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

• Status: Completed
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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.