What side effects are associated with this type of intervention?

The most common treatments for osteoarthritis include nonsteroidal anti-inflammatory drugs (NSAIDs), both nonselective (e.g., ibuprofen, naproxen) and COX-2 selective inhibitors (e.g., celecoxib). Known side effects of NSAIDs include gastrointestinal issues (such as ulcers and bleeding), cardiovascular risks (such as increased risk of heart attack and stroke), and renal problems. Celecoxib, a COX-2 selective inhibitor, has a higher rate of gastrointestinal adverse effects compared to placebo. Glucosamine and chondroitin, often used in combination, are generally well-tolerated but can cause mild gastrointestinal symptoms like nausea, diarrhea, and constipation.

What prior FDA approvals exist?

FDA-approved treatments for osteoarthritis primarily include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, corticosteroid injections, and hyaluronic acid injections. Additionally, analgesics like acetaminophen and topical treatments such as capsaicin are also approved. For more severe cases, surgical options like joint replacement may be considered. There are no specific FDA-approved treatments for osteoarthritis that involve Propionibacterium acnes or similar bacterial colonization studies.

What other types of research exist?

Promising novel alternatives for monitoring and managing bacterial colonization in osteoarthritis patients include: 1) Advanced molecular diagnostic techniques such as 16S rRNA sequencing and metagenomic next-generation sequencing for precise identification of bacterial presence. 2) Use of antibiotic-impregnated bone cement and collagen sponges to prevent bacterial colonization during joint replacement surgeries. 3) Implementation of timely and appropriate antibiotic prophylaxis protocols to reduce the risk of surgical site infections. 4) Exploring the role of probiotics and prebiotics in modulating the skin microbiome to potentially reduce harmful bacterial colonization.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and tissues samples taken at the time of surgery will be held for 14 days for reporting.

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 • NCT00713609

Nasopharyngitis

Upper respiratory tract infection

Application site irritation

Application site pruritus

Influenza

Headache

Dermatitis

Fibromatosis

Application site dermatitis

Dyspepsia

Back pain

Application site burn

Dry skin

Condition aggravated

Nausea

Skin irritation

Application site dryness

Pyrexia

Allergy to arthropod bite

Oral herpes

Sinusitis

Sunburn

Nasal congestion

Pharyngolaryngeal pain

Skin exfoliation

100%

80%

60%

40%

20%

Study treatment Arm

Vehicle Gel + Tazarotene

Benzoyl Peroxide Gel + Tazarotene

Vehicle Gel + Vehicle Cream

Clindamycin Gel + Tazarotene

Benzoyl Peroxide/Clindamycin + Vehicle Cream

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

0 / 7Eligibility criteria met

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.