Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Intervention description: Once daily application
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

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