Plaque-Type Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Detailed description
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
Interventions
DRUGOlux-E Foam
Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.
DRUGClobex lotion
Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body surface area (BSA) affected with psoriasis between 4% and 20% . * Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion. * Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3). * Definitive diagnosis of elbow and/or knee plaque-type psoriasis. * Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed. * Male or female, 18 years of age or older at the time that the consent form was signed. * Able to complete the study and comply with study instructions. * Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.
Exclusion criteria
* Use of any emollient applied to psoriasis plaques treated with the study medication during the study. * Other serious skin disorder or any chronic medical condition that is not well controlled. * Female subjects who are pregnant, trying to become pregnant or lactating. * Any major illness within 30 days prior to the baseline visit. * Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) | Baseline to day 15 | Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At Least a 2 Grade Improvement Psoriasis Grading Scale | Baseline, days 3, 8, 15 | Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). |
| At Least a 3 Grade Improvement Psoriasis Grading Scale | Baseline, days 3, 8, 15 | Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). |
| At Least 1 Grade Improvement in the Psoriasis Global Assessment | Baseline, days 3, 8, 15 | Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. |
| At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Baseline, days 3, 8, 15 | Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. |
| At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Baseline, days 3, 8, 15 | Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. |
| At Least 1 Grade Improvement in Subject's Global Assessment | Baseline, days 3, 8, 15 | Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. |
| At Least a 2 Grade Improvement in Subject's Global Assessment | Baseline, days 3, 8, 15 | Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. |
| At Least a 3 Grade Improvement in Subject's Global Assessment | Baseline, days 3, 8, 15 | Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. |
| At Least 1 Grade Improvement Psoriasis Grading Scale | Baseline, days 3 and 8 | Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). |
| Dermatology Quality of Life - Symptoms and Feelings | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life |
| Dermatology Quality of Life - Daily Activities | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life |
| Dermatology Quality of Life - Leisure | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life |
| Dermatology Quality of Life - Work and School | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life |
| Dermatology Quality of Life - Personal Relationships | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life |
| Dermatology Quality of Life - Treatment | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life |
| Total Dermatology Life Quality Index (DLQI) Score | Baseline, Days 3, 8, 15 | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life |
| Dermatology Life Quality Index (DLQI) Categories | Days 3, 8, 15 | Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life. |
| Median Change in Psoriasis Grading Scale | Baseline, Days 3, 8, 15 | Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. |
Countries
United States
Participant flow
Recruitment details
Clinical research center
Participants by arm
| Arm | Count |
|---|---|
| Olux-E Foam Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser. | 17 |
| Clobex Lotion Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Olux-E Foam | Clobex Lotion | Total |
|---|---|---|---|
| Age, Customized | 48.2 years STANDARD_DEVIATION 11.7 | 48.6 years STANDARD_DEVIATION 13 | 48.4 years STANDARD_DEVIATION 12.2 |
| Body Mass Index | 31.2 kg/m^2 STANDARD_DEVIATION 6.4 | 30.0 kg/m^2 STANDARD_DEVIATION 8.8 | 30.6 kg/m^2 STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 15 Participants | 31 Participants |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 2 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Time frame: Baseline to day 15
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) | 15 participants |
| Clobex Lotion | At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) | 14 participants |
Secondary
At Least 1 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least 1 Grade Improvement in Subject's Global Assessment | Day 3 | 8 participants |
| Olux-E Foam | At Least 1 Grade Improvement in Subject's Global Assessment | Day 8 | 15 participants |
| Olux-E Foam | At Least 1 Grade Improvement in Subject's Global Assessment | Day 15 | 15 participants |
