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