New lotion could ease rare skin disorder
NCT ID NCT05521438
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a lotion called QRX003 in 30 people with Netherton Syndrome, a rare genetic skin condition. The lotion contains a drug that blocks certain enzymes thought to cause skin problems. Researchers are checking if it reduces redness, scaling, and itching compared to a placebo lotion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QRX003 lotion (a serine protease inhibitor)
- What this could lead to
- If it works, this could provide a topical treatment to control skin symptoms like redness, scaling, and itching in Netherton Syndrome.
- What could go wrong
- This is an early-to-mid stage trial with only 30 people, so results may not apply to everyone. The lotion may cause skin reactions or not work better than a placebo.
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
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2022
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
14 years and older
- 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: * 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. 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 Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females * 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 systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline. * Subject has used systemic biologic therapy for NS. * 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.
Contacts and locations
Locations
-
Site #1
San Diego, California, 92123, United States
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Site #2
San Antonio, Texas, 72218, United States
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Site #3
Charleston, South Carolina, 29425, United States
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Site #4
Indianapolis, Indiana, 46250, United States
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Site #5
Quincy, Massachusetts, 02169, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an eczema drug calm a rare genetic skin disease?
- Can a skin lotion tame the symptoms of a rare genetic disease?
- Can a lotion calm the severe skin symptoms of netherton syndrome?
- 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