NCT02111499

Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test

A Randomized, Controlled, Observer-blind Psoriasis Plaque Test to Investigate the Anti-psoriatic Efficacy, Tolerability and Safety (Skin Atrophy) of LAS41004 Formulations in Patients With Mild to Moderate Plaque Psoriasis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical investigation of anti-psoriatic efficacy and atrophy

Detailed description

In this trial three concentrations of bexarotene in combination with a fixed concentration of betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated regarding their efficacy, tolerability and safety in patients with mild to moderate plaque psoriasis and will be compared with the vehicle and an active comparator. Since a side effect of the application of corticosteroids is skin atrophy, additionally three non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with the active reference product, one of the fixed combinations and the vehicle. Skin atrophy will be investigated by visual assessment and ultrasound at these test areas

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	LAS41004-IMP1	daily topical application
DRUG	LAS41004 IMP2	daily topical application
DRUG	LAS41004 IMP3	daily topical application
DRUG	LAS41004 IMP4	daily topical application
DRUG	LAS41004 IMP6	daily topical application
DRUG	LAS41004 IMP5	once daily, topical

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-04-11
• Last updated: 2014-06-09

Locations

1 site across 1 country: Germany