Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

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

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.