Psoriasis
Conditions
Keywords
Psoriasis, Plaque Type Psoriasis
Brief summary
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
Detailed description
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.
Interventions
DRUGClobetasol propionate foam
Topical Clobetasol propionate foam
DRUGVehicle foam
Vehicle foam does not include the active drug.
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
* Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study. * Mild to moderate, plaque-type psoriasis * Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness * Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion criteria
* Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control * Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations * Subjects who have not complied with the proper wash-out periods for prohibited medications * Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study * Skin disease/disorder that might interfere with the study related diagnosis or evaluations * Evidence of recent alcohol or drug abuse * History of poor cooperation, non-compliance with medical treatment or unreliability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 | Week 2 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. |
| Number of Participants With an Erythema Score of 0 or 1 at Week 2 | Week 2 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. |
| Number of Participants With a Scaling Score of 0 or 1 at Week 2 | Week 2 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. |
| Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 | Week 2 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. |
| Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 | Week 2 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. |
| Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) | Baseline (Week 0) and Week 2 | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (\>2 cm squared \[cm\^2\]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. |
| Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected | Baseline (Week 0) and Week 2 | Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. Data for this outcome measure were not collected; thus, no data were analyzed. |
| Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. |
| Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0) and Week 4 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. |
| Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0) and Week 4 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. |
| Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0) and Week 4 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. |
| Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0) and Week 4 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. |
| Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Baseline (Week 0) and Week 4 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. |
| Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) | Baseline (Week 0) and Week 4 | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (\>2 cm squared \[cm\^2\]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. |
| Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected | Baseline (Week 0) and Week 4 | Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. Data for this outcome measure were not collected; thus, no data were analyzed. |
| Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | Week 1 and Week 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. |
Countries
United States
Participant flow
Pre-assignment details
A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.
Participants by arm
| Arm | Count |
|---|---|
| Olux-E Foam Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening \[BD\]) for four weeks to the affected area on the scalp and body | 28 |
| Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body | 30 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Olux-E Foam | Vehicle Foam | Total |
|---|---|---|---|
| Age, Continuous | 54.2 Years STANDARD_DEVIATION 20 | 47.2 Years STANDARD_DEVIATION 13.4 | 50.6 Years STANDARD_DEVIATION 17.1 |
| Race/Ethnicity, Customized Asian | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Black | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 23 participants | 23 participants | 46 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other (not included above; including mixed race) | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 27 | 6 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 30 |
Outcome results
Primary
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time frame: Weeks 1, 2, and 4
Population: Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 1, n=26, 30 | 6 participants |
| Olux-E Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 2, n=26, 30 | 19 participants |
| Olux-E Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 4, n=27, 28 | 12 participants |
| Vehicle Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 1, n=26, 30 | 2 participants |
| Vehicle Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 2, n=26, 30 | 3 participants |
| Vehicle Foam | Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | Week 4, n=27, 28 | 2 participants |
p-value: 0.1269Fisher Exact
p-value: <0.0001Chi-squared
p-value: 0.0015Chi-squared
Secondary
Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected
Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time frame: Baseline (Week 0) and Week 2
Population: ITT Population
Secondary
Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (\>2 cm squared \[cm\^2\]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100.
Time frame: Baseline (Week 0) and Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olux-E Foam | Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) | -30.5 Percent change in scores on a scale | Standard Deviation 155.8 |
| Vehicle Foam | Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) | 40.1 Percent change in scores on a scale | Standard Deviation 442 |
Secondary
Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected
Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population
Secondary
Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (\>2 cm squared \[cm\^2\]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value \* 100.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olux-E Foam | Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) | -6.8 Percent change in scores on a scale | Standard Deviation 213.5 |
| Vehicle Foam | Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) | -40.2 Percent change in scores on a scale | Standard Deviation 67.4 |
Secondary
Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Olux-E Foam | Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 6 participants |
| Vehicle Foam | Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Vehicle Foam | Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 1 participants |
Secondary
Number of Participants With an Erythema Score of 0 or 1 at Week 2
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time frame: Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With an Erythema Score of 0 or 1 at Week 2 | 6 participants |
| Vehicle Foam | Number of Participants With an Erythema Score of 0 or 1 at Week 2 | 1 participants |
Secondary
Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Olux-E Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 12 participants |
| Vehicle Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Vehicle Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 2 participants |
Secondary
Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time frame: Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 | 16 participants |
| Vehicle Foam | Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 | 4 participants |
Secondary
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 8 participants |
| Olux-E Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 19 participants |
| Vehicle Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 9 participants |
| Vehicle Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 17 participants |
Secondary
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time frame: Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 | 21 participants |
| Vehicle Foam | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 | 17 participants |
Secondary
Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Olux-E Foam | Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 6 participants |
| Vehicle Foam | Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Vehicle Foam | Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | Week 4, n=27, 28 | 4 participants |
Secondary
Number of Participants With a Scaling Score of 0 or 1 at Week 2
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time frame: Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With a Scaling Score of 0 or 1 at Week 2 | 11 participants |
| Vehicle Foam | Number of Participants With a Scaling Score of 0 or 1 at Week 2 | 5 participants |
Secondary
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time frame: Baseline (Week 0) and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Olux-E Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Week 4, n=27, 28 | 7 participants |
| Vehicle Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Baseline (Week 0), n=28, 30 | 0 participants |
| Vehicle Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Week 4, n=27, 28 | 1 participants |
Secondary
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time frame: Week 2
Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 | 5 participants |
| Vehicle Foam | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 | 1 participants |
Secondary
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time frame: Weeks 1, 2, and 4
Population: ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 1, n=26, 30 | 19 participants |
| Olux-E Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 2, n=26, 30 | 21 participants |
| Olux-E Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 4, n=27, 28 | 15 participants |
| Vehicle Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 1, n=26, 30 | 6 participants |
| Vehicle Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 2, n=26, 30 | 9 participants |
| Vehicle Foam | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | Week 4, n=27, 28 | 8 participants |
Secondary
Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time frame: Week 1 and Week 4
Population: ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | Week 1, n=26, 30 | 6 participants |
| Olux-E Foam | Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | Week 4, n=27, 28 | 12 participants |
| Vehicle Foam | Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | Week 1, n=26, 30 | 2 participants |
| Vehicle Foam | Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | Week 4, n=27, 28 | 2 participants |