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.

Efficacy of probiotic-derived lotion from Lactobacillus paracasei MSMC 39-1 in mild to moderate acne vulgaris, randomized controlled trial.

BACKGROUND: Probiotics provide benefits for reducing acne. Previous studies showed an anti-inflammatory effect of Lactobacillus paracasei. However, the clinical evidence of topical probiotic lotion and acne treatment is still lacking. OBJECTIVE: To evaluate the efficacy and safety of probiotic-derived lotion compared with 2.5% benzoyl peroxide in the treatment of mild-to-moderate acne vulgaris. METHODS: Topical probiotic-derived lotion was formulated from cell-free supernatant of L. paracasei MSMC 39-1. In vitro study showed the ability of the supernatant to inhibit both antibiotic-resistance and-susceptibility strains of C. acnes and inhibit tumor necrosis factor-α. The patients with mild-to-moderate acne vulgaris on the face were randomized to receive topical probiotic-derived lotion or 2.5% benzoyl peroxide. Acne lesion counts, erythema index, and side effects were assessed after 2 and 4 weeks of treatment. RESULTS: One hundred and four acne vulgaris patients were enrolled. After four weeks of treatment, the inflammatory acne lesion counts and erythema index significantly decreased compared with the baseline in both the probiotic-derived lotion group and 2.5% benzoyl peroxide group (p < 0.001 in both groups) without statistically significant difference between the two groups (p > 0.05). However, the comedones were not affected in both groups. Four patients (7.69%) treated with probiotic-derived lotion and 14 patients (26.92%) treated with 2.5% benzoyl peroxide reported treatment-associated side effects. CONCLUSION: Probiotic-derived lotion is safe and effective for treating mild to moderate acne vulgaris, a comparable outcome with 2.5% benzoyl peroxide. It could be an alternative treatment of acne with more minor side effects.

Randomized, controlled trial testing the effectiveness and safety of 2.5% and 5% benzoyl peroxide for the treatment of pitted keratolysis.

BACKGROUND: The appropriate dosage and duration of topical benzoyl peroxide gel (BP) treatment of pitted keratolysis (PK) is controversial. OBJECTIVE: To compare the effectiveness and safety of topical 2.5% and 5% BP for the treatment of PK. MATERIALS AND METHODS: This randomized, controlled trial was conducted at Chumpol Naval Rating School, Chonburi, Thailand. Naval rating cadets with PK were randomly assigned to either a 2.5% or a 5% BP group and were requested to apply the related medication on each sole once daily, for 2 weeks. RESULTS: All 42 and 47 participants who were treated with 2.5% and 5% BP, respectively, were included in the later analysis. Self-evaluation of the foot odor level using a visual analog scale (VAS) showed significant decreases for both groups (p<.001). The pitted lesions were evaluated by dermatologists and found to have improved in the 2.5% and 5% BP groups (69.0% versus 63.8%, respectively; p=.457). Side effects did not statistically differ between the two groups (p>.05). CONCLUSIONS: Either 2.5% or 5% BP can be used for the treatment of PK and foot malodor. Due to the similarities in their efficacies and side effects, the use of 2.5% BP may be preferable.

A case series of cementless revision total knee arthroplasty in patients with benzoyl peroxide allergy.

PURPOSE: The contact allergens nickel, cobalt, and chromium are often discussed as possible triggers of allergic reactions to orthopedic implants. Additionally, acrylates and polymerization additives in bone cement (e.g., benzoyl peroxide (BPO)) have been implicated as triggers of eczema, wound healing disorders, and aseptic implant loosening. We report about six patients with aseptic loosening after total knee arthroplasty (TKA), who underwent revision surgery after testing positive for BPO hypersensitivity. METHODS: After clarification of possible other causes of implant failure, epicutaneous testing had been performed and the implants were replaced in a two-stage procedure with cementless, diaphyseal anchoring, hypoallergenic (TiNb-coated) revision endoprostheses. RESULTS: Epicutaneous testing revealed a BPO allergy in all six patients and an additional nickel allergy in three of the six patients. There was no histopathological or microbiological evidence for a periprosthetic infection. The clinical follow-up showed a low level of pain with good function, a stable knee joint, and proper implant position. The Knee Society Score (KSS) with its subscales Knee Score and Functional Score improved post-operatively from 43 to 70 points and from 47.5 to 68.3 points, respectively. Two implant-specific complications occurred: femoral stress shielding two years post-operatively with no further need for action and aseptic loosening of the tibial stem with the need of revision three years post-operatively. CONCLUSIONS: The regression of complaints after replacement with cementless and nickel-free revision implants suggests allergic implant intolerance. Implantation of a cementless, hypoallergenic endoprosthesis might, therefore, be a surgical treatment strategy in patients with evidence of allergies.

