NCT07264790 Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
| NCT ID | NCT07264790 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Duke University |
| Condition | Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-04 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used. This will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles "compound A" and "compound B" with directions from the pharmacy for which compound to apply to each breast. Product will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.
Eligibility Criteria
Inclusion Criteria: 1. Female sex \> 18 years old 2. Genetic predisposition to cancer 3. Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction 4. Capable of giving informed consent Exclusion Criteria: 1. Diagnosis of breast cancer 2. History of cancer 3. Currently pregnant or planning to be pregnant (for women of child-bearing potential) 4. Male sex
Contact & Investigator
Brett Phillips, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07264790 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07264790 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07264790 currently recruiting?
Yes, NCT07264790 is actively recruiting participants. Contact the research team at jennifer.gallagher@duke.edu for enrollment information.
Where is the NCT07264790 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07264790 clinical trial?
NCT07264790 is sponsored by Duke University. The principal investigator is Brett Phillips, MD at Duke University. The trial plans to enroll 25 participants.