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Retinoid
Delgocitinib Cream and Alitretinoin for Chronic Hand Dermatitis
Phase 3
Waitlist Available
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests two treatments for adults with severe chronic hand eczema who haven't improved with standard treatments. Participants will use either a special cream or take capsules to see which works better in reducing symptoms and improving quality of life.
Eligible Conditions
- Eczema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in HECSI score from baseline to Week 12
Secondary study objectives
AUC of HECSI-90 from baseline up to Week 24
AUC of change from baseline in DLQI score up to Week 24
Change in HECSI score from baseline to Week 24
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Delgocitinib cream 20 mg/gExperimental Treatment1 Intervention
Twice-daily topical application for up to 24 weeks
Group II: Alitretinoin capsules 30 mg per capsuleActive Control1 Intervention
1 capsule per day for up to 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delgocitinib
2021
Completed Phase 3
~1330
Find a Location
Who is running the clinical trial?
LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,150 Total Patients Enrolled
45 Trials studying Eczema
19,739 Patients Enrolled for Eczema
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
9,798 Total Patients Enrolled
21 Trials studying Eczema
4,689 Patients Enrolled for Eczema
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but I would need more context or information to accurately summarize this criterion in plain language. Can you please provide more details or clarify your request?You follow regular skin care without using any special medications and avoid things that may irritate or cause an allergic reaction to your skin.You currently have a skin condition on your hands, like a fungal infection called tinea manuum.You have a serious infection on your hands.You currently have psoriasis anywhere on your body.You have used antibiotics by mouth or on your skin in the past two weeks.You have used tanning beds, phototherapy, or bleach baths on your hands in the last 28 days before the study starts.You are not able to take alitretinoin.You have a positive test for hepatitis B or hepatitis C.You have a known immune system disorder or have tested positive for HIV, or are taking medications for HIV.You have been diagnosed with chronic hand eczema that has lasted for more than 3 months or has come back two or more times in the last year.You have taken Janus kinase (JAK) inhibitors, like delgocitinib/LEO 124249, in the past.You have rough, scaly skin on your hands along with a history of psoriasis anywhere on your body.Your skin condition is graded as moderate to severe according to a specific scale called IGA-CHE.You have a skin condition that needs ongoing treatment, except on your hands and feet.You have received certain biological treatments in the past few months that may affect your immune system.You have used alitretinoin before or been in a study involving alitretinoin or delgocitinib.You have had hand eczema for more than 3 months, or it has come back two or more times in the last year.Your skin condition is classified as moderate to severe based on a specific scoring system.You have recently tried using topical corticosteroids and they did not work well for you, or it's not safe for you to use them because of side effects or other risks.You have used certain skin treatments on your hands within 14 days before the start of the study.You have taken certain medications that affect the immune system within the last 28 days.You have tried using topical corticosteroids and they did not work well for you, or they are not safe for you to use due to side effects or other risks.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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