Recruiting
Phase 4

Finasteride

Sponsor:

University of Washington

Code:

NCT07731802

Conditions

Dihydrotestosterone

Periprosthetic Joint Infection (PJI)

Cutibacterium Acnes

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Finasteride 5 mg

Placebo Control

Study Details

Brief summary:

High levels of Testosterone causes high amounts of skin bacteria (Cutibacterium Acnes) which can go into the skin during a shoulder replacement surgery and cause a terrible infection.

The goal of this experiment is to have participants take Finasteride, a medication that blocks testosterone production, for 2 weeks and evaluate the following:

  • Blood levels of testosterone
  • Amount of bacteria on the skin.

Participants will:

  • Be assigned to take Finasteride, or a placebo (a look-alike pill with no active medicine) once daily, for 2 weeks
  • Have a small sample of their blood collected and their skin swabbed with a Q-tip to determine Testosterone levels and bacteria on the skin
  • Blood draw and skin testing will take place before starting Finasteride or the placebo (day 0) and at the end of the experiment (day 14).

Conditions

Dihydrotestosterone

Periprosthetic Joint Infection (PJI)

Cutibacterium Acnes

Study ID

NCT07731802

Start date

Aug 31, 2026

Status verified date

Nov, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion We will include the group most impacted by PJI

  • Adult males
  • Age between 18 and 65 Exclusion
  • History of cryptorchidism, hypospadias, or other congenital abnormality of male reproductive tract
  • Female sex
  • Age younger than 18 or older than 65
  • Current use of Finasteride or other 5-alpha reductase inhibitors
  • Current use of hormone replacement medications such as testosterone
  • Recent antibiotic use within 3 months
  • Have had a negative reaction to oral Finasteride before
  • Recent use of acne treatment within 3 months
  • Self-report very sensitive skin
  • Allergic to chlorhexidine or isopropyl alcohol
  • Have open wounds on both shoulders

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Finasteride group

placebo comparator: Placebo group

Interventions

Finasteride 5 mg

Patients randomized to the experimental group will receive oral Finasteride 1 mg, taken daily, for two weeks

Placebo Control

Patients randomized to the placebo group will receive one pill containing no active medicine, taken daily, for two weeks.

Primary outcome measure

  • Cutibacterium skin load [ Time Frame: Skin load will be assessed at day 0 and at the end of the study on day 14 of treatment or placebo. ]
  • Serum Dihydrotestosterone (DHT) Level [ Time Frame: levels will be assessed at baseline and after 14 consecutive days of treatment or placebo. ]

Central Contacts and Locations

Central contacts

Anastasia Whitson

206-755-7847whitsa@uw.edu

Locations

UW Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Anastasia Whitson Research Coordinator

206-755-7847whitsa@uw.edu

Principal Investigator:

Corey Schiffman, MD

More Information

Sponsor

University of Washington

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • placebo
  • blood draw
  • skin culture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.