Clinical trial NCT02387853: Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Official title: Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 117
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.


Eligibility criteria: Inclusion Criteria (all subjects)

* Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.
* Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.
* A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
* PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
* PGA score of at least mild on scalp at SV1, SV2 and V1.
* A serum albumin-corrected calcium below the upper reference limit at SV2.

Inclusion Criteria (for subjects performing HPA axis assessment)

* Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA.
* Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area.
* PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.
* PGA score of at least moderate on scalp at SV1, SV2 and V1.
* Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).

Exclusion Criteria (all subjects):

* A history of hypersensitivity to any component of LEO 90100.
* 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 V1 and during the trial:

  1. etanercept - within 4 weeks prior to V1
  2. adalimumab, infliximab - within 2 months prior to V1
  3. ustekinumab - within 4 months prior to V1
  4. experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1
* Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
* PUVA therapy within 4 weeks prior to V1.
* UVB therapy within 2 weeks prior to V1 or during the trial.

Exclusion Criteria (for subjects performing HPA axis assessment):

* 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.
* Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: From Week -1 to Week 8
measure: Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
timeFrame: 30 minutes after ACTH-challenge at Week 4
measure: Change in Albumin-corrected Serum Calcium From Baseline to Week 4
timeFrame: From baseline to Week 4
measure: Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
timeFrame: From baseline to Week 4
measure: Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
timeFrame: From baseline to Week 4
Secondary outcomes:
measure: Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
timeFrame: 30 and 60 minutes after ACTH-challenge at Week 4
measure: Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
timeFrame: From baseline to Week 4
measure: Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
timeFrame: Week 4
measure: Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
timeFrame: Week 4
measure: Percentage Change in PASI From Baseline to Week 4
timeFrame: From baseline to Week 4
measure: Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
timeFrame: Week 4
measure: Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
timeFrame: Week 4
measure: Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
timeFrame: From baseline to Week 4
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: Santa Rosa
country: United States
facility: Redwood Family Dermatology
state: California
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: New York
country: United States
facility: Greenwich Village Dermatology
state: New York
city: New York
country: United States
facility: Skin Speciality Dermatology
state: New York
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center PA
state: Texas
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
city: Katowice
country: Poland
facility: MULTIKLINIKA SALUTE Sp zo.o.
city: Bucharest
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Tropicale
Study officials:
affiliation: UMC St Radboud
name: M Seyger, MD
role: PRINCIPAL_INVESTIGATOR
References: