Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents Wi… (NCT05863104) | Clinical Trial Compass
CompletedPhase 2
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
Germany44 participantsStarted 2023-03-07
Plain-language summary
The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
Who can participate
Age range12 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening
* 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)
* Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to Kromeyer-Hauschild et al 2001)
* Local tolerability assessment (skin reaction) score = 0
Exclusion Criteria:
* Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria
* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
* Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
* Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)
What they're measuring
1
Number of patients with Adverse Drug Reaction during treatment
Timeframe: Baseline to Day 57
2
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
Timeframe: Baseline to Day 57
3
Αbsolute change in GP plasma concentration from Baseline to Day 15
Timeframe: Baseline to Day 15
Trial details
NCT IDNCT05863104
SponsorDr. August Wolff GmbH & Co. KG Arzneimittel