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A double-blind, placebo-controlled study of HP-5070 in patients with primary hyperhidrosis

A double-blind, placebo-controlled study of HP-5070 in patients with primary hyperhidrosis

285

Sex: 20% group; Male 56.3% (81/144 patients), Female 43.8% (63/144 patients), Placebo group; Male 62.1% (87/140 patients), Female 37.9% (53/140 patients) Mean age (Minimum, Maximum): 20% group; 34.1 (12, 60) years, Placebo group; 35.7 (12, 77) years

Screened: 363 Enrolled: 285 (20% group; 144, Placebo group; 141) Untreated: 20% group; 0, Placebo group; 1 Treated: 20% group; 144, Placebo group; 140 Discontinued: 20% group; 0, Placebo group; 2 Completed: 20% group; 144, Placebo group; 138 FAS: 20% group; 144, Placebo group; 140 Safety analysis population: 20% group; 144, Placebo group; 140

The incidence of adverse events (AEs) was 22.9% (33/144 patients) in the 20% group, and 14.3% (20/140 patients) in the placebo group. The incidence of adverse drug reactions (ADRs) (treatment-related AEs) was 12.5% (18/144 patients) in the 20% group, and 8.6% (12/140 patients) in the placebo group. The majority of AEs were mild. AEs with an incidence of 2% or more in either treatment group were application site dermatitis (4.2%), thirst (3.5%), nasopharyngitis (3.5%) and application site pruritus (2.1%) in the 20% group, and glucose urine present (2.9%) in the placebo group. No deaths and serious AEs were reported. No AEs leading to discontinuation of the investigational product were reported. The incidents of application site AEs was 9.0% (13/144 patients) in the 20% group, and 3.6% (5/140 patients) in the placebo group.

Primary endpoint: The responder rate for sweat volume (patients with a reduction of sweat volume of at least 50% from baseline) at week 4 was 52.8% (76/144 patients) in the 20% group and 24.3% (34/140 patients) in the placebo group. The between-group difference with its 95% confidence interval was 28.5% (17.0, 39.4). The responder rate for sweat volume at week 4 was significantly higher compared with the placebo group (P < 0.001, Fisher's exact test). Secondary endpoints: The percent change and absolute change from baseline in sweat volume at week 4 also showed improvement compared with the placebo group. As for the responder rate for Hyperhidrosis Disease Severity Scale (HDSS) at week 2 and week 4, not only the rate of patients with improvement of 1 point or more from baseline but also that of patients with improvement of 2 points or more from baseline were higher from week 2 compared with the placebo group. The mean change from baseline in the Dermatology Life Quality Index (DLQI) score at week 4 was -3.7 in the 20% group and -2.2 in the placebo group. Improvement of approximately 4 points was observed in the 20% group.

A four-week randomized, placebo-controlled study of HP-5070 (20% formulation) was conducted in patients with palmar hyperhidrosis, which demonstrated the efficacy of HP-5070 for palmar hyperhidrosis.

Mar. 08, 2024

Mar. 28, 2023

https://www.sciencedirect.com/science/article/abs/pii/S019096222300511X?via%3Dihub

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200142

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

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

- 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) or placebo

The proportion of responders with the defined volume of sweat

HDSS (Hyperhidrosis Disease Severity Scale)
DLQI (Dermatology Life Quality Index) score
Adverse events

+81-42-648-5551

Oct. 16, 2020

none