Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

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