The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study.

BACKGROUND: Topical combination therapy, such as that with fixed-dose clindamycin/benzoyl peroxide (BPO) or adapalene/BPO, is the recommended first-line approach for the treatment of facial acne. AIMS: To compare the tolerability of clindamycin 1%/BPO 5% gel vs. adapalene 0.1% BPO 2.5% gel for the first 2 weeks of treatment in patients with facial acne. PATIENTS/METHODS: Using a randomized, single-blind, split-face method, 48 patients with acne received both clindamycin/BPO and adapalene/BPO once daily for 2 weeks. The primary endpoint was investigator-assessed tolerability. Treatment efficacy, patient-assessed tolerability and satisfaction, and safety were also investigated. RESULTS: Forty-five patients completed treatment. Investigator-rated scores for erythema, dryness, and peeling were significantly higher with adapalene/BPO than clindamycin/BPO. Patients rated clindamycin/BPO as significantly more tolerable than adapalene/BPO for redness, dryness, burning, itching, and scaling. Investigator Static Global Assessment scores and lesion counts improved with both products, with no significant difference between treatments. Patients' Global Change Assessment showed a statistically significant difference in favor of clindamycin/BPO at week 1, but not week 2. Overall, >80% of patients were "satisfied" or "very satisfied" with treatment at week 2, but 63% of patients stated that they preferred clindamycin/BPO. Both products were well tolerated, with no serious adverse events (AEs), but a post hoc analysis indicated that treatment-related AEs, including irritation, dryness and erythema, were significantly less common with clindamycin/BPO. CONCLUSIONS: Clindamycin/BPO had a better tolerability profile than adapalene/BPO during 2 weeks of split-face treatment. Treatment satisfaction was highest with clindamycin/BPO.

Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study.

BACKGROUND: Topical fixed-combination therapy containing 1% clindamycin as 1.2% clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective treatment for acne vulgaris (acne). OBJECTIVES: To demonstrate that the combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and vehicle gel. METHODS: A total of 1,319 patients with acne, aged 12 years or older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy was evaluated using a six-point Investigator's Static Global Assessment (ISGA) and Subject's Global Assessment (SGA) of acne severity and lesion counts (inflammatory, non-inflammatory, and total). Safety assessments included skin tolerability and adverse events (AEs). RESULTS: A greater proportion of subjects who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% and vehicle alone in the absolute reduction from baseline to week 12 in all three lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior to BPO 3% alone in the absolute reduction from baseline to week 12 in inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of product-related AEs was low and similar in all study groups (1% with CLNP 1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local tolerability assessments showed similar minimal changes from baseline to week 12 in all study groups. CONCLUSION: CLNP 1.2%-BPO 3% gel provides superior efficacy to improve ISGA score and reduce inflammatory and total lesion counts compared with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while maintaining a highly favorable safety and tolerability profile similar to BPO 3% alone.

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.

A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne.

A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% recently has been developed for the treatment of acne vulgaris. In this multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled study conducted at 60 centers in the United States, Puerto Rico, and Canada, we assessed the efficacy and safety of adapalene-BPO combination gel in comparison with adapalene and BPO monotherapies as well as the gel vehicle. Participants with moderate facial acne vulgaris (rated 3 on the 5-point investigator global assessment of acne severity scale) were recruited and randomized to receive once-daily treatment with adapalene-BPO combination gel, adapalene monotherapy, BPO monotherapy, or gel vehicle for 12 weeks. They were assessed for success rate (the percentage of participants with investigator global assessment of acne severity rated clear or almost clear) and percentage change in inflammatory lesion (IL), noninflammatory lesion (NIL), and total lesion counts. Of the 1668 participants enrolled, 1429 (85.7%) completed the study. At study end point, adapalene-BPO combination gel showed a significantly higher success rate (P < or = .006) and a greater percentage reduction in all acne lesion counts (P < or = .017) compared with the other treatment groups. A significant early treatment effect of adapalene-BPO combination gel at week 1 compared with adapalene monotherapy and vehicle also was observed for all lesion count reductions (P<.001). The safety of adapalene-BPO combination gel was comparable with adapalene and BPO monotherapies and vehicle. In a large clinical trial, the adapalene-BPO fixed-dose combination gel has shown superiority in efficacy compared with adapalene and BPO monotherapies and vehicle, with an early onset of efficacy and a good safety profile.

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

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% 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% 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.

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

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 (AU)