The parallel use of adapalene and nadifloxacin for at least 5 weeks was associated with rapid improvement in acne severity, an increase in health-related quality of life (HRQoL), and a good safety profile among patients with mild to moderate inflammatory acne vulgaris, according to study findings published in Biomedicine Hub.
Researchers reported their efficacy and safety findings in patients with acne who received adapalene 0.1% cream or gel and nadifloxacin 1% cream in clinical practices in Germany.
Eligible patients had a confirmed diagnosis of mild to moderate inflammatory acne vulgaris in the facial area that corresponded with grade 4 or higher per the Leeds Revised Acne Grading (LRAG) system. Data were collected at baseline and final examination, and only patients who were treated for at least 28 days were included in the efficacy analysis.
HRQoL in the adult patients was assessed with use of the German version of the Dermatology Life Quality Index, and HRQoL in the adolescent group was assessed with the Children’s Dermatology Life Quality Index.
The efficacy cohort included 213 adults and 60 adolescents, and the safety collective included 231 adults and 61 adolescents. The adult efficacy group (148 women) had a median age of 22 years (range, 17-54 years) and a median duration of acne symptoms of 15 months. The adolescent group included 60 patients (33 boys) aged 14 to 16 years with an acne duration of 1 to 48 months.
The adult patients had a marked improvement in acne severity, acne-related symptoms, and HRQoL after a median of 37 days of treatment with adapalene 0.1% and nadifloxacin 1%, with 93.4% having improvement in severity of facial acne symptoms. Improvement of at least 3 LRAG scores was observed in 59 patients (43women). Among 162 patients (113women) for whom HRQoL was assessed, improvement was observed in 110 patients (67.9%), no change occurred in 27 patients (16.7%), and worsening occurred in 25 patients (15.4%).
Among the adolescent patients, LRAG scores improved after treatment in 51 patients (85.0%; 95% CI, 73.4, 92.9) and were unchanged in 9 patients (15.0%). HRQoL improved in 63.5% (n = 33) of the adolescent patients, was unchanged in 21.1% (n = 11), and worsened in 15.4% (n = 8).
Adverse event (AE) data were available for 229 adults, in whom 8 mild AEs were reported in 4 patients (1.8%; CI, 0.5%, 4.4%), all of which were facial skin irritations. No serious AEs were reported.
Study limitations include the absence of a control group and lack of statistical power for certain analysis. A further limitation may be the short observation period.
“Our results suggest that the parallel application of adapalene and nadifloxacin is a promising treatment option in adults and adolescents with acne vulgaris, with a rapid onset of action and considerable improvement of acne symptoms and HRQoL after at least 5 weeks of treatment,” concluded the investigators.
Disclosure: This study was sponsored by Dr. Pfleger Arzneimittel GmbH. Some of the study authors declared affiliations with a pharmaceutical company. Please see the original reference for a full list of disclosures.
Neumeistera C, Bödekerb RH, Schwantesa U, Borelli C. Impact of parallel topical treatment with nadifloxacin and adapalene on acne vulgaris severity and quality of life: a prospective, uncontrolled, multicentric, noninterventional study. Biomed Hub. 2021;6(3):158-171. doi:10.1159/000520447