Painless patch could replace needles for drug delivery
NCT ID NCT07615959
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new wearable patch called the Medicsen Smartpatch, which uses ultrasound to push medicine through the skin without needles. Thirty healthy volunteers will receive a drug both by patch and by standard injection, then compare safety, comfort, and how well the drug enters the bloodstream. The goal is to see if the patch is a safe and effective alternative to injections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Nov 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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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Subjects must provide signed informed consent prior to participation in any study related procedures * Healthy Caucasian volunteers, any sex, aged between 18 to 55 years * Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 * Ability and agreement to comply with the study requirements * Medical history and physical examination within normal limits. * No clinically relevant abnormalities in hematology, biochemistry, virology, or urine tests. * Participants who engage in sexual activity which could result in pregnancy for themselves or their partner(s) must agree to use highly effective methods of contraception during the clinical investigation. Exclusion Criteria: * Case history of hypersensitivity to medicinal products or any other allergic process that could interfere with study according to the investigator's judgement. * Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, dermatology, gastrointestinal distress, hypertension, or infectious acute processes that could interfere with study according to the investigator's judgement. * Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgement. * Administration of topic or systemic medication including medicinal plants within 14 days before the intervention. * Presence of skin disorders or lesions at the intended application site (e.g., eczema, psoriasis, infections, open wounds), which may interfere with drug absorption or increase risk of adverse effects. * Implanted electronic medical devices, such as pacemakers or neurostimulators, due to potential interference with ultrasonic energy. * Pregnant or breastfeeding women, due to lack of safety data for either the drug or the ultrasound application in this population. * Severe cognitive or motor impairment, where safe operation of the patch cannot be ensured, unless under continuous caregiver supervision.
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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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Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034, Spain
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