| Clobex Lotion | At Least 1 Grade Improvement in Subject's Global Assessment | Day 3 | 12 participants |
| Clobex Lotion | At Least 1 Grade Improvement in Subject's Global Assessment | Day 8 | 16 participants |
| Clobex Lotion | At Least 1 Grade Improvement in Subject's Global Assessment | Day 15 | 17 participants |
p-value: 0.1449Chi-squared
p-value: 0.1634Chi-squared
p-value: 0.5454Chi-squared
Secondary
At Least 1 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 6 participants |
| Olux-E Foam | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 10 participants |
| Olux-E Foam | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 14 participants |
| Clobex Lotion | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 7 participants |
| Clobex Lotion | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 13 participants |
| Clobex Lotion | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 14 participants |
Secondary
At Least 1 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time frame: Baseline, days 3 and 8
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least 1 Grade Improvement Psoriasis Grading Scale | Day 3 | 9 participants |
| Olux-E Foam | At Least 1 Grade Improvement Psoriasis Grading Scale | Day 8 | 14 participants |
| Clobex Lotion | At Least 1 Grade Improvement Psoriasis Grading Scale | Day 3 | 10 participants |
| Clobex Lotion | At Least 1 Grade Improvement Psoriasis Grading Scale | Day 8 | 14 participants |
p-value: 0.7298Chi-squared
p-value: 1Chi-squared
Secondary
At Least a 2 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 3 | 4 participants |
| Olux-E Foam | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 8 | 10 participants |
| Olux-E Foam | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 15 | 13 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 3 | 3 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 8 | 11 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in Subject's Global Assessment | Day 15 | 14 participants |
p-value: 0.6715Chi-squared
p-value: 0.7242Chi-squared
p-value: 0.6715Chi-squared
Secondary
At Least a 2 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 0 participants |
| Olux-E Foam | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 6 participants |
| Olux-E Foam | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 3 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 1 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 7 participants |
| Clobex Lotion | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 10 participants |
p-value: 0.3101Chi-squared
p-value: 0.7242Chi-squared
p-value: 0.0135Chi-squared
Secondary
At Least a 2 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 3 | 2 participants |
| Olux-E Foam | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 8 | 5 participants |
| Olux-E Foam | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 15 | 5 participants |
| Clobex Lotion | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 3 | 1 participants |
| Clobex Lotion | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 8 | 13 participants |
| Clobex Lotion | At Least a 2 Grade Improvement Psoriasis Grading Scale | Day 15 | 13 participants |
p-value: 0.7298Chi-squared
p-value: 0.006Chi-squared
p-value: 0.006Chi-squared
Secondary
At Least a 3 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 3 | 0 participants |
| Olux-E Foam | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 8 | 6 participants |
| Olux-E Foam | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 15 | 8 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 3 | 0 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 8 | 8 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in Subject's Global Assessment | Day 15 | 11 participants |
p-value: 0.4858Chi-squared
p-value: 0.3001Chi-squared
Secondary
At Least a 3 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 0 participants |
| Olux-E Foam | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 0 participants |
| Olux-E Foam | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 0 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 3 | 0 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 8 | 0 participants |
| Clobex Lotion | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Day 15 | 3 participants |
Secondary
At Least a 3 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time frame: Baseline, days 3, 8, 15
Population: Intent to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | At Least a 3 Grade Improvement Psoriasis Grading Scale | Day 8 | 0 participants |
| Olux-E Foam | At Least a 3 Grade Improvement Psoriasis Grading Scale | Day 15 | 0 participants |
| Clobex Lotion | At Least a 3 Grade Improvement Psoriasis Grading Scale | Day 8 | 2 participants |
| Clobex Lotion | At Least a 3 Grade Improvement Psoriasis Grading Scale | Day 15 | 4 participants |
p-value: 0.0332Chi-squared
Secondary
Dermatology Life Quality Index (DLQI) Categories
Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.
