | Clear | 0 participants |
| Week 4 | Signs of Psoriasis - Erythema | Mild | 57 participants |
| Week 4 | Signs of Psoriasis - Erythema | Moderate | 23 participants |
| Week 4 | Signs of Psoriasis - Erythema | Severe/Very Severe | 0 participants |
| Week 4 | Signs of Psoriasis - Erythema | Almost Clear | 81 participants |
| Week 4 | Signs of Psoriasis - Erythema | Clear | 9 participants |
| Week 8 | Signs of Psoriasis - Erythema | Mild | 70 participants |
| Week 8 | Signs of Psoriasis - Erythema | Clear | 13 participants |
| Week 8 | Signs of Psoriasis - Erythema | Almost Clear | 53 participants |
| Week 8 | Signs of Psoriasis - Erythema | Moderate | 32 participants |
| Week 8 | Signs of Psoriasis - Erythema | Severe/Very Severe | 2 participants |
| Week 12 | Signs of Psoriasis - Erythema | Moderate | 53 participants |
| Week 12 | Signs of Psoriasis - Erythema | Almost Clear | 41 participants |
| Week 12 | Signs of Psoriasis - Erythema | Clear | 12 participants |
| Week 12 | Signs of Psoriasis - Erythema | Mild | 60 participants |
| Week 12 | Signs of Psoriasis - Erythema | Severe/Very Severe | 4 participants |
Secondary
Signs of Psoriasis - Plaque Elevation
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Signs of Psoriasis - Plaque Elevation | Almost Clear | 69 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Plaque Elevation | Clear | 22 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Plaque Elevation | Severe/Very Severe | 1 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Plaque Elevation | Mild | 54 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Plaque Elevation | Moderate | 24 participants |
| Week 4 | Signs of Psoriasis - Plaque Elevation | Mild | 36 participants |
| Week 4 | Signs of Psoriasis - Plaque Elevation | Moderate | 9 participants |
| Week 4 | Signs of Psoriasis - Plaque Elevation | Clear | 46 participants |
| Week 4 | Signs of Psoriasis - Plaque Elevation | Severe/Very Severe | 1 participants |
| Week 4 | Signs of Psoriasis - Plaque Elevation | Almost Clear | 78 participants |
| Week 8 | Signs of Psoriasis - Plaque Elevation | Mild | 68 participants |
| Week 8 | Signs of Psoriasis - Plaque Elevation | Almost Clear | 50 participants |
| Week 8 | Signs of Psoriasis - Plaque Elevation | Clear | 35 participants |
| Week 8 | Signs of Psoriasis - Plaque Elevation | Moderate | 17 participants |
| Week 8 | Signs of Psoriasis - Plaque Elevation | Severe/Very Severe | 0 participants |
| Week 12 | Signs of Psoriasis - Plaque Elevation | Moderate | 39 participants |
| Week 12 | Signs of Psoriasis - Plaque Elevation | Almost Clear | 45 participants |
| Week 12 | Signs of Psoriasis - Plaque Elevation | Clear | 24 participants |
| Week 12 | Signs of Psoriasis - Plaque Elevation | Mild | 61 participants |
| Week 12 | Signs of Psoriasis - Plaque Elevation | Severe/Very Severe | 1 participants |
Secondary
Signs of Psoriasis - Scaling
Time frame: 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Signs of Psoriasis - Scaling | Moderate | 19 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Scaling | Almost Clear | 61 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Scaling | Severe/Very Severe | 4 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Scaling | Mild | 63 participants |
| Sequential Treatment Regimen | Signs of Psoriasis - Scaling | Clear | 25 participants |
| Week 4 | Signs of Psoriasis - Scaling | Mild | 37 participants |
| Week 4 | Signs of Psoriasis - Scaling | Moderate | 9 participants |
| Week 4 | Signs of Psoriasis - Scaling | Severe/Very Severe | 0 participants |
| Week 4 | Signs of Psoriasis - Scaling | Almost Clear | 83 participants |
| Week 4 | Signs of Psoriasis - Scaling | Clear | 41 participants |
| Week 8 | Signs of Psoriasis - Scaling | Mild | 71 participants |
| Week 8 | Signs of Psoriasis - Scaling | Clear | 36 participants |
| Week 8 | Signs of Psoriasis - Scaling | Almost Clear | 53 participants |
| Week 8 | Signs of Psoriasis - Scaling | Moderate | 9 participants |
| Week 8 | Signs of Psoriasis - Scaling | Severe/Very Severe | 1 participants |
| Week 12 | Signs of Psoriasis - Scaling | Moderate | 26 participants |
| Week 12 | Signs of Psoriasis - Scaling | Almost Clear | 56 participants |
| Week 12 | Signs of Psoriasis - Scaling | Clear | 31 participants |
| Week 12 | Signs of Psoriasis - Scaling | Mild | 54 participants |
| Week 12 | Signs of Psoriasis - Scaling | Severe/Very Severe | 3 participants |
Secondary
Tolerability Assessment - Folliculitis
Time frame: Baseline, 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Tolerability Assessment - Folliculitis | Absent | 303 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Folliculitis | Present | 2 participants |
| Week 4 | Tolerability Assessment - Folliculitis | Absent | 286 participants |
| Week 4 | Tolerability Assessment - Folliculitis | Present | 2 participants |
| Week 8 | Tolerability Assessment - Folliculitis | Present | 11 participants |
| Week 8 | Tolerability Assessment - Folliculitis | Absent | 274 participants |
| Week 12 | Tolerability Assessment - Folliculitis | Present | 3 participants |
| Week 12 | Tolerability Assessment - Folliculitis | Absent | 271 participants |
| Week 12 | Tolerability Assessment - Folliculitis | Absent | 232 participants |
| Week 12 | Tolerability Assessment - Folliculitis | Present | 3 participants |
Secondary
Tolerability Assessment - Pruritus
Time frame: Baseline, 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Tolerability Assessment - Pruritus | None | 74 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Pruritus | Mild | 84 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Pruritus | Moderate | 84 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Pruritus | Severe | 63 participants |
