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The Journal of Clinical and Aesthetic... May 2024We sought to review published literature on antibiotic and antiseptic use and resistance, and explore the utility of benzoyl peroxide in this capacity for dermatologic... (Review)
Review
OBJECTIVE
We sought to review published literature on antibiotic and antiseptic use and resistance, and explore the utility of benzoyl peroxide in this capacity for dermatologic surgery.
METHODS
A literature review was performed to investigate the skin microbiome, guidelines on antibiotic and antiseptic use in dermatologic surgery, and the utility of benzoyl peroxide as an antiseptic.
RESULTS
Antiseptics are commonly used in dermatologic surgery to prepare surgical sites, and antibiotics are also employed by some physicians to prevent post-operative infection despite the potential for antibiotic resistance. Benzoyl peroxide, known for its high threshold for antibiotic resistance, has been successfully used in orthopedic surgery to prevent surgical site infection, especially in sebaceous areas of the skin which house a distinct microbiota.
LIMITATIONS
Limitations to this review include lack of high-quality, adequately powered research and studies which evaluate the clinical impact of anti-septic use, particularly benzoyl peroxide use, in dermatologic surgery.
CONCLUSION
Benzoyl peroxide may be a used as an antiseptic in dermatologic surgery of sebaceous areas to prevent post-operative infections, with a low likelihood of causing microbial resistance.
PubMed: 38779372
DOI: No ID Found -
The Journal of Clinical and Aesthetic... Aug 2023A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and...
OBJECTIVE
A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials.
METHODS
In two 12-week, randomized, double-blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle.
RESULTS
In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all <0.001). The difference was also significant at Week 2. There were no treatment-related serious adverse events; 1.4 percent of subjects (1.8% E-BPO cream, 5%, 0.4% vehicle) discontinued due to adverse events. Assessed local tolerability was found to be similar among subjects in both E-BPO and vehicle.
UNLABELLED
E-BPO was not compared with unencapsulated BPO.
CONCLUSION
E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939.
PubMed: 37636253
DOI: No ID Found -
The Journal of Dermatological Treatment Dec 2023Using a three-pronged acne treatment approach-combining an antibiotic, antimicrobial agent, and retinoid-may provide greater efficacy than monad or dyad treatments.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Using a three-pronged acne treatment approach-combining an antibiotic, antimicrobial agent, and retinoid-may provide greater efficacy than monad or dyad treatments. Herein are the dermal sensitization, irritation, safety, and tolerability results from phase 1 and 2 studies of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) polymeric mesh gel.
METHODS
Two phases 1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase 2 (NCT03170388) double-blind, randomized, parallel-group, and vehicle-controlled study was conducted over 12 weeks in participants aged ≥9 years with moderate-to-severe acne.
RESULTS
A total of 1,020 participants (IDP-126 gel, vehicle, or 1 of the 3 dyad gels [phase 2 only]) were included across the 3 studies (safety populations: = 1,004). In the phase 1 studies, IDP-126 had no confirmed sensitization or contact dermatitis. IDP-126 (deemed "moderately irritating") was significantly less irritating than commercially available BPO 2.5%/adapalene 0.3% gel.
CONCLUSIONS
The results from these three studies show that the triple-combination IDP-126 had a positive safety profile and was well tolerated in healthy participants and those with moderate-to-severe acne.
