Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon

NCT07264790 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro00116354
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Perfusion; Complications; High Risk for Breast Cancer; Genetic Predisposition

Outcome Measures

Primary Outcomes (3)

• Feasibility, as measured by recruitment rate

  Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction

  Day 1

• Feasibility, as measured by retention rate

  Retention of enrolled participants until the clinical endpoint

  90 days

• Feasibility, as measured by rate of participant adherence to the protocol

  Rate of adherence to the treatment protocol

  90 days

Secondary Outcomes (5)

• Flap perfusion, assessed by a blinded plastic surgeon

  Day of surgery

• Flap perfusion, assessed by ICG angiography

  Day of surgery

• Incidence of mastectomy skin flap necrosis

  90 days

• Incidence of surgical complications

  90 days

• Incidence of reoperations or definitive second-stage reconstruction

  90 days

Study Arms (2)

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.

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.

Drug: Hair mousse

Interventions

Minoxidil DRUG

Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.

Minoxidil

Hair mousse DRUG

Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.

Hair mousse

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: High-risk for breast cancer diagnosis with desire to proceed with breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex \> 18 years old
• Genetic predisposition to cancer
• Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
• Capable of giving informed consent

You may not qualify if:

• Diagnosis of breast cancer
• History of cancer
• Currently pregnant or planning to be pregnant (for women of child-bearing potential)
• Male sex

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Brett Phillips, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Gallagher

CONTACT

9199701551; jennifer.gallagher@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)