| Week 4 | Tolerability Assessment - Pruritus | None | 179 participants |
| Week 4 | Tolerability Assessment - Pruritus | Severe | 5 participants |
| Week 4 | Tolerability Assessment - Pruritus | Mild | 91 participants |
| Week 4 | Tolerability Assessment - Pruritus | Moderate | 13 participants |
| Week 8 | Tolerability Assessment - Pruritus | Severe | 0 participants |
| Week 8 | Tolerability Assessment - Pruritus | Mild | 56 participants |
| Week 8 | Tolerability Assessment - Pruritus | Moderate | 9 participants |
| Week 8 | Tolerability Assessment - Pruritus | None | 220 participants |
| Week 12 | Tolerability Assessment - Pruritus | None | 172 participants |
| Week 12 | Tolerability Assessment - Pruritus | Mild | 66 participants |
| Week 12 | Tolerability Assessment - Pruritus | Severe | 5 participants |
| Week 12 | Tolerability Assessment - Pruritus | Moderate | 31 participants |
| Week 12 | Tolerability Assessment - Pruritus | Severe | 10 participants |
| Week 12 | Tolerability Assessment - Pruritus | Moderate | 32 participants |
| Week 12 | Tolerability Assessment - Pruritus | Mild | 65 participants |
| Week 12 | Tolerability Assessment - Pruritus | None | 128 participants |
Secondary
Tolerability Assessment - Skin Atrophy
Time frame: Baseline, 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Tolerability Assessment - Skin Atrophy | Absent | 303 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Skin Atrophy | Present | 2 participants |
| Week 4 | Tolerability Assessment - Skin Atrophy | Absent | 286 participants |
| Week 4 | Tolerability Assessment - Skin Atrophy | Present | 2 participants |
| Week 8 | Tolerability Assessment - Skin Atrophy | Absent | 278 participants |
| Week 8 | Tolerability Assessment - Skin Atrophy | Present | 7 participants |
| Week 12 | Tolerability Assessment - Skin Atrophy | Present | 4 participants |
| Week 12 | Tolerability Assessment - Skin Atrophy | Absent | 270 participants |
| Week 12 | Tolerability Assessment - Skin Atrophy | Absent | 233 participants |
| Week 12 | Tolerability Assessment - Skin Atrophy | Present | 2 participants |
Secondary
Tolerability Assessment - Stinging/ Burning
Time frame: Baseline, 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Tolerability Assessment - Stinging/ Burning | Moderate | 31 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Stinging/ Burning | None | 200 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Stinging/ Burning | Mild | 44 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Stinging/ Burning | Severe | 30 participants |
| Week 4 | Tolerability Assessment - Stinging/ Burning | Mild | 42 participants |
| Week 4 | Tolerability Assessment - Stinging/ Burning | None | 232 participants |
| Week 4 | Tolerability Assessment - Stinging/ Burning | Severe | 1 participants |
| Week 4 | Tolerability Assessment - Stinging/ Burning | Moderate | 13 participants |
| Week 8 | Tolerability Assessment - Stinging/ Burning | None | 245 participants |
| Week 8 | Tolerability Assessment - Stinging/ Burning | Severe | 1 participants |
| Week 8 | Tolerability Assessment - Stinging/ Burning | Mild | 34 participants |
| Week 8 | Tolerability Assessment - Stinging/ Burning | Moderate | 4 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | None | 234 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Severe | 3 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Moderate | 19 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Mild | 18 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Severe | 3 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | None | 200 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Mild | 24 participants |
| Week 12 | Tolerability Assessment - Stinging/ Burning | Moderate | 8 participants |
Secondary
Tolerability Assessment - Telangiectasias
Time frame: Baseline, 2, 4, 8 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequential Treatment Regimen | Tolerability Assessment - Telangiectasias | None | 303 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Telangiectasias | Mild | 1 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Telangiectasias | Severe | 1 participants |
| Sequential Treatment Regimen | Tolerability Assessment - Telangiectasias | Moderate | 0 participants |
| Week 4 | Tolerability Assessment - Telangiectasias | Moderate | 0 participants |
| Week 4 | Tolerability Assessment - Telangiectasias | None | 284 participants |
| Week 4 | Tolerability Assessment - Telangiectasias | Mild | 4 participants |
| Week 4 | Tolerability Assessment - Telangiectasias | Severe | 0 participants |
| Week 8 | Tolerability Assessment - Telangiectasias | Mild | 2 participants |
| Week 8 | Tolerability Assessment - Telangiectasias | Moderate | 0 participants |
| Week 8 | Tolerability Assessment - Telangiectasias | Severe | 0 participants |
| Week 8 | Tolerability Assessment - Telangiectasias | None | 283 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Mild | 1 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | None | 273 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Moderate | 0 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Severe | 0 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Mild | 5 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | None | 230 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Severe | 0 participants |
| Week 12 | Tolerability Assessment - Telangiectasias | Moderate | 0 participants |