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

NCT ID: NCT07264790

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-09-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Minoxidil

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Hair mousse

Intervention Type: DRUG

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

Interventions

Minoxidil

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

Intervention Type: DRUG

Hair mousse

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Health

Durham, North Carolina, United States

Countries

United States

Central Contacts

Jennifer Gallagher

Role: CONTACT

jennifer.gallagher@duke.edu

9199701551

Facility Contacts

Jennifer Gallagher, BA

Role: primary

jennifer.gallagher@duke.edu

Other Identifiers

Pro00116354

Identifier Type: -

Identifier Source: org_study_id