An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 80185 gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial
      in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
    

Eligibility criteria:

        Inclusion Criteria (all subjects):

          -  Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)

          -  At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs)
             psoriasis which is:

               -  of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions
                  of the face and sensitive areas. Sensitive areas include armpits, groin, under
                  the breasts and in other skin folds around the genitals and buttocks), and

               -  of at least moderate severity according to the investigator's global assessment
                  of disease severity on the body.

          -  A serum albumin-corrected calcium level below the upper reference limit at SV2

        Inclusion Criteria (for subjects performing HPA axis assessments):

          -  At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:

               -  more than or equal to 20% of the scalp area, and

               -  of at least moderate severity according to the investigator's global assessment
                  of disease severity on the scalp.

          -  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.

        Inclusion Criteria (for subjects not performing HPA axis assessments):

          -  At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:

               -  more than or equal to 10% of the scalp area, and

               -  of at least moderate severity according to the investigator's global assessment
                  of disease severity on the scalp.

        Exclusion Criteria (all subjects):

          -  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 Visit 1 and during the trial:

               -  etanercept - within 4 weeks prior to Visit 1

               -  adalimumab, infliximab - within 2 months prior to Visit 1

               -  ustekinumab - within 4 months prior to Visit 1

               -  experimental products - 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 and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks
             prior to Visit 1 (Day 0) or during the trial.

          -  UVB therapy within 2 weeks prior to Visit 1 or during the trial.

          -  Any topical treatment on the scalp and body (except for emollients and non-steroid
             medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.

          -  Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics,
             diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.

          -  Planned initiation of, or changes to, concomitant medication that could affect
             psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.

          -  Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

          -  Subjects with any of the following conditions present on the treatment areas on scalp
             and/or body: viral (e.g., herpes or varicella) lesions of the skin, fungal and
             bacterial skin infections, parasitic infections, skin manifestations in relation to
             syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae
             atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.

          -  Other inflammatory skin diseases that may confound the evaluation of scalp and/or body
             psoriasis.

          -  Planned excessive exposure to sun during the trial that may affect scalp and/or body
             psoriasis.

          -  Known or suspected severe renal insufficiency or severe hepatic disorders.

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

          -  Any clinically significant abnormality following review of screening laboratory tests
             (blood and urine samples), physical examination or blood pressure/heart rate
             measurement performed at SV2.

          -  Current participation in any other interventional clinical trial.

          -  Previously enrolled in this trial.

          -  Subjects who have received treatment with any non-marketed drug substance (i.e., an
             agent which has not yet been made available for clinical use following registration)
             within a month prior to SV1 or longer, if the class of substance required a longer
             wash-out as defined above (e.g., biological treatments).

          -  Subjects or parent(s) or legal guardian known or suspected of being unlikely to comply
             with the Clinical Trial Protocol (e.g., alcoholism, drug dependency or psychotic
             state).

          -  Females who are pregnant, or of child-bearing potential and wishing to become pregnant
             during the trial, or who are breast-feeding.

          -  Females of child-bearing potential with positive pregnancy test at SV2.

          -  Subject (or their partner) not using an adequate method of contraception according to
             national requirements.

        Exclusion Criteria (for subjects performing HPA axis assessments)

          -  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.

          -  Topical treatment with corticosteroids within 2 weeks prior to SV2 or during the
             trial.

          -  Oestrogen therapy (including contraceptives) or any other medication known to affect
             cortisol levels levels or HPA axis integrity within 4 weeks prior to SV2 or during the
             trial.

          -  Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior
             to SV2 or during the trial.

          -  Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole,
             metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole 2
             weeks prior to SV2.

          -  Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.

          -  Antidepressive medications within 4 weeks prior to SV2 or during the trial.

          -  Known or suspected endocrine disorder that may affect the results of the ACTH
             challenge test.

          -  Clinical signs or symptoms of Cushing's disease or Addison's disease.

          -  Subjects with diabetes mellitus.

          -  Known or suspected cardiac condition.

          -  Not following nocturnal sleep patterns.