You last viewed on May 27, 2026
Status and phase
Conditions
Treatments
Start date
May 03, 2023 • 3 years ago
End date
Nov 27, 2023 • 2 years ago
Results posted
ViewDec 27, 2024 • 1 year and 5 months ago
Today
May 27, 2026
Lead Sponsor
About
The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are:
Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.
Full description
All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial.
Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28.
Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET).
The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period.
A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
Active infection requiring treatment, including skin infections (including clinically infected AD).
History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments.
Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results.
Use of any of the following treatments within the indicated washout period before Day 1:
Known hypersensitivity to ASN008 or its excipients.
Primary purpose
Allocation
Interventional model
Masking
144 participants in 4 patient groups, including a placebo group
All locations
TrialSpark Investigative Site 0121
Houston, Texas, United States, 77056
TrialSpark Investigative Site 0107
Auburn Hills, Michigan, United States, 48326
TrialSpark Investigative Site 0105
Wilmington, North Carolina, United States, 28405
TrialSpark Investigative Site 0109
Indianapolis, Indiana, United States, 46250
TrialSpark Investigative Site 0102
Saint Joseph, Missouri, United States, 54506
TrialSpark Investigative Site 0103
Miami Lakes, Florida, United States, 33014
TrialSpark Investigative Site 0112
Louisville, Kentucky, United States, 40241
TrialSpark Investigative Site 0114
San Antonio, Texas, United States, 78213
TrialSpark Investigative Site 0108
Baton Rouge, Louisiana, United States, 70808
TrialSpark Investigative Site 0115
Kew Gardens, New York, United States, 11415
TrialSpark Investigative Site 0106
Scottsdale, Arizona, United States, 85255
TrialSpark Investigative Site 0118
Hot Springs, Arkansas, United States, 71913
TrialSpark Investigative Site 0113
Fremont, California, United States, 94538
TrialSpark Investigative Site 0123
Beverly Hills, California, United States, 90212
TrialSpark Investigative Site 0127
Oklahoma City, Oklahoma, United States, 73170
TrialSpark Investigative Site 0126
San Antonio, Texas, United States, 78229
TrialSpark Investigative Site 0129
Miramar, Florida, United States, 33027
TrialSpark Investigative Site 0125
Mason, Ohio, United States, 45040
TrialSpark Investigative Site 0122
Philadelphia, Pennsylvania, United States, 19103
TrialSpark Investigative Site 0117
Richmond, Virginia, United States, 23226
TrialSpark Investigative Site 0130
Pflugerville, Texas, United States, 78660
TrialSpark Investigative Site 0131
Clarksville, Indiana, United States, 47129
TrialSpark Investigative Site 0124
Monroe, Louisiana, United States, 71201
TrialSpark Investigative Site 0128
Spokane, Washington, United States, 99202
TrialSpark Investigative Site 0101
Los Angeles, California, United States, 90057
TrialSpark Investigative Site 0119
New York, New York, United States, 10075
TrialSpark Investigative Site 0110
Springville, Utah, United States, 84663
Central trial contact
TrialSpark
Data sourced from clinicaltrials.gov
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