Finasteride and Cutibacterium
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).
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Anastasia Whitson
- Telefonnummer: 206-755-7847
- E-post: whitsa@uw.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebogrupp
|
Patients randomized to the placebo group will receive one pill containing no active medicine, taken daily, for two weeks.
|
|
Experimentell: Finasteride group
|
Patients randomized to the experimental group will receive oral Finasteride 1 mg, taken daily, for two weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cutibacterium skin load
Tidsram: Skin load will be assessed at day 0 and at the end of the study on day 14 of treatment or placebo.
|
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). |
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
Tidsram: levels will be assessed at baseline and after 14 consecutive days of treatment or placebo.
|
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.
|
levels will be assessed at baseline and after 14 consecutive days of treatment or placebo.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Corey Schiffman, MD, University of Washington
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00025632
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