A Case of a Paediatric Patient With Allergic Contact Dermatitis to Benzoyl Peroxide.

Allergic contact dermatitis to benzoyl peroxide can occur in up to 6.5% of those with a history of exposure to this potential allergen. Conversely, irritant contact dermatitis is very common with benzoyl peroxide and can be differentiated from allergic contact dermatitis based on the patient's history and clinical signs and symptoms. We present a case of a paediatric patient with patch test-confirmed severe allergic contact dermatitis to benzoyl peroxide requiring hospitalisation and systemic treatment.

Allergic Contact Dermatitis to Benzoyl Peroxide Resembling Impetigo.

A 17-year-old boy presented with recurring severe dermatitis of the face of 5-months duration that resembled impetigo. He had been treated with several courses of antibiotics without improvement. Biopsy showed changes consistent with allergic contact dermatitis and patch testing later revealed sensitization to benzoyl peroxide, which the patient had been using for the treatment of acne vulgaris.

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.

Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule.

We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products.

Estudo clínico, prospectivo, aberto, randomizado e comparativo para avaliar a segurança e a eficácia da luz azul versus peróxido de benzoíla 5 por cento no tratamento da acne inflamatória graus II e III / A prospective, randomized, open and comparative study to evaluate the safety and efficacy of blue light treatment versus a topical benzoyl peroxide 5 percent formulation in patients with acne grade II and III

FUNDAMENTOS: Muitos pacientes relatam melhora da acne com a exposição à luz solar, e vários estudos demonstram que a luz azul é efetiva no tratamento da acne. OBJETIVOS: Verificar a segurança e a eficácia da luz azul (espectro eletromagnético de 407 a 420 nm) no tratamento da acne inflamatória graus II e III, comparada à terapêutica tópica com peróxido de benzoíla a 5 por cento. MÉTODOS: O estudo avaliou 60 pacientes em cinco visitas: uma de seleção, uma com 7, 14 e 28 dias de tratamento e uma última de seguimento, 14 dias após o término do tratamento. Trinta foram randomizados para luz azul (oito sessões, duas vezes por semana), e outros 30, para peróxido de benzoíla a 5 por cento, duas vezes ao dia, diariamente. A avaliação foi por meio da contagem das lesões e fotografias. RESULTADOS: A redução no número médio de lesões foi semelhante com os dois tratamentos, independente do tipo de lesão (p 0,05), porém o tratamento com a luz azul apresentou menos efeitos colaterais. CONCLUSÕES: A luz azul foi um tratamento tão eficaz quanto o peróxido de benzoíla a 5 por cento para o tratamento da acne graus II e III, mas com menos efeitos adversos.

BACKGROUND: Many acne patients improve after exposure to sunlight and there are many reports about the efficacy of blue light phototherapy on acne lesions. OBJECTIVES - The purpose of this study was to evaluate efficacy and safety of blue light treatment versus topical benzoyl peroxide 5 percent formulation in patients with acne grades II and III. METHODS - Sixty volunteers with facial acne were included and evaluated in 5 visits: the first one for screening, another 3 held on days 7, 14 and 28 of treatment, and the last one after 14 days of the end of treatment. Thirty of them were irradiated with Blue Light (8 times, twice a week) and the other thirty were treated with topical Benzoyl Peroxide 5 percent formulation, auto-applied twice a day, every day. We assessed the severity of acne by counting the lesions and analyzing the photographs. RESULTS - The improvement achieved by the blue light was the same as the one with benzoyl peroxide, regardless of the type of lesion (p 0.05). Otherwise, the side effects were less frequent in the group treated with blue light. CONCLUSIONS - Blue light irradiation was as effective as Benzoyl Peroxide in acne treatment grades II and III but there were fewer side effects.

