Can dupixent calm mysterious skin flares?
NCT ID NCT06012448
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested the drug dupilumab (Dupixent) in 10 people with a chronic skin condition called dermal hypersensitivity reaction. Participants received injections of dupilumab every two weeks for 24 weeks. Researchers looked at changes in immune cells in the skin and how much body surface area was affected. The goal was to learn if dupilumab is safe and could help treat this condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If it works, this could point toward a treatment for chronic dermal hypersensitivity reaction, a skin condition with no standard therapy.
- What could go wrong
- This is a very small, early-phase study with only 10 participants, so results may not apply to everyone. The drug may not improve symptoms or could cause side effects like injection reactions or infections.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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10 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 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: * Established diagnosis of chronic idiopathic DHR as defined by presence of clinical and histopathologic features of DHR for at least 6 weeks without an underlying cause or associated trigger * Moderate-to-severe DHR as defined by greater or equal 5% total body-surface-area (TBSA) involvement and IGA of greater or equal to 3. * Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. * Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol. Exclusion Criteria: * Subjects meeting 1 or more of the following criteria at screening or baseline: * Had an exacerbation of asthma requiring hospitalization in the preceding 12 months. * Reporting asthma that has not been well-controlled (ie, symptoms occurring on \>2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months. * Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis. * Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit. * Confirmed or suspected COVID-19 infection within 4 weeks before the screening or baseline visit. * Previous treatment with dupilumab. * Pregnant women (positive urine pregnancy test result at the screening visit or the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study. * History of, current, or suspected lymphoproliferative disease or malignancy of any organ system within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit. * History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine. * Known active or latent tuberculosis (TB) infection. * Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment. * History of or current confounding skin condition (i.e., active atopic dermatitis, chronic urticaria, psoriasis, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis). * Planned or expected major surgical procedure during the clinical study. * Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study. * History of alcohol or substance abuse within 6 months of the screening. * History of poor wound healing or keloid formation.
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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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University of Michigan
Ann Arbor, Michigan, 48109, United States