Topics: Humans; Adolescent; Adult; Adapalene; Peroxides; Single-Blind Method; Benzoyl Peroxide; Acne Vulgaris
PubMed: 37341243
DOI: 10.1080/09546634.2023.2220446 -
Cutis Aug 2023A range of treatment options are available for both mild to moderate and moderate to severe acne, and these options vary widely in their clinical uses, effectiveness,... (Review)
Review
A range of treatment options are available for both mild to moderate and moderate to severe acne, and these options vary widely in their clinical uses, effectiveness, and costs. With the continued rise of dermatologic drug prices and increased cost-sharing due to high-deductible health plans, the importance of cost-effective treatment continues to grow. Failure to consider cost-effective, patient-centered care may lead to increased financial toxicity, reduced adherence, and ultimately worse outcomes and patient satisfaction. Combination topical products offer improved efficacy and convenience, which are associated with better adherence and outcomes. Generic fixed-dose adapalene-benzoyl peroxide (BPO) and fixed-dose clindamycin-BPO can be highly cost-effective options for patients with mild to moderate acne. Hormonal agents such as combined oral contraceptives (COCs) and spironolactone are inexpensive and likely reflect a highly cost-effective option that could reduce reliance on oral antibiotics in patients with moderate to severe acne. Doxycycline and isotretinoin also are cost-effective options for more severe acne. Frequent laboratory monitoring for spironolactone and isotretinoin continues to be prevalent despite little evidence to support its clinical utility, and it is associated with a major cost burden to the patient and health care system. The reduction of laboratory monitoring is an opportunity to provide higher-value care.
Topics: Humans; Dermatologic Agents; Benzoyl Peroxide; Isotretinoin; Adapalene; Cost-Benefit Analysis; Spironolactone; Drug Combinations; Acne Vulgaris; Treatment Outcome; Gels
PubMed: 37820334
DOI: 10.12788/cutis.0844 -
Journal of the American Academy of... Nov 2023A three-pronged acne treatment approach-combining an antibiotic, antibacterial agent, and retinoid-may provide greater efficacy than single/double treatments. Topical...
BACKGROUND
A three-pronged acne treatment approach-combining an antibiotic, antibacterial agent, and retinoid-may provide greater efficacy than single/double treatments. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (IDP-126) is the first fixed-dose triple-combination in development for acne.
OBJECTIVE
To confirm efficacy, safety, and tolerability of IDP-126 gel in acne treatment.
METHODS
Two phase 3, double-blind, 12-week studies randomized participants aged ≥9 years with moderate-to-severe acne (N = 183; N = 180) 2:1 to once-daily IDP-126 or vehicle gel. Co-primary endpoints comprised participants achieving ≥2-grade reduction from baseline in Evaluator's Global Severity Score (EGSS) and clear/almost clear skin (treatment success) and change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed.
RESULTS
At week 12, 49.6% and 50.5% of participants achieved treatment success with IDP-126 versus 24.9% and 20.5% with vehicle (P < .01, both). IDP-126 also provided significantly greater reductions in inflammatory/noninflammatory lesions versus vehicle (least-squares mean percent range: 72.7% to 80.1% vs 47.6% to 59.6%; P < .001, all). Most TEAEs were of mild-moderate severity.
LIMITATIONS
Inter-observer bias/variation in acne severity ratings, limited treatment duration, and population differences that may not generalize to real-world populations.
CONCLUSION
The innovative fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in 2 clinical studies of participants with moderate-to-severe acne.
PubMed: 37656094
DOI: 10.1016/j.jaad.2022.08.069 -
The Journal of Dermatological Treatment Dec 2024Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical... (Review)
Review
Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV. Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed. According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low.
Topics: Humans; Clindamycin; Retrospective Studies; Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide
PubMed: 38568005
DOI: 10.1080/09546634.2024.2325603 -
Environmental Health Perspectives Mar 2024
Topics: Benzene; Benzoyl Peroxide
PubMed: 38483533
DOI: 10.1289/EHP13984 -
Dermatology and Therapy Feb 2024Encapsulated benzoyl peroxide, 5%, for rosacea and a combined formulation of encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, for acne vulgaris, utilize...