Time frame: Days 3, 8, 15
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 0 -1 No effect | 5 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 2- 5 Small effect | 6 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 6- 10 Moderate effect | 5 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 11- 20 Very large effect | 0 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 0 -1 No effect | 9 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 2- 5 Small effect | 4 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 6- 10 Moderate effect | 3 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 11- 20 Very large effect | 1 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 0 -1 No effect | 11 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 2- 5 Small effect | 3 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 6- 10 Moderate effect | 2 participants |
| Olux-E Foam | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 11- 20 Very large effect | 1 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 6- 10 Moderate effect | 1 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 0 -1 No effect | 4 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 6- 10 Moderate effect | 3 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 2- 5 Small effect | 4 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 2- 5 Small effect | 5 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 6- 10 Moderate effect | 7 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 11- 20 Very large effect | 1 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 3 Score 11- 20 Very large effect | 2 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 11- 20 Very large effect | 1 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 0 -1 No effect | 7 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 15 Score 0 -1 No effect | 10 participants |
| Clobex Lotion | Dermatology Life Quality Index (DLQI) Categories | Day 8 Score 2- 5 Small effect | 6 participants |
Secondary
Dermatology Quality of Life - Daily Activities
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Daily Activities | Day 3, n=16, 17 | 0.56 units on a scale | Standard Deviation 0.96 |
| Olux-E Foam | Dermatology Quality of Life - Daily Activities | Day 8, n=17, 17 | 0.53 units on a scale | Standard Deviation 0.94 |
| Olux-E Foam | Dermatology Quality of Life - Daily Activities | Day 15, n=17, 17 | 0.53 units on a scale | Standard Deviation 1.07 |
| Clobex Lotion | Dermatology Quality of Life - Daily Activities | Day 3, n=16, 17 | 1.41 units on a scale | Standard Deviation 1.23 |
| Clobex Lotion | Dermatology Quality of Life - Daily Activities | Day 8, n=17, 17 | 0.88 units on a scale | Standard Deviation 1.05 |
| Clobex Lotion | Dermatology Quality of Life - Daily Activities | Day 15, n=17, 17 | 0.82 units on a scale | Standard Deviation 1.29 |
Secondary
Dermatology Quality of Life - Leisure
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Leisure | Day 3, n=16, 17 | 0.5 units on a scale | Standard Deviation 0.97 |
| Olux-E Foam | Dermatology Quality of Life - Leisure | Day 8, n=17, 17 | 0.47 units on a scale | Standard Deviation 0.94 |
| Olux-E Foam | Dermatology Quality of Life - Leisure | Day 15, n=17, 17 | 0.35 units on a scale | Standard Deviation 1 |
| Clobex Lotion | Dermatology Quality of Life - Leisure | Day 3, n=16, 17 | 0.94 units on a scale | Standard Deviation 1.3 |
| Clobex Lotion | Dermatology Quality of Life - Leisure | Day 8, n=17, 17 | 0.41 units on a scale | Standard Deviation 0.87 |
| Clobex Lotion | Dermatology Quality of Life - Leisure | Day 15, n=17, 17 | 0.24 units on a scale | Standard Deviation 0.56 |
Secondary
Dermatology Quality of Life - Personal Relationships
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Personal Relationships | Day 3, n=15, 17 | 0.33 units on a scale | Standard Deviation 0.49 |
| Olux-E Foam | Dermatology Quality of Life - Personal Relationships | Day 8, n=16, 17 | 0.25 units on a scale | Standard Deviation 0.45 |
| Olux-E Foam | Dermatology Quality of Life - Personal Relationships | Day 15, n=17, 17 | 0.18 units on a scale | Standard Deviation 0.53 |
| Clobex Lotion | Dermatology Quality of Life - Personal Relationships | Day 3, n=15, 17 | 0.41 units on a scale | Standard Deviation 0.8 |
| Clobex Lotion | Dermatology Quality of Life - Personal Relationships | Day 8, n=16, 17 | 0.29 units on a scale | Standard Deviation 0.77 |
