A randomized controlled double-blinded split-face prospective clinical trial to assess the efficacy, safety, and tolerability of a novel 3-step routine compared to benzoyl peroxide for the treatment of mild to moderate acne vulgaris.

Adult acne vulgaris affects up to 43-51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid, and graduated retinol regimen versus a common OTC BPO-based regimen over 12 weeks. A total of 37 adult subjects with self-reported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, the novel routine outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. "I would use this in the future) and performance ("my skin improved" and "helped my acne clear up faster"). Users of the novel routine reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (novel routine) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability the novel routine was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p = 0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris.

A break-even analysis of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.

BACKGROUND: Newer strategies to decolonize the shoulder of Cutibacterium acnes may hold promise in minimizing the occurrence of infections after shoulder arthroplasty, but little is known about their cost-effectiveness. Break-even models can determine the economic viability of interventions in settings with low outcome event rates that would realistically preclude a randomized clinical trial. We used such modeling to determine the economic viability of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty. METHODS: Skin decolonization protocol costs ($11.76 for benzoyl peroxide; $0.96 for hydrogen peroxide), baseline infection rates for shoulder arthroplasty (0.70%), and infection-related care costs ($50,230) were derived from institutional records and the literature. A break-even equation incorporating these variables was developed to determine the absolute risk reduction (ARR) in the infection rate to make prophylactic use economically justified. The number needed to treat was calculated from the ARR. RESULTS: Topical benzoyl peroxide is considered economically justified if it prevents at least 1 infection out of 4348 shoulder arthroplasties (ARR = 0.023%). Hydrogen peroxide is economically justified if it prevents at least 1 infection out of 50,000 cases (ARR = 0.002%). These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs. CONCLUSIONS: The use of topical benzoyl peroxide and skin preparations with hydrogen peroxide are highly economically justified practices for infection prevention in shoulder arthroplasty. Efforts to determine drawbacks of routine skin decolonization strategies are warranted as they may change the value analysis.

Cutibacterium acnes persists despite topical clindamycin and benzoyl peroxide.

BACKGROUND: Cutibacterium (formerly Propionibacterium) acnes persists in the dermis despite standard skin antiseptic agents, prompting some surgeons to use topical antimicrobials such as benzoyl peroxide and clindamycin prior to shoulder arthroplasty surgery. However, the efficacy of these topical agents has not been established. METHODS: The upper backs of 12 volunteers were randomized into 4 treatment quadrants: topical benzoyl peroxide, topical clindamycin, combination topical benzoyl peroxide and clindamycin, and a negative control. The corresponding topical agents were applied to each site twice daily for 3 days. A 3-mm dermal punch biopsy specimen was obtained from each site and cultured for 14 days to assess for C acnes growth. Positive cultures were assessed for the hemolytic phenotype. The McNemar test was used to compare the proportion of positive cultures in each group. RESULTS: C acnes grew in 4 of 12 control sites (33.3%), 1 of 12 benzoyl peroxide sites (8.3%), 2 of 12 clindamycin sites (16.7%), and 2 of 12 combination benzoyl peroxide-clindamycin sites (16.7%). The C acnes hemolytic phenotype was present in 2 of 12 control specimens (16.7%) compared with 0 (0.0%) in the benzoyl peroxide group, 2 of 12 (16.7%) in the clindamycin group, and 2 of 12 (16.7%) in the combination benzoyl peroxide-clindamycin group. There were no statistically significant differences between treatment arms. CONCLUSION: The topical application of benzoyl peroxide and clindamycin did not eradicate C acnes in all subjects. The clinical implications of these findings are yet to be determined.

Topical benzoyl peroxide application on the shoulder reduces Propionibacterium acnes: a randomized study.

BACKGROUND: Propionibacterium acnes is a common cause of infection following shoulder surgery. Studies have shown that standard surgical preparation does not eradicate P acnes. The purpose of this study was to examine whether topical application of benzoyl peroxide (BPO) gel could decrease the presence of P acnes compared with today's standard treatment with chlorhexidine soap (CHS). We also investigated and compared the recolonization of the skin after surgical preparation and draping between the BPO- and CHS-treated groups. METHODS: In this single-blinded nonsurgical study, 40 volunteers-24 men and 16 women-were randomized to preoperative topical treatment at home with either 5% BPO or 4% CHS on the left shoulder at the area of a deltopectoral approach. Four skin swabs from the area were taken in a standardized manner at different times: before and after topical treatment, after surgical skin preparation and sterile draping, and 120 minutes after draping. RESULTS: Topical treatment with BPO significantly reduced the presence of P acnes measured as the number of colony-forming units on the skin after surgical preparation. P acnes was found in 1 of 20 subjects in the BPO group and 7 of 20 in the CHS group (P = .044). The results remained after 2 hours (P = .048). CONCLUSION: Topical preparation with BPO before shoulder surgery may be effective in reducing P acnes on the skin and preventing recolonization.

Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy.

BACKGROUND: Propionibacterium acnes is a gram-positive anaerobe that can lead to devastating postoperative shoulder infections. The objective of this study was to investigate whether a benzoyl peroxide and clindamycin preoperative skin preparation reduces the incidence of P. acnes colonization during shoulder arthroscopy. METHODS: Sixty-five shoulder arthroscopy patients were prospectively enrolled. A skin culture specimen was taken at the preoperative visit from standard arthroscopic portal sites. Topical benzoyl peroxide 5% and clindamycin 1.2% (BPO/C) gel was applied to the shoulder every night before surgery. Skin culture was repeated in the operating room before preparation with chlorhexidine gluconate. Shoulder arthroscopy proceeded, with final culture specimens obtained from within the shoulder. RESULTS: P. acnes skin colonization remained similar to prior studies at 47.7% (31 of 65 patients.) With >1 application, BPO/C was 78.9% (15 of 19 patients) effective in eliminating P. acnes superficial colonization. With 1 application, it was 66.7% (8 of 12 patients) effective in eliminating superficial colonization. Deep colonization was reduced to 3.1% (2 of 65 patients) compared with previous studies of 15% to 20% (P = .006). BPO/C was 100% effective at decreasing deep colonization with >1 application. CONCLUSIONS: P. acnes skin colonization is high at arthroscopic shoulder portals, especially in men. Despite standard skin preparation and prophylactic antibiotics, the rate of joint inoculation is much higher than the rate of infection reported in the literature. BPO/C effectively reduces P. acnes colonization in shoulder arthroscopy. It should be considered for use before shoulder procedures with a time-related trend of >1 application.

Successful co-encapsulation of benzoyl peroxide and chloramphenicol in liposomes by a novel manufacturing method - dual asymmetric centrifugation.

Encapsulation of more than one active pharmaceutical ingredient into nanocarriers such as liposomes is an attractive approach to achieve a synergic drug effect and less complicated dosing schedules in multi-drug treatment regimes. Liposomal drug delivery in acne treatment may improve drug efficiency by targeted delivery to pilosebaceous units, reduce adverse effects and improve patient compliance. We therefore aimed to co-encapsulate benzoyl peroxide (BPO) and chloramphenicol (CAM) into liposomes using the novel liposome processing method - dual asymmetric centrifugation (DAC). Liposomes were formed from soybean lecithin, propylene glycol and distilled water (2:1:2w/v/v ratio), forming a viscous liposome dispersion. Liposomes containing both drugs (BPO-CAM-Lip), single drug (BPO-Lip and CAM-Lip), and empty liposomes were prepared. Drug entrapment of BPO and CAM was determined by a newly developed HPLC method for simultaneous detection and quantification of both drugs. Encapsulation of around 50% for BPO and 60% for CAM respectively was obtained in both single-drug encapsulated formulations (BPO-Lip and CAM-Lip) and co-encapsulated formulations (BPO-CAM-Lip). Liposome sizes were comparable for all liposome formulations, ranging from 130 to 150nm mean diameter, with a polydispersity index <0.2 for all formulations. CAM exhibited a sustained release from all liposomal formulations, whereas BPO appeared retained within the liposomes. BPO retention could be attributed to its poor solubility. However, HaCaT cell toxicity was found dependent on BPO released from the liposomes. In the higher concentration range (4%v/v), liposomal formulations were less cytotoxic than the corresponding drug solutions used as reference. We have demonstrated that DAC is a fast, easy, suitable method for encapsulation of more than one drug within the same liposomes.

Topical and oral antibiotics for acne vulgaris.

