EUCTR2022-000922-46-DE进行中（未招募）1 期
An Open-Label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% GPB Cream in Adolescents With Severe Primary Axillary HyperhidrosisPIP decision number updates: P/0565/2021; P/0467/2022
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Medical diagnosis of severe primary axillary hyperhidrosis with symptoms for at least 3 months before Screening and with a PRHS score of =5 at Screening 2 and Day 1
- •2. At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement) at Screening 2
- •3. Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile =10 and =90
- •4. Local tolerability assessment (skin reaction) score = 0
- •5. Patient and legal guardians are willing and able to comply with protocol requirements, including blood sample collection
- •6. Patient and legal guardians are capable of understanding the nature, significance, and implications of the clinical study and to form a rational intention in the light of the facts, voluntarily agree to participation and the study’s provisions, and legal guardians have duly signed the informed consent form
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hyperhidrosis-related exclusion criteria:
- •1. Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases (such as but not limited to hyperthyroidism, lymphoma, and malaria) or secondary to the use of medication (such as but not limited to antidepressants or sympathomimetics)
- •2. Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
- •3. Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
- •Medical history and concomitant disease exclusion criteria:
- •4. Hypersensitivity to glycopyrronium and its salts (such as glycopyrronium bromide), or to any of the excipients of the investigational medicinal product (IMP)
- •5. Corrected QT (QTc) >450 msec, or QTc =480 msec in patients with bundle branch block
- •6. Aspartate aminotransferase and alanine aminotransferase =2 x upper limit of normal (ULN), alkaline phosphatase and bilirubin >1.5 x ULN at Screening (free bilirubin >1.5 × ULN is acceptable if bilirubin fraction test result of direct bilirubin <35% is available)
- •7. Hashimoto’s disease
- •8. Active or past neuromuscular disease
- •9. Glaucoma
- •10. Active or past acute bleeding with unstable heart and blood circulation status
- •11. Active chronic inflammatory disease of the large bowel (severe ulcerative colitis)
- •12. Active or past chronic inflammation of the large bowel complicated by severe extension of the colon (toxic megacolon complicating ulcerative colitis)
- •13. Active or past blockage of the bowel as a result of paralysis of the bowel muscles (paralytic ileus)
- •14. Myasthenia gravis
- •15. Sjögren syndrome
- •16. Dermal disorders (ie, infections, irritations, or inflammation) in one or both axilla(e)
- •17. Significant cardiovascular disease
- •18. Thyrotoxicosis
- •19. Active or past difficulty in passing urine (successfully treated phimosis is acceptable for study participation)
- •20. Significant cardiac arrhythmia, such as tachycardiac atrial fibrillation and very frequent extrasystoles
- •21. Uncontrolled type 1 or type 2 diabetes mellitus
- •22. Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis
- •23. Gilbert’s syndrome
- •24. Under medical treatment for asthma or severe asthma exacerbation (ie, hospitalization and/or at least 3-day treatment with systemic steroids) within 1 year of Screening
- •25. Acute or chronic bronchitis
- •26. Active epilepsy in treatment or past epileptic attack (within 1 year of Screening)
- •27. Active or past anxiety
- •28. Active depression (with a Patient Health Questionnaire-9 score >10) or past depression
- •29. Active hepatitis B or C virus, or HIV-1 or -2 infection (serology test)
- •30. Active or past alcohol or drug abuse (including abuse of steroids such as, eg, testosterone, methyltestosterone, danazol, or oxandrolone)
- •31. Any score >1 in the neurological assessment of anticholinergic effects at Screening or Day 1
- •32. Current treatment with potassium chloride
- •33. Known disturbed blood-brain barrier (such as patients with recent [within 1 year of Screening] craniocerebral trauma, chemotherapy, radiation therapy, surgery to the skull and brain, or recent intravenous drug users)
- •34. Psoriasis inversa or psoriasis pustulosa generalisata
- •35. Any condition or situation that, in the investigator’s opinion, may interfere with the patient’s participation
研究者
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