Dr. August Wolff GmbH & Co. KG Arzneimittel

The Hyperhidrosis Quality of Life Index (HidroQoL©) is a well-developed patient-reported outcome measure assessing the quality of life impacts in hyperhidrosis (HH), which has proven very good measurement properties, such as structural validity and internal consistency.

We aimed to investigate responsiveness over time and estimate values for meaningful within-person change (MWPC) towards symptom improvement for different measurement timepoints (4 and 12 weeks), extending the existing validity evidence in patients with primary axillary HH.

Data (from a phase IIIb clinical trial) were collected at baseline, and at weeks 4, 8, 12, 28, 52 and 72. For the assessment of responsiveness, HidroQoL change scores were correlated with corresponding change scores of the Hyperhidrosis Disease Severity Scale (HDSS), the Dermatology Life Quality Index (DLQI) and gravimetric sweat production based on a priori formulated hypotheses. Furthermore, we tested whether the different HDSS change score groups differed significantly from each other over time and whether the HidroQoL was sensitive towards these group differences over time. This was extended by the calculation of matched-pair tests and effect sizes to test significance for each change group separately. For the estimation of MWPC thresholds towards symptom improvement, different anchor-based and integrated approaches were used.

In total, the sample comprised 357 patients with primary axillary HH. For the assessment of responsiveness, five out of 14 a priori hypotheses regarding the correlation of the change scores could be confirmed, whereas the rejected hypotheses differed only marginally from the expected values. Furthermore, regarding responsiveness, the HidroQoL showed sensitivity towards symptom improvement at each measurement timepoint. Effect sizes were large as expected (d ≥ 0.806). MWPC thresholds towards symptom improvement were proposed for two measurement timepoints: 5 (week 4) and 6 (week 12). Increasing MWPC values over time were observed.

This study extends the evidence for the longitudinal validity of the HidroQoL© up to 72 weeks and proposed MWPC thresholds for different time intervals (4 and 12 weeks) after baseline, aiding interpretability. Results concur with findings from previous validation studies.

In the first part of our study, we therefore employed various cellular and mol. techniques and measured the effects of DMG-Na in vitro on primary human dermal microvascular endothelial cells(HDMECs).First, we measured the effects of DMG-Na on the [Ca2+]i of HDMECs.As detected by fluo-4acetoxymethyl-based microfluorimetry, in normal (1.8 mM) calcium ion-containing medium, DMG-Na elevated the [Ca2+]i of HDMECs in a dose-dependent manner; in this study, 0.02 and 0.05% of DMG-Na exerted statistically significant responses (P < .0001 in both cases) compared with the control.

The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause.

Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial.

During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied.

A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred.

Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active.

gov identifier NCT05211505.