Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week
      trial in adolescent subjects with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria (all subjects)

          -  Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.

          -  Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.

          -  A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.

          -  PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.

          -  PGA score of at least mild on scalp at SV1, SV2 and V1.

          -  A serum albumin-corrected calcium below the upper reference limit at SV2.

        Inclusion Criteria (for subjects performing HPA axis assessment)

          -  Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA.

          -  Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area.

          -  PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.

          -  PGA score of at least moderate on scalp at SV1, SV2 and V1.

          -  Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before
             ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH
             challenge).

        Exclusion Criteria (all subjects):

          -  A history of hypersensitivity to any component of LEO 90100.

          -  Systemic treatment with biological therapies (marketed or not marketed), with a
             possible effect on scalp and/or body psoriasis within the following time period prior
             to V1 and during the trial:

               1. etanercept - within 4 weeks prior to V1

               2. adalimumab, infliximab - within 2 months prior to V1

               3. ustekinumab - within 4 months prior to V1

               4. experimental products - within 4 weeks/5 half-lives (whichever is longer) prior
                  to V1

          -  Systemic treatment with therapies other than biologicals, with a possible effect on
             scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within
             4 weeks prior to V1 or during the trial.

          -  PUVA therapy within 4 weeks prior to V1.

          -  UVB therapy within 2 weeks prior to V1 or during the trial.

        Exclusion Criteria (for subjects performing HPA axis assessment):

          -  A history of serious allergy, allergic asthma or serious allergic skin rash.

          -  Known or suspected hypersensitivity to any component of CORTROSYN® (including
             ACTH/cosyntropin/tetracosactide)

          -  Systemic treatment with corticosteroids (including inhaled and nasal steroids) within
             12 weeks prior to SV2 or during the trial.

          -  Oestrogen therapy (including contraceptives) or any other medication known to affect
             cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.