Emerging drugs for acne.

Acne vulgaris is a common skin disorder that affects most individuals at some point in their lives. It may result in significant morbidity, including cutaneous scarring and psychological impairment. Current treatments include topical retinoids, benzoyl peroxide, topical and systemic antibiotics, and systemic isotretinoin. There are growing concerns of rising antibiotic resistance, significant side effects of isotretinoin therapy, and lack of safe and effective treatment for pregnant females. Recent advances in the pathogenesis of acne have led to a greater understanding of the underlying inflammatory mechanisms and the role the Propionibacterium acnes and biofilms. This has led to the development of new therapeutic targets. This article reviews emerging treatments of acne, including topical picolinic acid, topical antibiotic dapsone, systemic zinc salts, oral antibiotic lymecycline, new formulations of and synergistic combinations of benzoyl peroxide, photodynamic therapy with topical photosensitizers and potential acne vaccines.

[Allergy to bone cement components]. / Allergie auf Knochenzementbestandteile.

Intolerance reactions to endoprostheses may lead to allergological diagnostics, which focus mainly on metal allergy. However, bone cement may also contain potential allergens, e.g. acrylates and additives such as benzoyl peroxide (BPO), N,N-dimethyl-p-toluidine, hydroquinone, and antibiotics (particularly gentamicin). In the Munich implant allergy clinic, we found that 28 of 113 patients (24.8%) with cemented prostheses had contact allergies to bone cement components, mostly to gentamicin (16.8%) and BPO (8.0%). The clinical significance of test results cannot always be shown, but we still recommend including bone cement components in the allergological diagnostics of suspected hypersensitivity reactions to arthroplasty.

Acné: nuevas tendencias / Acne: new tendencies

La acné es una enfermedad muy frecuente que aparece alrededor de la pubertad y se caracteriza por su polimorfismo lesional y su cronicidad. Se la divide en grados de severidad y según los mismos se determina la terapéutica adecuada. Tiene un alto impacto psicosocial en quienes la padecen por lo cual es muy importante el vínculo que se establece entre el paciente y su médico, lo cual redundará en una buena aceptación del tratamiento y una mejor respuesta por parte del paciente. En los últimos años se ha avanzado en el conocimiento de su etiopatogenia, lo cual permitió un entendimiento más profundo de la enfermedad. La tendencia actual es la de combinar diferentes drogas que tengan influencia sobre diferentes etiopatogénicos de la acné. Se ha comprobado que de este modo la respuesta es más rápida y el tratamiento menos tóxico

Effect of benzoyl peroxide on antioxidant status, NF-kappaB activity and interleukin-1alpha gene expression in human keratinocytes.

Benzoyl peroxide (BP) is used as a topical treatment for acne. Besides its anti-bacterial activity, the exact molecular mechanisms underlying its mode of action are not fully understood. In the current study, the effects of BP on cell viability, antioxidant status and, IL-1 and IL-8 gene expression were investigated in HaCaT keratinocytes. Keratinocytes incubated for 24 h with BP exhibited a dose-dependent cytotoxicity at concentrations above 250 microM. Furthermore, in the presence of 300 microM BP about 50% of the cellular vitamin E was depleted within the first 30 min. The intracellular ratio of oxidized to reduced glutathione (GSSG/GSH) was increased significantly starting 6 h after BP treatments indicating that BP reacts rapidly with targets in the cell membrane and more slowly with those in the cytosol. NF-kappaB transactivation was not significantly affected by BP. However, BP treatment of HaCaT keratinocytes resulted in a dose-dependent increase in IL-1alpha gene expression whereas no changes in IL-8 mRNA levels were observed. These results demonstrate that BP induces an inflammatory reaction mediated by oxidative stress by a pathway independent of the redox-sensitive transcription factor NF-kappaB.