Encapsulated benzoyl peroxide, 5%, for rosacea and a combined formulation of encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, for acne vulgaris, utilize microencapsulation, a process by which active pharmaceutical agents are enclosed in inert, permeable silica shells that provide a buffer between the drug and the skin. The silica shells allow a gradual release of the drug while also allowing combinations of active ingredients that would not otherwise be possible. This technology allows benzoyl peroxide and tretinoin to be combined in the same vehicle without risking the benzoyl peroxide-mediated oxidative destruction of tretinoin. In the current study, we queried the Galderma pharmacovigilance database to quantify and categorize adverse events associated with using these products in the USA during a 12-month period from May 2022 through April 2023. The adverse events were generally mild and restricted to local irritation, pruritus, burning sensation, and erythema. The real-world incidence and type of adverse events reported by the community for encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, and benzoyl peroxide, 5%, were consistent with the safety and tolerability findings from the phase III clinical studies of these treatments.
PubMed: 38243147
DOI: 10.1007/s13555-023-01095-8 -
Drugs Mar 2024Rosacea, a chronic skin condition affecting millions of people in the USA, leads to significant social and professional stigmatization. Effective management strategies... (Review)
Review
Rosacea, a chronic skin condition affecting millions of people in the USA, leads to significant social and professional stigmatization. Effective management strategies are crucial to alleviate symptoms and improve patients' quality of life. Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a newly FDA-approved topical treatment for rosacea that shows promise in enhancing therapeutic response and minimizing skin irritation. This review aims to assess the role of recently FDA approved E-BPO 5% in the current treatment landscape for rosacea management, as it is not yet included in clinical guidelines that predominantly rely on older approved therapies. The review focuses on randomized controlled trials conducted in English-speaking adults. It evaluates the efficacy, safety, and tolerability of various US Food and Drug Administration (FDA)-approved agents used for rosacea treatment, including E-BPO cream, metronidazole gel, azelaic acid gel and foam, ivermectin cream, minocycline foam, oral doxycycline, brimonidine gel, and oxymetazoline HCl cream. Existing therapies have been effective in reducing papulopustular lesions and erythema associated with rosacea for many years. E-BPO 5% offers a promising addition to the treatment options due to its microencapsulation technology, which prolongs drug delivery time and aims to improve therapeutic response while minimizing skin irritation. Further research is necessary to determine the exact role of E-BPO 5% in the therapeutic landscape for rosacea. However, based on available evidence, E-BPO 5% shows potential as a valuable treatment option for managing inflammatory lesions of rosacea, and it may offer benefits to patients including: rapid onset of action, demonstrated efficacy by Week 2, excellent tolerability, and sustained long-term results for up to 52 weeks of treatment.
Topics: Adult; Humans; Benzoyl Peroxide; Dermatologic Agents; Metronidazole; Quality of Life; Rosacea; Randomized Controlled Trials as Topic
PubMed: 38418773
DOI: 10.1007/s40265-024-02003-w -
Dermatology and Therapy Feb 2024Rosacea is a common, chronic inflammatory disease characterized by both fluctuating and fixed heterogeneous signs such as facial erythema, papules/pustules,...
Rosacea is a common, chronic inflammatory disease characterized by both fluctuating and fixed heterogeneous signs such as facial erythema, papules/pustules, telangiectasia, acute vasodilation (flushing), and phymatous changes, and symptoms such as cutaneous stinging and burning. The shift to a phenotype-based approach to rosacea management has improved the consistency of recommendations across recent published guidelines. Consistent and thorough guidance for the classification, diagnosis, and management of the disease is difficult, as the mechanisms underlying the development of rosacea are still not completely understood nor universally accepted. Here, we provide a critical review of current published guidance, and gaps in the knowledge and management of rosacea. We present the recently approved microencapsulated benzoyl peroxide as an effective topical treatment option for papulopustular rosacea. Benzoyl peroxide (BPO) has been used in acne management for many years; however, many clinicians perceive treatment of rosacea with any BPO formulation to be counterintuitive because of concerns of potential skin irritation, while the lack of an accepted mechanism of action on rosacea pathophysiology means that others may be hesitant to use BPO as a treatment. Minocycline foam 1.5% is also an option for the treatment of inflammatory lesions in rosacea, with a decreased risk of systemic adverse events compared with oral minocycline.
PubMed: 38194021
DOI: 10.1007/s13555-023-01087-8