Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Study Overview
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Brief Summary
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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

Official Title
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Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 80185 gel once daily application<br> | Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)<br>* Once daily application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Throughout trial, up to 8-weeks | 
| Change in Albumincorrected Serum Calcium From Baseline to Week 4 | Change in albumincorrected serum calcium from Baseline to week 4 | Baseline and week 4 | 
| Change in Albumincorrected Serum Calcium From Baseline to Week 8 | Change in albumincorrected serum calcium from Baseline to week 8 | Baseline and week 8 | 
| Change in Albumincorrected Serum Calcium From Baseline to End of Treatment | Change in albumincorrected serum calcium 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 Week 4 | 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 8 | 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 End of Treatment | Change in 24-hour urinary calcium excretion from Baseline to end of treatment | Baseline and End of treatment (up to 8 weeks) | 
| Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 | 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 8 | Change in urinary calcium:creatinine ratio from Baseline to week 8 | Baseline and week 8 | 
| Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment | Change in urinary calcium:creatinine ratio from Baseline to end of treatment | Baseline and End of treatment (up to 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma PTH From Baseline to Week 4 | Change in plasma PTH (parathyroid hormone) from Baseline to week 4 | Baseline and week 4 | 
| Change in Plasma PTH From Baseline to Week 8 | Change in plasma PTH (parathyroid hormone) from Baseline to week 8 | Baseline and 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 | 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. | Week 2 | 
| 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 | 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 | 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 | 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 | 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 | End of treatment (up to 8 weeks) | 
| 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). | Baseline and week 2 | 
| 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. | Baseline and week 4 | 
| 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). | Baseline and week 8 | 
| 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). | Baseline and End of treatment (up to 8 weeks) | 
| 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. | Week 2 | 
| 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. | Week 4 | 
| 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. | Week 8 | 
| 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. | End of treatment (up to 8 weeks) | 
| 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 | Week 4 and 8 |