Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam 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.