臨床研究等提出・公開システム

A long-term extension study of HP-5070 in patients with primary hyperhidrosis

A long-term extension study of HP-5070 in patients with primary hyperhidrosis

126

Sex: Male 53.6% (67/125 patients), Female 46.4% (58/125 patients) Mean age (Minimum, Maximum): 34.2 (12, 69) years

Screened: 130 Enrolled: 126 Untreated: 1 Treated: 125 Discontinued: 8 Completed: 117 FAS: 125 Safety analysis population: 125 Pharmacokinetic analysis population: 125

The incidence of adverse events (AEs) was 79.2% (99/125 patients). The incidence of adverse drug reactions (ADRs) (treatment-related AEs) was 36.0% (45/125 patients) The majority of AEs were mild. AEs with an incidence of 5% or more were pyrexia (29.6%), application site dermatitis (8.8%), application site eczema (8.8%), dyshidrotic eczema (8.8%), eczema (8.0%), vaccination site pain (7.2%), nasopharyngitis (6.4%), acne (6.4%), blood uric acid increased (5.6%), back pain (5.6%), and dermatitis contact (5.6%). No deaths were reported. One case each of Henoch-Schonlein purpura and cataract was reported as a serious AE. A causal relationship between both serious AEs and the investigational product was ruled out. The incidence of AEs leading to discontinuation of the investigational product was 1.6% (2/125 patients). The incident of application site AEs and ADRs was 35.2% (44/125 patients) and 26.4% (33/125 patients), respectively. The majority of these AEs were mild.

The responder rate for sweat volume (patients with a reduction of sweat volume of at least 50% from baseline) was 60.7% (74/122 patients) at week 12, 72.0% (85/118 patients) at week 24, 66.7% (78/117 patients) at week 36, 72.6% (85/117 patients) at week 52, and 71.3% (87/122 patients) at the final evaluation (week 52 or at treatment discontinuation). The percent change and absolute change from baseline in sweat volume also remained at similar levels between week 12 and week 52. The mean percent change and absolute change from baseline in sweat volume at the final evaluation were -56.83% and -0.5404 mg/cm2/min, respectively. As for the responder rate for Hyperhidrosis Disease Severity Scale (HDSS) between week 4 and week 52, the rate of patients with improvement of 1 point or more from baseline remained between 70.7% and 87.1%. The responder rate at the final evaluation was 83.2%. The rate of patients with improvement of 2 points or more from baseline remained between 36.5% and 63.5%. The responder rate at the final evaluation was 59.7%. The mean change from baseline on the Dermatology Life Quality Index (DLQI) score between week 4 and week 52 remained between -4.4 and -5.5. Improvement of 4 points or more on DLQI was maintained between week 4 and week 52. The mean change at the final evaluation was -5.3. The mean plasma oxybutynin and N-desethyloxybutynin concentrations at all time points to week 52 were 23.9 ng/mL and 5.62 ng/mL, respectively.

After HP-5070 (20% formulation) was applied to both palms of patients with palmar hyperhidrosis for 52 weeks, it was confirmed to be continuously effective. Serious adverse events or adverse events leading to treatment discontinuation were rarely reported.

Mar. 08, 2024

Aug. 21, 2023

https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.16922

No

https://jrct.niph.go.jp/latest-detail/jRCT2031200143

Customer Service Office

Hisamitsu Pharmaceutical Co., Inc.

2-4-1 Marunouchi, Chiyoda-ku, Tokyo

sodanshitsu@hisamitsu.co.jp

Customer Service Office

Hisamitsu Pharmaceutical Co., Inc.

2-4-1 Marunouchi, Chiyoda-ku, Tokyo

+81-120-381332

sodanshitsu@hisamitsu.co.jp

Complete

Oct. 19, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who continued into the extension
- Japanese patients with primary local hyperhidrosis who completed the prior study
- Patients wishing to continue to receive HP-5070 after participating in the prior study

New patients
- Japanese patients aged 12 years or older
- Patients with a diagnosis of primary local hyperhidrosis
- Patients with involvement of palmar sites

Patients who continued into the extension
- Patients with a resting pulse rate of less than 45 beats per minute or more than 90 beats per minute measured during the pre-observation period of the prior study
- Patients with a QTcF of 450 msec or more on a 12-lead ECG measured during the pre-observation period of the prior study
- Patients with abnormal waveforms on a 12-lead ECG measured during the pre-observation period of the prior study

New patients
- Patients with secondary hyperhidrosis
- Patients with heavy sweating due to climacteric disturbance
- Patients who have undergone surgery for hyperhidrosis (sympathectomy, nerve block, laser surgery, etc.)

Both

Primary local hyperhidrosis

Transdermal application of HP-5070 (oxybutynin hydrochloride)

Adverse events

The proportion of responders with the defined volume of sweat

+81-42-648-5551

Oct. 16, 2020

none