Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, Noninterventional Study

<b><i>Introduction:</i></b> Daily parallel application of adapalene and nadifloxacin has been determined to be effective and well tolerated in patients with acne vulgaris in randomized, controlled clinical studies. Here, the authors report the results from a large, prospective, uncontrolled, multicentric, noninterventional study under real-life conditions in Germany. The effect of treatment on acne severity, safety, and, for the first time, health-related quality of life (HRQoL) was investigated. <b><i>Methods:</i></b> Of the 292 patients (safety collective: 231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% cream for the defined minimum of 28 days. Patients were evaluated for acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety. <b><i>Results:</i></b> After the median treatment duration of 37 and 38 days (adults and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, respectively, exhibited a sustained decrease in acne severity. The LRAG decreased by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children’s Dermatology Life Quality Index). Female adults were more impaired in terms of HRQoL compared to male adults. The 2 best overall efficacy ratings were provided by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and adolescent cases, respectively. The treatment was well tolerated, as reflected in the low number of 9 mild adverse events (AEs), all of which resolved without treatment. However, 4 patients terminated the study prematurely due to AEs. <b><i>Conclusion:</i></b> In this study, the parallel use of adapalene and nadifloxacin for at least 5 weeks resulted in a rapid improvement in acne severity, an increase in HRQoL, and a good safety profile. Therefore, it represents a promising treatment option that offers the possibility of flexible therapy adjustment.

Pustulosis palmoplantaris: Langfriste Kontrolle im Blick

Im Rahmen der sog. 2PRECISE-Studie, einer multizentrischen, randomisierten, doppelblinden Phase 3b Parallel-Studie, wurden Patienten mit mittelschwerer bis schwerer PPP (palmoplantarer Psoriasis Area and Severity Index (PPPASI) ≥12 und Dermatology Life Quality Index (DLQI) ≥10) über 52 Wochen mit Secukinumab bzw. Placebo behandelt. Der primäre Endpunkt der Studie war die Bestimmung der Rate der Patienten mit einem ppPASI75 unter Therapie mit Secukinumab in Woche 16 gegenüber Placebo. Es wurde ein Signifikanzlevel von 2,5% zugrunde gelegt. 79 Patienten erhielten Secukinumab in einer Dosierung von 300mg und 80 Patienten wurden mittels Secukinumab 150mg behandelt. 78 Patienten wurden der Placebo-Gruppe zugeordnet. Ab Woche 16 erhielten 27 Patienten aus der Placebo-Gruppe 150mg Secukinumab und 28 Patienten 300mg Secukinumab. 10 Patienten hatten auf Placebo angesprochen. In Woche 16 erreichten 26,6% der mit 300mg Secukinumab behandelten Patienten und 17,5% der Patienten unter 150mg Secukinumab einen ppPASI75 im Vergleich zu 14,1% der mit Placebo behandelten Patienten (P = 0,0411). Der primäre Endpunkt wurde nicht erreicht, jedoch ergab sich eine Odds Ratio (OR) von 2,62 (95% Konfidenzintervall, 1,04–6,60) zugunsten von 300mg Secukinumab gegenüber Placebo. In Woche 52 wiesen 41,8% der mit 300mg Secukinumab behandelten Patienten und 35,0% der Patienten unter Secukinumab 150mg einen ppPASI75 auf. Das klinische Ansprechen der Patienten, die auch unter einer Plaque Psoriasis litten, war besser als das der Patienten mit einer reinen PPP. Die Lebensqualitätsverbesserung gemessen mit dem DLQI war unter 300mg Secukinumab deutlich besser als unter Placebo. In Woche 16 erreichten 13% der Patienten unter Secukinumab 300mg einen DLQI von 0 oder 1, während es unter Placebo nur 4,3% der Patienten waren. Es wurden in der Studie keine unerwarteten unerwünschten Ereignisse beobachtet.

Dermatology life quality index in patients of acne vulgaris presenting to a tertiary care hospital: an observational study

<p class="abstract"><strong>Background: </strong>Acne vulgaris is a common, chronic disorder resulting from the inflammation of pilosebaceous unit, present with clinically various forms. It is usually prevalent in adolescent may persist in adulthood. This study was conducted to evaluate the quality of life (QoL) in patients suffering from acne vulgaris.</p><p class="abstract"><strong>Methods:</strong> Hospital based cross sectional study was conducted in 60 patients. Dermatology life quality index (DLQI) questionnaire was used to observe the effect of acne among patients.</p><p class="abstract"><strong>Results: </strong>Total numbers of patients enrolled were 60 (43 females,17 males). The mean age was 24.85±5.63 years. Maximum patients were of the age group 26-30 years (22 patients; 36%) and least were of 31-36 age group. Out of 60 patients, 29 patients had grade II acne followed by 20 with grade I acne, grade III acne was present in 11 patients. Most of the patients 31 (52%) were having “moderate impact” on quality of life followed by 23 (38%) with “small impact” on QOL. There was a significant positive correlation between grade of acne and DLQI (Pearson correlation=0.753, p=0.00).</p><p class="abstract"><strong>Conclusions: </strong>Our study showed significant impairment of QoL in acne patients. DLQI increases with increase in severity of acne. Treatment of acne should not be guided only by the clinical grade of acne, but take into consideration the psychosocial impact the condition has on the patient. Adequate counselling along with early treatment of acne vulgaris is essential in order to reduce the disease related psychosocial sequelae and increase treatment efficacy.</p>

Psychometric characteristics of DLQI-BRA and Skindex-16 to measure the impact of dermatological diseases on quality of life in Brazilian patients

Objective To compare the psychometric performance of the Dermatology Life Quality Index (DLQI-BRA) and Skindex-16 to assess quality of life (QoL) in Brazilian patients with dermatological diseases. Methods This was a cross-sectional study carried out in a dermatology outpatient clinic of the São Paulo State University, with 188 patients with dermatological diseases. QoL was evaluated using the Dermatology Life Quality Index (DLQI-BRA) and Skindex-16. Cronbach’s alpha and Intraclass Correlation for Perfect Concordance (ICC) were used to analyse the reliability and temporal stability, respectively. Results A positive correlation was found between the total Skindex-16 score and DLQI-BRA (0.75). Both instruments showed a significant (p< 0.01) reduction in their scores at the second assessment, demonstrating that they were sensitive in detecting changes in responsiveness in cases where there was a clinical change. Cronbach alpha coefficients for the instruments showed satisfactory performance (>0,7), but Skindex-16 displayed the highest Cronbach alpha (0.94; CI = 0.93–0.95). Conclusion Both instruments tested showed a good psychometric performance assessing QoL in patients with skin dermatoses. The instruments displayed reliability and temporal stability as well as responsiveness.

TRANSORAL THYROIDECTOMY AND PARATHYROIDECTOMY: SERIES OF CASES

Objective. To present the results of the author’s own series of transoral operations in patients with pathology of the thyroid and parathyroid glands. Methods. Transoral surgery was performed in women (n=20) and (n=1) man. All patients were operated on for the primary disease and met the selection criteria based on ultrasound and cytological examinations, hormonal levels, and somatic status. Indications for surgery were: nodular goiter in 17 cases, diffuse toxic goiter - in 2 cases, parathyroid adenoma - in 2 cases. The surgical technique included a three-port approach in the lower fornix of the vestibule of the mouth and a gas technique for maintaining the working cavity. Standard laparoscopic instruments and an energy based ultrasonic device were used for the operation. In the postoperative period, patients underwent a test for subjective assessment of the aesthetic result of the operation using the survey of thedermatology life quality index. Results. Thyroidectomy was performed in 4 patients, hemithyroidectomy - in 15 patients and parathyroidectomy - in 2 patients. In one patient, transoralparathyroidectomy was performed as a part of a simultaneous operation for multiple endocrine neoplasia type 1 syndrome. Papillary cancer T1N0M0 was verified in two patients after surgery. The mean operation time was 196.1 min (range 110 - 300 min). Average blood loss - 3 9.5 ml (range 10 - 300 ml). The nineth operation required the conversion due to severebleeding. In one case, the temporary recurrent laryngeal nerve(RLN)injury was reported, in one case - hematoma. After surgery, the median and average values of thedermatology life quality index were 1 (IQR 0-4) and 2.05, respectively, which indicates an insignificant effect on the quality of life. Conclusion. Transoral endoscopic surgery on the thyroid and parathyroid glands would be thepromising optimal choice in patients to avoid scarring on the neck.

Evaluation of Reliability and Validity of Persian Version of Children’s Dermatology Life Quality Index (CDLQI) Questionnaire and Practical Use

Background: Atopic dermatitis is a common skin disease in children. Severe pruritus and eczematous lesions may interfere with the quality of life of the patients. Objectives: This study was designed to assess the validity and reliability of the Persian version of the children’s dermatology life quality index questionnaire. Methods: After obtaining final acceptance by the first developers of the questionnaire for developing a Persian version, it was distributed to 100 children affected with atopic dermatitis aged 5 to 15 years. We analyzed data by SPSS18. Then, we evaluated the validity and reliability of the questionnaire by Kaiser criterion and Cronbach’s alpha. Results: Questions number 1 (itching) and 6 (sports activities) achieved the highest and the lowest scores, respectively. Cronbach’s alpha was assessed as 0.87, demonstrating good reliability. Inter-item correlation coefficients ranged from 0.24 to 0.69. A one-factor structure was achieved by Kaiser criterion and scree plot. Conclusions: Our study demonstrated good reliability and validity of the Persian version of the children’s dermatology Life Quality Index Questionnaire. There was a significant positive relationship between the severity of the disease and the score of quality of life. However, there was no relationship between the quality of life and the demographic features of the participants.