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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
Must not have
Previous history of hip infection
Patients with active psoriatic disease or other focal inflammation over the hip
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tissues samples taken at the time of surgery will be held for 14 days
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial investigates how quickly a bacteria known for causing acne grows in patients who have had hip replacement surgery. The goal is to see if this bacteria might be causing infections after the surgery.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a hip infection in the past.
Select...
I have active psoriasis or inflammation over my hip.
Select...
I have had a total hip replacement surgery on both sides.
Select...
I have a condition that weakens my immune system.
Select...
I have had a joint infection caused by Cutibacterium.
Select...
I am currently taking antibiotics or have taken them in the last week.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heart rate
Side effects data
From 2009 Phase 2 trial • 591 Patients • NCT007136095%
Nasopharyngitis
4%
Application site pain
4%
Sinusitis
2%
Joint injury
2%
Application site burn
2%
Application site exfoliation
2%
Application site pruritus
2%
Smear cervix abnormal
2%
Back pain
2%
Application site dryness
2%
Application site erythema
2%
Gastroenteritis viral
2%
Pharyngitis
2%
Upper respiratory tract infection
2%
Sinus congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Gel + Vehicle Cream
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Benzoyl Peroxide Gel + Tazarotene
Clindamycin Gel + Tazarotene
Vehicle Gel + Tazarotene
Benzoyl Peroxide/Clindamycin + Tazarotene
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Osteoarthritis (OA) include analgesics, NSAIDs, and glucocorticoids. Analgesics like acetaminophen work by inhibiting the brain's pain perception pathways, providing symptomatic relief.
NSAIDs, such as naproxen and ibuprofen, reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the inflammatory process. Glucocorticoids, like prednisone, reduce inflammation by suppressing the immune response and decreasing the production of inflammatory mediators.
These treatments are crucial for OA patients as they help manage pain and improve joint function, although they do not halt disease progression. While the study on Propionibacterium acnes focuses on bacterial colonization, it highlights the importance of understanding all factors that may impact joint health and treatment efficacy.
Treatment of primary and secondary osteoarthritis of the knee.
Treatment of primary and secondary osteoarthritis of the knee.
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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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