Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

Conditions

• Chronic Hand Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
• placebo — DRUG
  patient receive placebo

Study Details

Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

Key Dates

Start date

Jul 15, 2019

Status verified

Nov 2024

Primary completion

Nov 9, 2023

Completion

Dec 20, 2023

Study Design

Enrollment

94 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: dupilumab group
  patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
• Placebo Comparator: placebo group
  patient receive placebo

Primary Outcome Measure

severity score mTLSS (modified Total Lesion Symptom Score) [ Time Frame: Week 16 ]