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Benzoyl Peroxide Gel for Total Hip Arthroplasty
Phase 4
Recruiting
Led By Jason M Jennings, MD DPT
Research Sponsored by Colorado Joint Replacement
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CJR patients without a previous arthroplasty procedure who have established care with our practice.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tissues samples taken at the time of surgery will be held for 14 days
Awards & highlights
Study Summary
This trial is testing how well a low-virulence bacterium, Propionibacterium (P) acnes, grows on hips. P. acnes is the same bacterium that causes acne. Information about how this bacterium affects hip surgery is currently unknown.
Who is the study for?
This trial is for patients aged 18-85 who are undergoing primary hip or knee replacement at Porter Adventist Hospital without a previous joint replacement on the biopsy side. They must not have had a hip infection, be using antibiotics recently, have active psoriatic disease over the hip, Cutibacterium joint infections, or any immunodeficiency diseases.Check my eligibility
What is being tested?
The study tests Benzoyl peroxide gel's effect on reducing colonization of P acnes bacteria in the skin around the hip area. This bacterium is commonly associated with acne but its role in affecting outcomes after total hip arthroplasty (hip replacement surgery) is unknown.See study design
What are the potential side effects?
While not explicitly stated for this trial, Benzoyl peroxide gel typically can cause skin irritation including dryness, peeling, redness and slight swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had joint replacement surgery before and am a patient at this practice.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tissues samples taken at the time of surgery will be held for 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tissues samples taken at the time of surgery will be held for 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Side effects data
From 2009 Phase 2 trial • 591 Patients • NCT007136094%
Nasopharyngitis
4%
Upper respiratory tract infection
2%
Application site pruritus
2%
Headache
2%
Dermatitis
2%
Application site irritation
2%
Influenza
1%
Dyspepsia
1%
Nausea
1%
Application site burn
1%
Application site dryness
1%
Pyrexia
1%
Oral herpes
1%
Sinusitis
1%
Sunburn
1%
Back pain
1%
Fibromatosis
1%
Dry skin
1%
Application site dermatitis
1%
Condition aggravated
1%
Allergy to arthropod bite
1%
Nasal congestion
1%
Pharyngolaryngeal pain
1%
Skin exfoliation
1%
Skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Gel + Tazarotene
Vehicle Gel + Vehicle Cream
Clindamycin Gel + Tazarotene
Benzoyl Peroxide Gel + Tazarotene
Benzoyl Peroxide/Clindamycin + Tazarotene
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Skin Prep with BPOExperimental Treatment1 Intervention
Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths.
Following the CHG wipes, patients will be prepped with 5% BPO gel applied directly to the biopsy site.
After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.
Group II: Standard Skin PrepActive Control1 Intervention
Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths.
After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzoyl peroxide
FDA approved
Find a Location
Who is running the clinical trial?
Colorado Joint ReplacementLead Sponsor
11 Previous Clinical Trials
2,725 Total Patients Enrolled
3 Trials studying Osteoarthritis
123 Patients Enrolled for Osteoarthritis
Jason M Jennings, MD DPTPrincipal InvestigatorColorado Joint Replacement
1 Previous Clinical Trials
460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a natural hip joint and am volunteering for research on knee or hip replacement.I have had a hip infection in the past.I have active psoriasis or inflammation over my hip.I have had a total hip replacement surgery on both sides.I have a condition that weakens my immune system.I have had a joint infection caused by Cutibacterium.I have not had joint replacement surgery before and am a patient at this practice.I am between 18 and 85 years old.I am currently taking antibiotics or have taken them in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Skin Prep
- Group 2: Experimental Skin Prep with BPO
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any adverse effects of Benzoyl peroxide gel?
"Benzoyl peroxide gel has completed Phase 4 clinical trials, and thus it is safe according to our team's 3-point scale."
Answered by AI
Who might this clinical trial be most beneficial for?
"This trial is meant for those who suffer from arthrosis and are between 18-85 years old. The study needs 496 individuals in total to participate."
Answered by AI
How many human participants are in this clinical research project?
"As of right now, this trial is not recruiting any more patients. The listing for this clinical study was first posted on February 2nd, 2019 and updated as recently as August 2nd, 2021. However, there are 644 other trials actively looking for patients with arthrosis and 4 studies related to Benzoyl peroxide gel that still need participants."
Answered by AI
Do we have any previous research to fall back on regarding Benzoyl peroxide gel?
"As of now, there are 4 different ongoing clinical trials studying the effects of Benzoyl peroxide gel. 1 of these studies is currently in Phase 3. Most research centres for this medication are located in Boston, but there are a total of 13 sites conducting trials for Benzoyl peroxide gel."
Answered by AI
Are there any vacancies in this research program for new volunteers?
"This study has completed recruitment for participants. The trial was posted on February 2nd, 2019 and last updated on August 2nd, 2021. There are 644 other trials actively searching for patients with arthrosis and 4 studies involving Benzoyl peroxide gel that are also looking for volunteers."
Answered by AI
Are people of an older age still being recruited for this research project?
"The age limit for this study is 85 years old. All participants must be above 18 years of age."
Answered by AI
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