NCT03025282

Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This was an exploratory, single-center, investigator blinded, randomized, controlled, intra-individual study, involving participants with psoriasis vulgaris. The objective was to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.

Detailed description

Study drugs would be applied in each participant once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below: * on 2 mini-zones pretreated by a keratolytic product, would be tested: * CD10367 3% solution * CD10367 solution placebo * on 4 mini-zones non-pretreated, would be tested: * CD10367 3% solution * CD10367 1% solution * CD10367 solution placebo * Betneval 0.1% ointment

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	CD10367 3% Solution - Non-desquamated zone	Once daily application for 3 weeks
DRUG	CD10367 1% Solution - Non-desquamated zone	Once daily application for 3 weeks
DRUG	CD10367 solution placebo - Non-desquamated zone	Once daily application for 3 weeks
DRUG	Betneval ointment - Non-desquamated zone	Once daily application for 3 weeks
DRUG	CD10367 3% Solution - Desquamated zone	Once daily application for 3 weeks
DRUG	CD10367 solution placebo - Desquamated zone	Once daily application for 3 weeks

Timeline

• Start date: 2016-11-03
• Primary completion: 2017-03-24
• Completion: 2017-03-24
• First posted: 2017-01-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: France