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

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kirk Barber Research
  • Winnipeg Clinic Dermatology Research
  • UltraNova Skincare
  • The Guenther Dermatology Research Centre
  • Lynderm Research Inc.
  • SKiN Centre for Dermatology
  • The Centre for Dermatology and Cosmetic Surgery
  • Royal University Hospital, Division of Dermatology
  • CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie
  • Monklands Hospital
  • Burbage Surgery
  • Whipps Cross University Hospital
  • Hope Hospital
  • Harrogate District Hospital
  • Leeds General Infirmary
  • City Hospital
  • Royal Gwent Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEO 80185 gel once daily application

Arm Description

Outcomes

Primary Outcome Measures

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
Change in Albumincorrected Serum Calcium From Baseline to Week 4
Change in albumincorrected serum calcium from Baseline to week 4
Change in Albumincorrected Serum Calcium From Baseline to Week 8
Change in albumincorrected serum calcium from Baseline to week 8
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
Change in albumincorrected serum calcium from Baseline to end of treatment
Change in 24-hour Urinary Calcium Excretion From Baseline to 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
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
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Change in urinary calcium:creatinine ratio from Baseline to week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to 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
Change in urinary calcium:creatinine ratio from Baseline to end of treatment

Secondary Outcome Measures

Change in Plasma PTH From Baseline to Week 4
Change in plasma PTH (parathyroid hormone) from Baseline to week 4
Change in Plasma PTH From Baseline to 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
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
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
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
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
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
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
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.
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).
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.
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.
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.
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.
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

Full Information

First Posted
April 9, 2010
Last Updated
March 25, 2015
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01120223
Brief Title
Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Official Title
Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 80185 gel once daily application
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Intervention Description
Once daily application
Primary Outcome Measure Information:
Title
Percentage of Subjects With Adverse Drug Reactions (ADRs)
Description
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
Title
Change in Albumincorrected Serum Calcium From Baseline to Week 4
Description
Change in albumincorrected serum calcium from Baseline to week 4
Time Frame
Baseline and week 4
Title
Change in Albumincorrected Serum Calcium From Baseline to Week 8
Description
Change in albumincorrected serum calcium from Baseline to week 8
Time Frame
Baseline and week 8
Title
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
Description
Change in albumincorrected serum calcium from Baseline to end of treatment
Time Frame
Baseline and End of treatment (up to 8 weeks)
Title
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Description
Change in 24-hour urinary calcium excretion from Baseline to week 4
Time Frame
Baseline and week 4
Title
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Description
Change in 24-hour urinary calcium excretion from Baseline to week 8
Time Frame
Baseline and week 8
Title
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Description
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Time Frame
Baseline and End of treatment (up to 8 weeks)
Title
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Description
Change in urinary calcium:creatinine ratio from Baseline to week 4
Time Frame
Baseline and week 4
Title
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Description
Change in urinary calcium:creatinine ratio from Baseline to week 8
Time Frame
Baseline and week 8
Title
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
Description
Change in urinary calcium:creatinine ratio from Baseline to end of treatment
Time Frame
Baseline and End of treatment (up to 8 weeks)
Secondary Outcome Measure Information:
Title
Change in Plasma PTH From Baseline to Week 4
Description
Change in plasma PTH (parathyroid hormone) from Baseline to week 4
Time Frame
Baseline and week 4
Title
Change in Plasma PTH From Baseline to Week 8
Description
Change in plasma PTH (parathyroid hormone) from Baseline to week 8
Time Frame
Baseline and week 8
Title
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
Description
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
Title
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Description
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
Title
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8
Description
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
Title
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
Description
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)
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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.
Description
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)
Title
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2
Description
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
Title
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4
Description
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
Title
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8
Description
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
Title
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment
Description
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)
Title
Withdrawal
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V Anstey, MD
Organizational Affiliation
Royal Gwent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Winnipeg Clinic Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
UltraNova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 1Z2
Country
Canada
Facility Name
The Centre for Dermatology and Cosmetic Surgery
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Royal University Hospital, Division of Dermatology
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Monklands Hospital
City
Airdrie
State/Province
Lanarkshire
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Burbage Surgery
City
Burbage
State/Province
Leicestershire
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
W. Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
City Hospital
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom

12. IPD Sharing Statement

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

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