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

Completed · Phase 2

Conditions studied: Scalp Psoriasis

In brief

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.

Key facts

Study ID: NCT01083758
Run by: LEO Pharma
People needed: 31
Starts: 2010-04-01
Expected to finish: 2012-10-01
Last updated by the study team: 2025-03-11

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Rady Children's Hospital San Diego — San Diego, California, United States
Leavitt Medical Associates of Florida, Inc. — Jacksonville, Florida, United States
Leavitt Medical Associates of Florida, Inc. — Ormond Beach, Florida, United States
Peachtree Dermatology Associates, PC — Atlanta, Georgia, United States
Deaconess Clinic — Evansville, Indiana, United States
Skin Specialists, PC — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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