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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01120223
First received: April 9, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Scalp Psoriasis
Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Change in albumin-corrected serum calcium from baseline [ Time Frame: Week 4, Week 8, end of treatment ] [ Designated as safety issue: Yes ]
  • Change in 24-hour urinary calcium excretion from baseline [ Time Frame: Week 4, Week 8, end of treatment ] [ Designated as safety issue: Yes ]
  • Adverse drug reactions (ADRs) [ Time Frame: Throughout trial ] [ Designated as safety issue: Yes ]
  • Change in urinary calcium:creatinine ratio from Baseline [ Time Frame: Week 4, Week 8, end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator's global assessment of disease severity [ Time Frame: Weeks 2, 4, 8 and end of treatment ] [ Designated as safety issue: No ]
  • Total Sign Score (sum of redness, thickness and scaliness scores) [ Time Frame: Weeks 2, 4, 8 and end of treatment ] [ Designated as safety issue: No ]
  • Patient's global assessment of disease severity [ Time Frame: Weeks 2, 4, 8 and end of treatment ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [ Time Frame: Throughout trial ] [ Designated as safety issue: Yes ]
  • Change in plasma PTH from Baseline (SV2) [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: May 2010
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 80185 gel once daily application Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Once daily application

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120223

Locations
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Canada, Manitoba
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
UltraNova Skincare
Barrie, Ontario, Canada, L4M 6L2
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1A8
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 1Z2
The Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, Canada, L4B 1A5
Canada, Saskatchewan
Royal University Hospital, Division of Dermatology
Saskatoon, Saskatchewan, Canada, S7N 0W8
France
CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie
Saint-Etienne, France, 42055
United Kingdom
Monklands Hospital
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
Burbage Surgery
Burbage, Leicestershire, United Kingdom, LE10 2SE
Whipps Cross University Hospital
Leytonstone, London, United Kingdom, E11 1NR
Hope Hospital
Salford, Manchester, United Kingdom, M6 8HD
Harrogate District Hospital
Harrogate, North Yorkshire, United Kingdom, HG2 7SX
Leeds General Infirmary
Leeds, W. Yorkshire, United Kingdom, LS1 3EX
City Hospital
Birmingham, United Kingdom, B18 7QH
Royal Gwent Hospital
Newport, United Kingdom, NP20 2UB
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Alexander V Anstey, MD Royal Gwent Hospital
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01120223     History of Changes
Other Study ID Numbers: MBL 0412 INT, 2008-005456-24
Study First Received: April 9, 2010
Last Updated: November 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 25, 2014