Breast ReconstructionPhase 1NCT07264790
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
A Phase 1 study testing Minoxidil and Hair mousse in people with Breast Reconstruction and Perfusion; Complications, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer
- What is being tested?
- Minoxidil and Hair mousse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex > 18 years old
- Genetic predisposition to cancer
- Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
- Capable of giving informed consent
Who cannot join
- Diagnosis of breast cancer
- History of cancer
- Currently pregnant or planning to be pregnant (for women of child-bearing potential)
- Male sex
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Health
Durham, North Carolina, 27710
Jennifer Gallagher, BA, jennifer.gallagher@duke.edu
About this study
Official title: Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
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.
- Conditions
- Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
- Being tested
- Minoxidil, Hair mousse
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Hair mousseDrug
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil | Experimental | All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. Receives: Drug: Minoxidil |
| Hair mousse | Placebo comparator | All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. Receives: Drug: Hair mousse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by recruitment rate
Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Measured: Day 1
Feasibility, as measured by retention rate
Retention of enrolled participants until the clinical endpoint
Measured: 90 days
Feasibility, as measured by rate of participant adherence to the protocol
Rate of adherence to the treatment protocol
Measured: 90 days
Secondary outcomes (5)
Flap perfusion, assessed by a blinded plastic surgeon
A third-party blinded plastic surgeon will visually evaluate flap perfusion, from preoperative and intraoperative photos, and SPY-QP video and use their clinical judgement to assess perfusion.
Measured: Day of surgery
Flap perfusion, assessed by ICG angiography
Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point.
Measured: Day of surgery
Incidence of mastectomy skin flap necrosis
Measured: 90 days
Incidence of surgical complications
Measured: 90 days
Incidence of reoperations or definitive second-stage reconstruction
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start16 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett Phillips, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264790
- Sponsor's protocol ID
- Pro00116354
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07264790
- Acronym / sponsor ID
- Pro00116354
- Conditions
- Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil | Experimental | Drug: MinoxidilAll participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. |
| Hair mousse | Placebo comparator | Drug: Hair mousseAll participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex > 18 years old
- Genetic predisposition to cancer
- Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
- Capable of giving informed consent
Key exclusion criteria (4 listed)
- Diagnosis of breast cancer
- History of cancer
- Currently pregnant or planning to be pregnant (for women of child-bearing potential)
- Male sex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinoxidilEach participant will receive both topical agents in order to apply daily for 14-days prior to surgery. | Drug | Minoxidil |
| Hair mousseEach participant will receive both topical agents in order to apply daily for 14-days prior to surgery. | Drug | Hair mousse |
Primary outcome
Feasibility, as measured by recruitment rate
Time frame: Day 1
Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Feasibility, as measured by retention rate
Time frame: 90 days
Retention of enrolled participants until the clinical endpoint
Feasibility, as measured by rate of participant adherence to the protocol
Time frame: 90 days
Rate of adherence to the treatment protocol
5 secondary outcomes
Flap perfusion, assessed by a blinded plastic surgeon
Time frame: Day of surgery
Flap perfusion, assessed by ICG angiography
Time frame: Day of surgery
Incidence of mastectomy skin flap necrosis
Time frame: 90 days
Incidence of surgical complications
Time frame: 90 days
Incidence of reoperations or definitive second-stage reconstruction
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett Phillips, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minoxidil and Hair mousse in people with Breast Reconstruction and Perfusion; Complications, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Gallagher (9199701551, jennifer.gallagher@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by recruitment rate (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.