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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 baseline to day 56
Awards & highlights
Study Summary
This trial will investigate if ASN008, a topical treatment, can help reduce itch in people with eczema. Participants will use ASN008 or placebo cream to see which works best.
Who is the study for?
Adults over 18 with mild to moderate atopic dermatitis (eczema) for at least a year, who haven't had severe flare-ups in the past month. They should have a certain level of itchiness and eczema covering no more than 20% of their body. Participants must not be pregnant or planning pregnancy and agree to follow trial procedures.Check my eligibility
What is being tested?
The trial is testing ASN008's ability to relieve itching from eczema by comparing three different doses against a placebo. Participants will apply either ASN008 or a non-medicated cream twice daily for four weeks while researchers monitor which dose is most effective and safe.See study design
What are the potential side effects?
Potential side effects are not specified, but generally could include skin irritation, redness, or allergic reactions related to the application of topical treatments like ASN008.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Peak Pruritus NRS
Secondary outcome measures
Mean change from Baseline in Eczema Area and Severity Index (EASI) score
Mean change from Baseline in the Patient-Oriented Eczema Measure (POEM)
Mean change from Baseline in total body surface area (BSA)
+1 moreOther outcome measures
Incidence of TEAEs leading to treatment discontinuation
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by Peak Plasma Concentration (Cmax)
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by area under the plasma concentration versus time curve (AUC)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ASN008 5%Experimental Treatment1 Intervention
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Group II: ASN008 2.5%Experimental Treatment1 Intervention
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Group III: ASN008 1.25%Experimental Treatment1 Intervention
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Group IV: ASN008 Matching VehiclePlacebo Group1 Intervention
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASN008
2023
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
TrialSparkLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had mild to moderate Alzheimer's disease for at least 12 months and have not had any significant worsening of symptoms for at least 4 weeks before the screening.Your skin condition is rated as moderate to severe by the study doctor at the beginning of the trial.You have used certain medications for eczema within 2 weeks before the start of the study.You have used certain types of light therapy or excimer laser treatment within the last 4 weeks before the start of the study.You have taken certain medications that could affect your atopic dermatitis in the last 6 weeks.Less than 20% of your skin is affected by atopic dermatitis on the first day of the trial.You have severe itching with a score of 7 or more on a scale from 0 to 10.Your body mass index (BMI) is less than or equal to 40.You are allergic to ASN008 or any of its ingredients.You currently have an infection that needs treatment, including infected skin conditions.You have used doxepin, hydroxyzine, or diphenhydramine within the week before the study starts.You have taken oral antibiotics within the past 2 weeks, or used antibiotic creams within the past week before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: ASN008 2.5%
- Group 2: ASN008 1.25%
- Group 3: ASN008 5%
- Group 4: ASN008 Matching Vehicle
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is ASN008 1.25% a secure option for medical consumers?
"Our team has assigned ASN008 1.25% a score of 2 on the safety scale due to its status as a Phase 2 trial, in which some data exists regarding safety but none that can be used to confirm efficacy."
Answered by AI
Are there any current opportunities to take part in this experiment?
"Per the details listed on clinicaltrials.gov, this study is currently recruiting research subjects. The trial was first posted on May 3rd 2023 and its information was most recently updated a little over a week later, on May 12th of the same year."
Answered by AI
What is the current capacity for participant enrollment in this clinical trial?
"Affirmative. Clinicaltrials.gov reports that this research endeavor, which was first posted on May 3rd 2023, is actively recruiting individuals to participate. In total, 120 participants need to be drawn from 13 separate clinical trial sites."
Answered by AI
How many facilities is this experiment managed across?
"This medical trial is running out of 15 different sites, including TrialSpark Investigative Site 0118 in Hot Springs, Arkansas, TrialSpark Investigative Site 0101 in Los Angeles, California and TrialSpark Investigative Site 0103 in Miami Lakes Florida."
Answered by AI
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