Can a lotion calm the severe skin symptoms of netherton syndrome?
NCT ID NCT05789056
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether QRX003 lotion, applied to the skin, can safely reduce the severity of Netherton syndrome, a rare genetic condition causing red, scaly skin and intense itching. Researchers will enroll about 20 people aged 14 and older who have the condition. Participants will use the lotion alongside their usual care, and the study will measure changes in skin appearance, itch scores, and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QRX003, a topical lotion containing a serine protease inhibitor
- What this could lead to
- If it works, QRX003 could offer a new way to control Netherton syndrome symptoms, reducing itching and skin involvement beyond standard care.
- What could go wrong
- This is a small, early-to-mid-stage trial with only 20 participants, so results may not apply broadly. The lotion may cause local skin reactions or fail to improve symptoms significantly.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Subject is a male or non-pregnant female at least 14 years of age. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline. * Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation. * Subject has NS lesions in the Treatment Area (i.e., arms or lower legs). * Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation. * Subject is on a stable treatment regimen including systemic therapy for NS prior to baseline that is expected to remain stable for the duration of the study Exclusion Criteria: * Subject is pregnant, lactating, or is planning to become pregnant during the study. * Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy. * Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area. * Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled. * Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline. * Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis. * Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline. * Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline. * Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline. * Subject is currently enrolled in an investigational drug, biologic, or device study. * Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Site #1
RECRUITINGSan Diego, California, 92123, United States
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Site #2
NOT_YET_RECRUITINGSan Antonio, Texas, 72218, United States
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Site #4
RECRUITINGIndianapolis, Indiana, 46250, United States
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Site #5
RECRUITINGQuincy, Massachusetts, 02169, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New lotion shows promise for rare skin disorder
- Experimental drug for rare skin disease fails to reach goal
- Scientists hunt for clues to ichthyosis in skin and blood
- Could arthritis drug humira ease rare skin disease?
- Microbiome study seeks clues in rare skin condition