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

Exclusion Criteria

• •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.
• •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.