Trial Search Results
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
Stanford is currently not accepting patients for this trial.
- Drug: LEO 90100
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
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
- 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
- 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.
Ages Eligible for Study
12 Years - 17 Years
Genders Eligible for Study