PMID- 37605375
OWN - NLM
STAT- MEDLINE
DCOM- 20231106
LR  - 20231106
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Linking)
VI  - 50
IP  - 11
DP  - 2023 Nov
TI  - Long-term evaluation of the safety and efficacy of a novel 20% oxybutynin 
      hydrochloride lotion for primary palmar hyperhidrosis: An open-label extension 
      study.
PG  - 1459-1472
LID - 10.1111/1346-8138.16922 [doi]
AB  - The long-term safety and efficacy of 52-week application of oxybutynin 
      hydrochloride 20% lotion (20% OL) for the treatment of primary palmar 
      hyperhidrosis (PPHH) in Japanese patients aged >/=12 years were evaluated in an 
      open-label extension (OLE) of a 4-week, randomized, double-blind (DB) study. The 
      OLE included 114 patients who completed the DB study and wished to continue 
      treatment and 12 new patients. In the safety analysis population (125 patients), 
      the incidence of adverse events (AEs) and adverse drug reactions (ADRs) was 79.2% 
      and 36.0%, respectively. Serious AEs were observed in two patients but were 
      considered unrelated to the investigational drug. The incidence of AEs that led 
      to study discontinuation was 1.6%. The incidence of application site AEs and ADRs 
      was 35.2% and 26.4%, respectively. The severity of most events was mild. The 
      incidence of anticholinergic AEs related to dry mouth was 3.2% for thirst and 
      0.8% for dry throat. The long-term efficacy of 20% OL was confirmed by a 
      long-lasting reduction in sweat volume and improvement in the Hyperhidrosis 
      Disease Severity Scale and Dermatology Life Quality Index. This study has several 
      limitations: First the results may include some bias because most of the 
      participants were from the prior DB study; second, the results may not be 
      generalizable because only a few participants were in the age group most 
      susceptible to PPHH (i.e., < 15 years old); and third, the study did not obtain 
      safety information from treatment for more than 52 weeks, so this information 
      must be collected in clinical practice in the future. No reduced therapeutic 
      effect was observed in patients with PPHH in this study after 52-week application 
      of 20% OL. Also, few patients experienced serious AEs or AEs that led to study 
      treatment discontinuation.
CI  - (c) 2023 Japanese Dermatological Association.
FAU - Fujimoto, Tomoko
AU  - Fujimoto T
AUID- ORCID: 0000-0003-0771-3778
AD  - Ikebukuro Nishiguchi Fukurou Dermatology Clinic, Tokyo, Japan.
FAU - Terahara, Takaaki
AU  - Terahara T
AD  - Hisamitsu Pharmaceutical Co., Inc, Tokyo, Japan.
FAU - Okawa, Koji
AU  - Okawa K
AD  - Hisamitsu Pharmaceutical Co., Inc, Tokyo, Japan.
FAU - Inakura, Hiroshi
AU  - Inakura H
AD  - Hisamitsu Pharmaceutical Co., Inc, Tokyo, Japan.
FAU - Hirayama, Yuta
AU  - Hirayama Y
AUID- ORCID: 0009-0008-7117-5066
AD  - Hisamitsu Pharmaceutical Co., Inc, Tokyo, Japan.
FAU - Yokozeki, Hiroo
AU  - Yokozeki H
AUID- ORCID: 0000-0002-5773-9485
AD  - Department of Dermatology, Graduate School of Medical and Dental Sciences, Tokyo 
      Medical and Dental University, Tokyo, Japan.
LA  - eng
GR  - Hisamitsu Pharmaceutical Co., Inc./
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230821
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - K9P6MC7092 (oxybutynin)
RN  - 0 (Mandelic Acids)
SB  - IM
MH  - Humans
MH  - Adolescent
MH  - Treatment Outcome
MH  - *Mandelic Acids/adverse effects
MH  - *Hyperhidrosis/drug therapy
MH  - Double-Blind Method
OTO - NOTNLM
OT  - anticholinergic
OT  - long-term study
OT  - oxybutynin hydrochloride
OT  - primary palmar hyperhidrosis
OT  - topical
EDAT- 2023/08/22 06:42
MHDA- 2023/11/06 06:42
CRDT- 2023/08/22 01:12
PHST- 2023/07/19 00:00 [revised]
PHST- 2023/05/09 00:00 [received]
PHST- 2023/07/28 00:00 [accepted]
PHST- 2023/11/06 06:42 [medline]
PHST- 2023/08/22 06:42 [pubmed]
PHST- 2023/08/22 01:12 [entrez]
AID - 10.1111/1346-8138.16922 [doi]
PST - ppublish
SO  - J Dermatol. 2023 Nov;50(11):1459-1472. doi: 10.1111/1346-8138.16922. Epub 2023 
      Aug 21.