Status and phase
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Study type
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About
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis. LEO 80185 topical suspension has marketing approval in many countries under the brand names Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
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):
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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