Clinical trial NCT01120223: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scalp Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Subjects With Adverse Drug Reactions (ADRs)
timeFrame: Throughout trial, up to 8-weeks
measure: Change in Albumincorrected Serum Calcium From Baseline to Week 4
timeFrame: Baseline and week 4
measure: Change in Albumincorrected Serum Calcium From Baseline to Week 8
timeFrame: Baseline and week 8
measure: Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
timeFrame: Baseline and End of treatment (up to 8 weeks)
measure: Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
timeFrame: Baseline and week 4
measure: Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
timeFrame: Baseline and week 8
measure: Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
timeFrame: Baseline and End of treatment (up to 8 weeks)
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
timeFrame: Baseline and week 4
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
timeFrame: Baseline and week 8
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
timeFrame: Baseline and End of treatment (up to 8 weeks)
Secondary outcomes:
measure: Change in Plasma PTH From Baseline to Week 4
timeFrame: Baseline and week 4
measure: Change in Plasma PTH From Baseline to Week 8
timeFrame: Baseline and week 8
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
timeFrame: Week 2
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4
timeFrame: Week 4
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8
timeFrame: Week 8
measure: 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
timeFrame: End of treatment (up to 8 weeks)
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and week 4
measure: 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
timeFrame: Baseline and week 8
measure: 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.
timeFrame: Baseline and End of treatment (up to 8 weeks)
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2
timeFrame: Week 2
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4
timeFrame: Week 4
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8
timeFrame: Week 8
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment
timeFrame: End of treatment (up to 8 weeks)
measure: Withdrawal
timeFrame: Week 4 and 8
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Clinic Dermatology Research
state: Manitoba
city: Barrie
country: Canada
facility: UltraNova Skincare
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology and Cosmetic Surgery
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital, Division of Dermatology
state: Saskatchewan
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie
city: Airdrie
country: United Kingdom
facility: Monklands Hospital
state: Lanarkshire
city: Burbage
country: United Kingdom
facility: Burbage Surgery
state: Leicestershire
city: Leytonstone
country: United Kingdom
facility: Whipps Cross University Hospital
state: London
city: Salford
country: United Kingdom
facility: Hope Hospital
state: Manchester
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: W. Yorkshire
city: Birmingham
country: United Kingdom
facility: City Hospital
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
Study officials:
affiliation: Royal Gwent Hospital
name: Alexander V Anstey, MD
role: PRINCIPAL_INVESTIGATOR
References: