26 research outputs found

    Efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% topical gel in moderate and severe acne vulgaris

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    This study compared the efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel vs vehicle in subjects with moderate and severe acne (overall population [OP]), and in a subpopulation of the OP (severe acne subjects only) (severe population [SP]). The study also compared 0.3% A/BPO vs adapalene 0.1%/benzoyl peroxide 2.5% (0.1% A/BPO) topical gel in the SP. This multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study included a total of 503 subjects. Subjects were randomized to apply 0.3% A/BPO (n = 217), 0.1% A/BPO (n = 217) or vehicle (n = 69) once daily for 12 weeks. The OP included subjects with moderate (investigator global assessment [IGA] = 3) and severe (IGA = 4) acne, while the SP consisted only of subjects with severe disease (IGA = 4). Coprimary efficacy endpoints included success rate (at least 2-grade improvement on IGA) and change in inflammatory (IN) and noninflammatory (NIN) lesion count from baseline to week 12. In the OP, 0.3% A/BPO was superior to vehicle in success rate (33.7% vs 11.0%), and changes in IN (-27.0 vs -14.4) and NIN lesion counts (-40.1 vs -18.4), as well as percent changes in IN (-68.7% vs -39.2%) and NIN lesion counts (-68.3% vs -37.3%, respectively; all P \u3c .001). Similarly, in the SP, 0.3% A/BPO was superior to vehicle in success rate (31.9% vs 11.8%; P = .029), and changes in IN (-35.1 vs -15.4) and NIN lesion counts (-45.6 vs -17.2), as well as percent changes in IN (-74.4% vs -33.0%) and NIN lesion counts (-72.0% vs -30.7%, respectively; all P \u3c .001). Of note, 0.3% A/BPO showed nonstatistically significant but positive numerical differences over 0.1% A/BPO in the SP of 11.4% (95% confidence interval [CI]: -0.5%, 23.2%) in success rate, and -3.25 [CI: -7.15, 0.64] and -2.51 [CI: -8.08, 3.06] for changes in IN and NIN lesion counts. In terms of safety, 0.3% A/BPO was well tolerated, with a similar local tolerability profile to that of 0.1% A/BPO. Treatment-related adverse events (AEs) (15 AEs in 12 subjects [5.5%] vs 2 AEs in 1 subject [0.5%], respectively) were mild to moderate in severity. Only 1 subject (0.2%) in the 0.3% A/BPO group discontinued treatment due to an AE (atopic dermatitis flare) and no serious AEs were reported. The 0.3% A/BPO topical gel showed superior efficacy to vehicle in the general population, with greater efficacy shown in subjects with severe acne. The safety profile of 0.3% A/BPO was acceptable and comparable to that observed for 0.1% A/BPO

    Detection of bacterial pathogens in clade E head lice collected from Niger's refugees in Algeria

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    International audienceBackground: Head lice, Pediculus humanus capitis, are obligate blood-sucking parasites. Phylogenetically, they occur in five divergent mitochondrial clades (A, D, B, C and E), each having a particular geographical distribution. Recent studies have revealed that head lice, as is the case of body lice, can act as a vector for louse-borne diseases. Here, we aimed to study the genetic diversity of head lice collected from Niger's refugees (migrant population) arriving in Algeria, northern Africa, and to look for louse-borne pathogens. Comparative head lice samples collected from indigenous population of schoolchildren (non-immigrant) were also analyzed to frame the study. Results: In this study, 37 head lice samples were collected from 31 Nigerien refugees, as well as 45 head lice from 27 schoolchildren. The collection was established in three localities of eastern Algiers, north Algeria. Quantitative real-time PCR screening of pathogens bacteria and the genetic characterisation of the head lice satut were performed. Through amplification and sequencing of the cytb gene, results showed that all head lice of Nigerien refugees 37/82 (45.12%) belonged to clade E with the presence of four new haplotypes, while, of the 45 head lice of schoolchildren, 34/82 lice (41.46%) belonged to clade A and 11/82 (13.41%) belonged to clade B. Our study is the first to report the existence of clade E haplogroup in Nigerien head lice. DNA of Coxiella burnetii was detected in 3/37 (8.10%) of the head lice collected from 3 of the 31 (9.67%) migrant population. We also revealed the presence of Acinetobacter DNA in 20/37 (54.05%) of head lice collected from 25/31 (80.64%) of the Nigerien refugees, and in 25/45 (55.55%) head lice collected from 15/27 (55.55%) schoolchildren. All positive Nigerien-head lice for Acinetobacter spp. were identified as A. baumannii, while positive schoolchildren-head lice were identified as A. johnsonii 15/25 (60%), A. variabilis 8/25 (32%) and A. baumannii 2/25 (8%). Conclusions: Based on these findings from head lice collected on migrant and non-migrant population, our results show, for the first time, that head lice from Niger belong to haplogroup E, and confirm that the clade E had a west African distribution. We also detected, for the first time, the presence of C. burnetii and A. baumannii in these Nigerien head lice. Nevertheless, further studies are needed to determine whether the head lice can transmit these pathogenic bacteria from one person to another
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