Recruiting
Phase 1

Minoxidil

Sponsor:

Duke University

Code:

NCT07264790

Conditions

Breast Reconstruction

Perfusion; Complications

High Risk for Breast Cancer

Genetic Predisposition

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Minoxidil

Hair mousse

Study Details

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

Study ID

NCT07264790

Start date

Mar 16, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Minoxidil

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.

placebo comparator: Hair mousse

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.

Interventions

Minoxidil

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

Hair mousse

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

Primary outcome measure

  • Feasibility, as measured by recruitment rate [ Time Frame: Day 1 ]
  • Feasibility, as measured by retention rate [ Time Frame: 90 days ]
  • Feasibility, as measured by rate of participant adherence to the protocol [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Duke Health

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jennifer Gallagher, BA

jennifer.gallagher@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jul 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-08.