Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
Intervention description: Topical suspension applied once daily for up to 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
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 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
      LEO 80185 topical suspension has marketing approval in many countries under the brand names
      Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in
      adults. No studies have been performed in subjects younger than 18 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent given by parent(s) or legal guardian following their receipt
             of verbal and written information about the study

          -  Subjects will receive verbal and written information and will provide written assent
             to the study

          -  Any race or ethnicity

          -  Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with
             psoriasis vulgaris on trunk and/or limbs

          -  At Screening Visit 2 and Visit 1 a clinical diagnosis of scalp psoriasis which is:

               -  amenable to topical treatment with a maximum of 60 g of study medication per
                  week, and

               -  of an extent of more than or equal to 20% of the scalp area

               -  of at least moderate severity according to the investigator's global assessment

          -  Subjects with a normal HPA axis function at SV2 including serum cortisol concentration
             above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl
             30 minutes after ACTH challenge

          -  A serum albumin-corrected calcium below the upper reference limit at Screening Visit 2

          -  Females of child-bearing potential must have a negative urine pregnancy test result
             and must agree to use a highly effective method of contraception (abstinence is an
             acceptable method).

        Exclusion Criteria (summary):

          -  A history of serious allergy, allergic asthma or serious allergic skin rash

          -  Known or suspected hypersensitivity to any medication (including
             ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 topical
             suspension or CORTROSYN

          -  Systemic treatment with corticosteroids (including inhaled and nasal steroids) within
             12 weeks prior to Screening Visit 2 or during the study

          -  Topical treatment with corticosteroids within 2 weeks prior to Screening Visit 2 or
             during the study

          -  Oestrogen therapy (including contraceptives) or any other medication known to affect
             cortisol levels or HPA axis integrity within 4 weeks prior to Screening Visit 2 or
             during the study

          -  Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin)or cytochrome P450
             inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to
             Screening Visit 2 or during the study. Topical ketoconazole 2 weeks prior to Screening
             Visit 2

          -  Hypoglycemic sulfonamides or Antidepressive medications within 4 weeks prior to
             Screening Visit 2 or during the study

          -  Known or suspected endocrine disorder that may affect the results of the ACTH
             challenge test

          -  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 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., retinoids, immunosuppressants, PUVA) within 4 weeks prior to
             Visit 1 (Day 0) 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

          -  Other inflammatory skin diseases that may confound the evaluation of scalp psoriasis

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia