NCT03669757

Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis

A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	LEO 134310	Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
DRUG	LEO 134310	Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
DRUG	LEO 134310	Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
DRUG	LEO 134310	Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
DRUG	LEO 134310 vehicle	Active substance: none
DRUG	0.1% betamethasone valerate ointment (class III steroid)	Active substance: betamethasone valerate

Timeline

• Start date: 2018-09-27
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-09-13
• Last updated: 2024-10-26

Locations

2 sites across 1 country: Germany