Scalp Psoriasis
Conditions
Brief summary
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years
Interventions
Once daily application
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area * A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment * Serum albumin-corrected calcium below the upper reference limit at screening visit 2
Exclusion criteria
* A history of hypersensitivity to any component of the LEO 80185 gel * Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study * Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study * Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study: * etanercept - within 4 weeks prior to Visit 1 * adalimumab, alefacept, infliximab - within 2 months prior to Visit 1 * ustekinumab - within 4 months prior to Visit 1 * experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 * Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study * UVB therapy within 2 weeks prior to Visit 1 or during the study * Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study * Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study * Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study * Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis * Subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds * Planned excessive exposure to sun during the study that may affect scalp psoriasis * Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Adverse Drug Reactions (ADRs) | Throughout trial, up to 8-weeks | Adverse events for which the investigator did not describe the causal relationship to IP as not related |
| Change in Albumincorrected Serum Calcium From Baseline to Week 4 | Baseline and week 4 | Change in albumincorrected serum calcium from Baseline to week 4 |
| Change in Albumincorrected Serum Calcium From Baseline to Week 8 | Baseline and week 8 | Change in albumincorrected serum calcium from Baseline to week 8 |
| Change in Albumincorrected Serum Calcium From Baseline to End of Treatment | Baseline and End of treatment (up to 8 weeks) | Change in albumincorrected serum calcium from Baseline to end of treatment |
| Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 | Baseline and week 4 | Change in 24-hour urinary calcium excretion from Baseline to week 4 |
| Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 | Baseline and week 8 | Change in 24-hour urinary calcium excretion from Baseline to week 8 |
| Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment | Baseline and End of treatment (up to 8 weeks) | Change in 24-hour urinary calcium excretion from Baseline to end of treatment |
| Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 | Baseline and week 4 | Change in urinary calcium:creatinine ratio from Baseline to week 4 |
| Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 | Baseline and week 8 | Change in urinary calcium:creatinine ratio from Baseline to week 8 |
| Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment | Baseline and End of treatment (up to 8 weeks) | Change in urinary calcium:creatinine ratio from Baseline to end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2 | Week 2 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe. |
| Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4 | Week 4 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. |
| Change in Plasma PTH From Baseline to Week 4 | Baseline and week 4 | Change in plasma PTH (parathyroid hormone) from Baseline to week 4 |
| Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment | End of treatment (up to 8 weeks) | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. |
| Withdrawal | Week 4 and 8 | How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason |
| Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8 | Week 8 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. |
| Change in Plasma PTH From Baseline to Week 8 | Baseline and week 8 | Change in plasma PTH (parathyroid hormone) from Baseline to week 8 |
| Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2 | Week 2 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe. |
| Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4 | Week 4 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4 |
| Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8 | Week 8 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8 |
| Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment | End of treatment (up to 8 weeks) | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment |
| Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2 | Baseline and week 2 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). |
| Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4 | Baseline and week 4 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points. |
| Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8 | Baseline and week 8 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). |
| Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment. | Baseline and End of treatment (up to 8 weeks) | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). |
Countries
Canada, France, United Kingdom
Participant flow
Recruitment details
Start date: 22-Nov-2010 Completion date: 15-Oct-2012
Pre-assignment details
Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.
Participants by arm
| Arm | Count |
|---|---|
| LEO 80185 Gel Once Daily Application Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | LEO 80185 Gel Once Daily Application |
|---|---|
| Age, Categorical <=18 years | 78 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.6 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment Canada | 37 participants |
| Region of Enrollment France | 22 participants |
| Region of Enrollment United Kingdom | 19 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment | -0.03 mmol/24hr | Standard Deviation 1.43 |
Primary
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Change in 24-hour urinary calcium excretion from Baseline to week 4
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 | -0.01 mmol/24hr | Standard Deviation 1.54 |
Primary
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Change in 24-hour urinary calcium excretion from Baseline to week 8
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 | 0.03 mmol/24hr | Standard Deviation 1.42 |
Primary
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
Change in albumincorrected serum calcium from Baseline to end of treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Albumincorrected Serum Calcium From Baseline to End of Treatment | 0.000 mmol/L | Standard Error 0.101 |
Primary
Change in Albumincorrected Serum Calcium From Baseline to Week 4
Change in albumincorrected serum calcium from Baseline to week 4
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Albumincorrected Serum Calcium From Baseline to Week 4 | -0.014 mmol/L | Standard Deviation 0.139 |
Primary
Change in Albumincorrected Serum Calcium From Baseline to Week 8
Change in albumincorrected serum calcium from Baseline to week 8
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Albumincorrected Serum Calcium From Baseline to Week 8 | -0.002 mmol/L | Standard Deviation 0.098 |
Primary
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
Change in urinary calcium:creatinine ratio from Baseline to end of treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment | -0.1156 mmol/g | Standard Deviation 1.679 |
Primary
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Change in urinary calcium:creatinine ratio from Baseline to week 4
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 | -0.269 mmol/g | Standard Deviation 1.684 |
Primary
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Change in urinary calcium:creatinine ratio from Baseline to week 8
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 | -0.003 mmol/g | Standard Deviation 1.5 |
Primary
Percentage of Subjects With Adverse Drug Reactions (ADRs)
Adverse events for which the investigator did not describe the causal relationship to IP as not related
Time frame: Throughout trial, up to 8-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Percentage of Subjects With Adverse Drug Reactions (ADRs) | 6.4 percent subjects |
Secondary
Change in Plasma PTH From Baseline to Week 4
Change in plasma PTH (parathyroid hormone) from Baseline to week 4
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Plasma PTH From Baseline to Week 4 | 1.2 ng/L | Standard Deviation 16 |
Secondary
Change in Plasma PTH From Baseline to Week 8
Change in plasma PTH (parathyroid hormone) from Baseline to week 8
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Change in Plasma PTH From Baseline to Week 8 | -2.8 ng/L | Standard Deviation 13 |
Secondary
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Time frame: Baseline and End of treatment (up to 8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment. | -80.4 percent of change | Standard Deviation 22.6 |
Secondary
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Time frame: Baseline and week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2 | -62.7 percentage of change | Standard Deviation 22.3 |
Secondary
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8 | -76.6 percent change | Standard Deviation 23.5 |
Secondary
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80185 Gel Once Daily Application | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4 | -72.1 percent of change | Standard Deviation 21.4 |
Secondary
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Time frame: End of treatment (up to 8 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment | 68 participants |
Secondary
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.
Time frame: Week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2 | 44 participants |
Secondary
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4 | 55 participants |
Secondary
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8 | 51 participants |
Secondary
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment
Time frame: End of treatment (up to 8 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment | 66 participants |
Secondary
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.
Time frame: Week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2 | 37 participants |
Secondary
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4 | 59 participants |
Secondary
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8 | 49 participants |
Secondary
Withdrawal
How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason
Time frame: Week 4 and 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 80185 Gel Once Daily Application | Withdrawal | 4 participants |