Antibiotics, both oral and topical, have been an integral component of the management of acne vulgaris (AV) for approximately 6 decades. Originally thought to be effective for AV due to their ability to inhibit proliferation of Propionibacterium acnes, it is now believed that at least some antibiotics also exert anti-inflammatory effects that provide additional therapeutic benefit. To add, an increase in strains of P acnes and other exposed bacteria that are less sensitive to antibiotics used to treat AV have emerged, with resistance directly correlated geographically with the magnitude of antibiotic use. Although antibiotics still remain part of the therapeutic armamentarium for AV treatment, current recommendations support the following when used to treat AV: 1) monotherapy use should be avoided; 2) use benzoyl peroxide concomitantly to reduce emergence of resistant P acnes strains; 3) oral antibiotics should be used in combination with a topical regimen for moderate-to-severe inflammatory AV; and 4) use oral antibiotics over a limited duration to achieve control of inflammatory AV with an exit plan in place to discontinue their use as soon as possible. When selecting an oral antibiotic to treat AV, potential adverse effects are important to consider.

Over-the-counter treatments for acne and rosacea.

Acne and rosacea are common inflammatory processes historically classified in the same disease category, but evolving understanding of their disparate pathophysiology and exacerbating factors have generated an enormous armamentarium of therapeutic possibilities. Patients seek over-the-counter therapies first when managing cutaneous disease; therefore, this review defines ingredients considered to be effective over-the-counter acne and rosacea products, their mechanisms, and safe formulations, including botanical components, oral supplements, and other anecdotal options in this vast skin care domain.

Efficacy, tolerability and impact on quality of life of clindamycin phosphate and benzoyl peroxide for the treatment of cetuximab-associated acneiform eruption in patients with metastatic colorectal cancer.

BACKGROUND: Epidermal growth factor receptor inhibitors are recent antineoplastic treatments used for the treatment of some non-cutaneous tumours, which aberrantly express EGFR. Because of their specificity, these drugs have low systemic toxicity, but frequent undesired cutaneous effects, the most common of which is an acneiform eruption, occurring after 1-3 weeks of treatment. Management of this rash is not well standardized. OBJECTIVE: We evaluated efficacy, tolerability and impact on quality of life of a clindamycin phosphate 1.2%-benzoyl peroxide 5% gel in 12 male adults who developed acneiform eruption during treatment with cetuximab for metastatic colorectal cancer. METHODS: Patients applied the clindamycin phosphate-benzoyl peroxide gel once daily, at evening, for 8 weeks. The Skin-Score was used to evaluate reduction of erythema, papules, pustules and pruritus, the Dermatology Life Quality Index questionnaire to evaluate the improvements of health-related quality of life. RESULTS: Significant clinical improvements occurred after 2 weeks of treatment and were even more evident after 8 weeks (mean Skin-Score 20.54 ± 7.83, p = 1.37 × 10(-6) vs. second week visit, p = 1.26 × 10(-7) vs. before treatment). Accordingly, DLQI values decreased from 13.64 ± 2.01 before treatment to 6.45 ± 1.37 after 8 weeks (p = 1.12 × 10(-5)). CONCLUSION: A clindamycin phosphate-benzoyl peroxide gel may be an effective and safe option in the treatment of cetuximab-associated acneiform eruptions.

Acne isolated within a Becker nevus of a 14 year-old girl.

Becker nevus (BN) is a common benign condition occurring most often in young men, much more often than in women. Acne isolated within a BN is a rare phenomenon hypothesized to occur, at least in part, due to increased androgen sensitivity within the nevus. We present a rare case of papular acne with in a BN of a 14 year-old girl.

Randomized, phase 2, dose-ranging study in the treatment of rosacea with encapsulated benzoyl peroxide gel.

OBJECTIVE: Compare the safety and efficacy of 1% and 5% silica encapsulated benzoyl peroxide (E-BPO) in patients with papulopustular rosacea. DESIGN: Multi-centered randomized, double blind, vehicle controlled parallel group, 12 week treatment in 92 patients with papulopustular rosacea. Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions. PATIENTS: 92 patients: 74% graded as moderate IGA, 14% severe and 12% mild. The mean inflammatory lesion count was 24. INTERVENTION: Once daily treatment for 12 weeks with vehicle, 1% or 5% E-BPO. RESULTS: 1% and 5% E-BPO were superior to vehicle in reducing papulopustular lesions P =0.01 and P =0.02. 5% E-BPO was superior to vehicle for IGA P =0.0013.

Development and in-vitro characterization of fish oil oleogels containing benzoyl peroxide and salicylic acid as keratolytic agents.

