NCT01545284

Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .

Detailed description

Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, will be increased in the first 4 weeks to a maximum of 30 mg/day.

Conditions

• Chronic Hand Dermatitis

Interventions

Type	Name	Description
DRUG	Acitretin	All patients will receive open-label single oral acitretin 10 mg capsule once daily as a starting dose. If well tolerated, the dose will be increased in the first 4 weeks to a maximum of 30mg/day. Patients will be instructed to take the treatment as a single oral dose with a meal.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-03-06
• Last updated: 2014-07-24

Locations

2 sites across 1 country: Canada