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New eczema gel shows promise in early trial
NCT ID NCT04992546
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new topical gel called PRN473 (SAR444727) in 39 adults with mild to moderate atopic dermatitis (eczema). Each participant had two similar patches of eczema treated: one with the study gel and one with a placebo gel, without knowing which was which. The main goals were to check safety and how the body processes the drug. The study lasted about 13 weeks and is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRN473 (SAR444727) topical gel
- What this could lead to
- If successful, this could lead to a new topical treatment option for mild to moderate eczema that is applied directly to the skin.
- What could go wrong
- This was a small, early-phase study (Phase 2a) with only 39 participants. The results may not apply to everyone, and the treatment may not prove effective in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
39 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Dec 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and female adults 18 to 70 years of age (inclusive) at the time of informed consent. * Diagnosed with mild to moderate AD. * History of AD for at least 6 months as determined by the Investigator through patient interview. * Stable disease for the 4 weeks prior to the screening visit with no significant flares in AD as determined by the Investigator. * Validated Investigator Global Assessment-atopic dermatitis (vIGA-AD) score of Moderate or Mild at Screening. The vIGA-AD was evaluated for the entire body except scalp, palms, soles and genitals. * HadAD involvement (excluding scalp, palms, soles and genitals) of at least 1.0% BSA and no more than 14.0% BSA. * Had at least two target lesions 100 cm2 or greater with a difference no greater than 1 point in lesion TSS and at least 5 cm apart located on the trunk (excluding genitals) or upper extremities (excluding palms). * If female, patients with child-bearing potential must have a negative pregnancy test, and agree to practice true abstinence or agree to use highly effective contraception. * If male, agree to use a male condom and highly effective contraception with female partners of child-bearing potential. * In good health as judged by the Investigator. Exclusion Criteria: * Patients who had failed 2 or more prior systemic treatments for AD. * Patients who had received a live or attenuated vaccine in the last 12 weeks or intend to receive a live or attenuated vaccine during the study. * Patients who cannot discontinue prohibited medications and treatments prior to the Baseline visit and during the study. * Has unstable AD, based on the judgement of the Investigator, or any consistent requirement for high potency topical steroids to manage AD signs or symptoms. * Patients who had significant active systemic or localized bacterial, viral, fungal, and helminth infection in the last 30 days. * Patients unwilling to refrain from prolonged sun exposure or use of a tanning bed or other artificial light emitting devices for 4 weeks prior to Baseline and during the study. * Patients with other skin conditions that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. * Patients with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome. * Previous used of a BTK inhibitor. * Women who were pregnant, wishing to become pregnant during the study, or were breastfeeding. * Patients were undergoing allergy (eg, food allergy testing or skin prick testing), patch testing, or food challenges, or plan to do so during the study. * Patients who had undergone major surgery within 4 weeks prior to Day 1 or patients who had a major surgery planned during the study. * Regular use of drugs of abuse or regular alcohol consumption within 6 months prior to the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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California Allergy & Asthma Medical Group-Site Number:8400008
Los Angeles, California, 90025, United States
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Center for Clinical Studies, LTD. LLP-Site Number:8400014
Houston, Texas, 77004, United States
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Clinical Research Trials of Florida, Inc-Site Number:8400013
Tampa, Florida, 33607, United States
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Collaborative Neuroscience Research-Site Number:8400004
Long Beach, California, 90806, United States
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Florida International Research Center-Site Number:8400017
Miami, Florida, 33173, United States
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Investigational Site Number :1240002
Québec, G1G 3Y8, Canada
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Investigational Site Number :1240007
London, Ontario, N6H 5L5, Canada
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Investigational Site Number :1240008
Hamilton, Ontario, L8L 3C3, Canada
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J&S Studies-Site Number:8400015
Bryan, Texas, 77802, United States
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Lenus Research & Medical Group-Site Number:8400006
Sweetwater, Florida, 33172, United States
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Progressive Clinical Research-Site Number:8400002
San Antonio, Texas, 78213, United States
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Remington Davis Inc-Site Number:8400012
Columbus, Ohio, 43215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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