Topical keratolytic agents such as benzoyl peroxide (BP) and salicylic acid (SA) are one of the common treatments for inflammatory skin diseases. However, the amount of drug delivery through the skin is limited due to the stratum corneum. The purposes of this study were to investigate the ability of fish oil to act as penetration enhancer for topical keratolytic agents and to determine the suitable gelator for formulating stable fish oil oleogels. 2 types of gelling agents, beeswax and sorbitan monostearate (Span 60), were used to formulate oleogels. To investigate the efficacy of fish oil oleogel permeation, commercial hydrogels of benzoyl peroxide (BP) and salicylic acid (SA) were used as control, and comparative analysis was performed using Franz diffusion cell. Stability of oleogels was determined by physical assessments at 20°C and 40°C storage. Benzoyl peroxide (BP) fish oil oleogels containing beeswax were considered as better formulations in terms of drug permeation and cumulative drug release. All the results were found to be statistically significant (p<0.05, ANOVA) and it was concluded that the beeswax-fish oil combination in oleogel can prove to be beneficial in terms of permeation across the skin and stability.

Rosacea: pathophysiology and management principles.

This article presents an overview of the pathophysiology, epidemiology, and clinical presentations of rosacea. It also presents the therapeutic spectrum for effective management of this challenging and often confusing clinical entity.

Acne vulgaris in children and adolescents.

Acne vulgaris is a very common inflammatory skin disease originating from the pilosebaceous unit. Peak incidence is at puberty, but acne can affect all age groups. Prepubertal acne is rare, but important to recognize as diagnostic and therapeutic procedures differ from pubertal acne. Acne neonatorum is a mild, self-limiting disease, whereas acne infantum commonly presents with moderate to severe lesions and high risk of scarring thus requiring early intervention. Mid-childhood or prepubertal acne raises the suspicion of hyperandrogenemia, further investigations are indicated to rule out underlying disease. The same applies to any patient with very severe acne, acne not responding to therapy or unusual clinical presentation. Etiopathogenesis of acne is not yet fully understood. Familiy history is the most important risk factor to develop severe acne and scarring. The relevance of life style factors such as smoking or diet is controversial. Lately high carbohydrate diet and dairy products have been implicated as aggravating factors. Mild acne normally responds to topical monotherapy, in moderate disease combination of two synergistically acting substances (e.g. benzoyl peroxid plus antibiotic, benzoyl peroxid plus retinoid, retinoid plus antibiotic, benzoyl peroxid plus azelaic acid) will improve clinical response. Retinoids and/or benzoylperoxid have been shown to be effective in maintenance therapy. In patients with severe disease or high risk of scarring systemic therapy with antibiotics, oral contraceptives with antiandrogenic properties and in particularly isotretinoin as most effective acne treatment should be considered early to avoid physical and emotional scars.

Uso da limeciclina associada com o peróxido de benzoíla no tratamento da hipomelanose macular progressiva: um estudo prospectivo / The use of lymecycline and benzoyl peroxide for the treatment of progressive macular hypomelanosis: a prospective study

A hipomelanose macular progressiva é uma dermatose de etiopatogenia pouco conhecida. A participação do Propionibacterium acnes e a resposta ao tratamento com medicamentos com atividade para essa bactéria têm sido sugeridas. Relata-se uma série de casos de 13 pacientes com hipomelanose macular progressiva tratados com limeciclina e peróxido de benzoíla durante três meses, que apresentaram excelente resposta ao tratamento e nele se mantêm durante o período de seguimento do estudo.

Progressive macular hypomelanosis is a dermatosis of uncertain etiology. The participation of Propionibacterium acnes has been suggested in view of the response achieved following therapy with drugs that are active against this bacterium. This report describes a series of thirteen patients with progressive macular hypomelanosis who were treated with an association of lymecycline and benzoyl peroxide over a three-month period. Response to treatment was excellent and the positive results were maintained during the entire follow up period.

[Association between allergy to benzoyl peroxide, vitiligo and implantation of a cemented total knee joint prosthesis: Is there a connection?]. / Assoziation zwischen Benzoylperoxidallergie, Vitiligo und Implantation einer zementierten Knieprothese: Ein Zusammenhang?

Allergies against bone cement or bone cement components have been well-described. We report on a 63-year-old patient who presented with progressive vitiligo all over the body after implantation of a cemented total knee replacement. A dermatological examination was performed and an allergy to benzoyl peroxide was found. A low-grade infection was diagnosed 5 months after implantation of the total knee replacement and the prosthesis was replaced with a cement spacer. After treating the infection of the knee replacement non-cemented arthrodesis of the knee was performed. In cases of new, unknown skin efflorescence, urticaria and periprosthetic loosening of cemented joint replacement, the differential diagnosis should include not only infections but also possible allergies against bone-cement and components such as benzoyl peroxide or metal components.