Clinical Trials Logo
  1. Home
  2. Eczema
  3. NCT04949841

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials — DELTA3  

Chronic Hand Eczema Clinical Trial

Official title:
A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

Clinical Trial Summary

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib. Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Clinical Trial Description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial. Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered. Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04949841
Study type Interventional
Source LEO Pharma
Contact
Status Completed
Phase Phase 3
Start date August 23, 2021
Completion date September 18, 2023
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT05545215 - Prospective Real-World Clinical Investigation on Dexyane Med® in Adults With Chronic Hand Eczema
Completed NCT05486117 - Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema Phase 1
Recruiting NCT06004050 - A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema Phase 3
Recruiting NCT05682859 - Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) Phase 4
Recruiting NCT05994976 - Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Completed NCT03683719 - Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema Phase 2
Completed NCT04872101 - Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2) Phase 3
Completed NCT01482663 - Chronic Hand Eczema - Self-management and Prognosis N/A
Completed NCT04871711 - Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema Phase 3
Recruiting NCT05026554 - Characterization of Chronic Hand Eczema
Completed NCT05259722 - A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema Phase 3
Recruiting NCT03861455 - Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids Phase 2
Recruiting NCT05355818 - Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema Phase 3
Completed NCT03246776 - Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan Phase 4
Not yet recruiting NCT06283550 - Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy Phase 2
Completed NCT04378569 - Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema Phase 1/Phase 2