Finasteride and Cutibacterium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finasteride 1 mg, Placebo Control.
- Who it may be relevant to
- Registry conditions: Dihydrotestosterone, Periprosthetic Joint Infection (PJI), Cutibacterium Acnes. Basic parameters: 18 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Drug Finasteride 1 mg
Patients randomized to the experimental group will receive oral Finasteride 1 mg, taken daily, for two weeks - Drug Placebo Control
Patients randomized to the placebo group will receive one pill containing no active medicine, taken daily, for two weeks.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07731802 · STUDY00025632