| Clobex Lotion | Dermatology Quality of Life - Personal Relationships | Day 15, n=17, 17 | 0.12 units on a scale | Standard Deviation 0.33 |
Secondary
Dermatology Quality of Life - Symptoms and Feelings
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Symptoms and Feelings | Day 3, n=16, 17 | 1.94 units on a scale | Standard Deviation 1.12 |
| Olux-E Foam | Dermatology Quality of Life - Symptoms and Feelings | Day 8, n=17, 17 | 1.06 units on a scale | Standard Deviation 1.2 |
| Olux-E Foam | Dermatology Quality of Life - Symptoms and Feelings | Day 15, n=17, 17 | 0.82 units on a scale | Standard Deviation 0.95 |
| Clobex Lotion | Dermatology Quality of Life - Symptoms and Feelings | Day 3, n=16, 17 | 2.41 units on a scale | Standard Deviation 1.7 |
| Clobex Lotion | Dermatology Quality of Life - Symptoms and Feelings | Day 8, n=17, 17 | 1.35 units on a scale | Standard Deviation 1.32 |
| Clobex Lotion | Dermatology Quality of Life - Symptoms and Feelings | Day 15, n=17, 17 | 0.94 units on a scale | Standard Deviation 1.14 |
Secondary
Dermatology Quality of Life - Treatment
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Treatment | Day 3, n=16, 17 | 0.31 units on a scale | Standard Deviation 0.6 |
| Olux-E Foam | Dermatology Quality of Life - Treatment | Day 8, n=17, 17 | 0.29 units on a scale | Standard Deviation 0.59 |
| Olux-E Foam | Dermatology Quality of Life - Treatment | Day 15, n=17, 17 | 0.18 units on a scale | Standard Deviation 0.39 |
| Clobex Lotion | Dermatology Quality of Life - Treatment | Day 3, n=16, 17 | 0.35 units on a scale | Standard Deviation 0.61 |
| Clobex Lotion | Dermatology Quality of Life - Treatment | Day 8, n=17, 17 | 0.24 units on a scale | Standard Deviation 0.44 |
| Clobex Lotion | Dermatology Quality of Life - Treatment | Day 15, n=17, 17 | 0.24 units on a scale | Standard Deviation 0.44 |
Secondary
Dermatology Quality of Life - Work and School
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Dermatology Quality of Life - Work and School | Day 3, n=15, 17 | 0.13 units on a scale | Standard Deviation 0.35 |
| Olux-E Foam | Dermatology Quality of Life - Work and School | Day 8, n=16, 17 | 0.06 units on a scale | Standard Deviation 0.25 |
| Olux-E Foam | Dermatology Quality of Life - Work and School | Day 15, n=17, 17 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clobex Lotion | Dermatology Quality of Life - Work and School | Day 3, n=15, 17 | 0.24 units on a scale | Standard Deviation 0.56 |
| Clobex Lotion | Dermatology Quality of Life - Work and School | Day 8, n=16, 17 | 0.12 units on a scale | Standard Deviation 0.33 |
| Clobex Lotion | Dermatology Quality of Life - Work and School | Day 15, n=17, 17 | 0.06 units on a scale | Standard Deviation 0.24 |
Secondary
Median Change in Psoriasis Grading Scale
Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Time frame: Baseline, Days 3, 8, 15
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Olux-E Foam | Median Change in Psoriasis Grading Scale | Day 3 | -1 unites on a scale |
| Olux-E Foam | Median Change in Psoriasis Grading Scale | Day 8 | -1 unites on a scale |
| Olux-E Foam | Median Change in Psoriasis Grading Scale | Day 15 | -1 unites on a scale |
| Clobex Lotion | Median Change in Psoriasis Grading Scale | Day 3 | -1 unites on a scale |
| Clobex Lotion | Median Change in Psoriasis Grading Scale | Day 8 | -2 unites on a scale |
| Clobex Lotion | Median Change in Psoriasis Grading Scale | Day 15 | -2 unites on a scale |
Secondary
Total Dermatology Life Quality Index (DLQI) Score
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life
Time frame: Baseline, Days 3, 8, 15
Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Total Dermatology Life Quality Index (DLQI) Score | Day 3 | 3.75 units on a scale | Standard Deviation 2.82 |
| Olux-E Foam | Total Dermatology Life Quality Index (DLQI) Score | Day 8 | 2.65 units on a scale | Standard Deviation 3.44 |
| Olux-E Foam | Total Dermatology Life Quality Index (DLQI) Score | Day 15 | 2.12 units on a scale | Standard Deviation 3.64 |
| Clobex Lotion | Total Dermatology Life Quality Index (DLQI) Score | Day 3 | 5.76 units on a scale | Standard Deviation 4.64 |
| Clobex Lotion | Total Dermatology Life Quality Index (DLQI) Score | Day 8 | 3.29 units on a scale | Standard Deviation 3.64 |
| Clobex Lotion | Total Dermatology Life Quality Index (DLQI) Score | Day 15 | 2.41 units on a scale | Standard Deviation 3 |