Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-28

Brief Summary

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

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LEO 90100

Group Type EXPERIMENTAL

LEO 90100

Intervention Type DRUG

Interventions

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LEO 90100

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.

* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No