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ASN008 2.5% for Atopic Dermatitis

TrialSpark Investigative Site 0108, Baton Rouge, LA
Atopic Dermatitis+1 More ConditionsASN008 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Atopic Dermatitis
  • Itching

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline to Day 56

Baseline and Week 4
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)
Baseline to Day 56
Incidence of TEAEs leading to treatment discontinuation
Number of Investigational Product (IP)-related TEAEs
Number of Treatment Emergent Adverse Events (TEAEs)
Baseline to Week 4
Daily Peak Pruritus NRS
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)
Pruritus response of ASN008 topical gel on AD assessed by Daily Peak Pruritus NRS

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
AAA Group (Aim 3A)
1
Abemaciclib
1
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Trial Design

4 Treatment Groups

ASN008 2.5%
1 of 4
ASN008 5%
1 of 4
ASN008 1.25%
1 of 4
ASN008 Matching Vehicle
1 of 4

Experimental Treatment

Non-Treatment Group

120 Total Participants · 4 Treatment Groups

Primary Treatment: ASN008 2.5% · Has Placebo Group · Phase 2

ASN008 2.5%
Drug
Experimental Group · 1 Intervention: ASN008 · Intervention Types: Drug
ASN008 5%
Drug
Experimental Group · 1 Intervention: ASN008 · Intervention Types: Drug
ASN008 1.25%
Drug
Experimental Group · 1 Intervention: ASN008 · Intervention Types: Drug
ASN008 Matching Vehicle
Other
PlaceboComparator Group · 1 Intervention: ASN008 Matching Vehicle · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 56

Who is running the clinical trial?

TrialSparkLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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