Finasteride and Cutibacterium
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversity of Washington
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult males
Age between 18 and 65 Exclusion
History of cryptorchidism, hypospadias, or other congenital abnormality of male reproductive tract
Female sex
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Finasteride 1 mg
DrugPatients randomized to the experimental group will receive oral Finasteride 1 mg, taken daily, for two weeks
Placebo Control
DrugPatients randomized to the placebo group will receive one pill containing no active medicine, taken daily, for two weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Finasteride groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cutibacterium skin load
Skin load will be determined using bacterial culture of the skin and assigning a value based on the report from the microbiology lab: 0 for "no growth"; 0.1 for "growth of 1 colony only" or for "growth in broth only"; and 1, 2, 3 and 4 for 1+, 2+, 3+ and 4+ growth, respectively. Mann-Whitney U test will be used to compare the change in the semi-quantitative skin load at baseline and day 14 in the intervention and control group, along with comparison of the percentage of subjects in each group that began with a high baseline skin load (\>2) and ended with a low skin load (≤1).
Time frame
Skin load will be assessed at day 0 and at the end of the study on day 14 of treatment or placebo.2
Serum Dihydrotestosterone (DHT) Level
Participants blood will be collected and processed for serum DHT level by the certified and state-licensed phlebotomists and clinical laboratory technicians at our intuition, which is in the same building as the outpatient clinic.
Time frame
levels will be assessed at baseline and after 14 consecutive days of treatment or placebo.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: