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Also known as glycopyrronium Topical Wipes
glycopyrronium Wipes · 3 trials · 1 indication
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
| Arm | Type | Description |
|---|---|---|
| glycopyrronium | EXPERIMENTAL | glycopyrronium Topical Wipes |
| Vehicle | PLACEBO_COMPARATOR | glycopyrronium Topical Wipes, Vehicle |
| Name | Type | Description |
|---|---|---|
| glycopyrronium Topical Wipes | DRUG | Topical wipes containing glycopyrronium |
| Vehicle | OTHER | Vehicle (placebo) topical wipes |
Inclusion Criteria: * Male or female ≥ 9 years of age. * Primary, axillary hyperhidrosis of at least 6 months duration. * Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline. * Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline. * Sweat production of at least 50 mg over 5 minutes in...
Glycopyrronium Wipes are being developed for the treatment of hyperhidrosis, a condition of excessive sweating. The clinical program has focused specifically on primary axillary hyperhidrosis, meaning excessive sweating of the underarms. The product is a topical small molecule formulation applied as a wipe.
Glycopyrronium Wipes work as an antagonist at muscarinic acetylcholine receptors, specifically CHRM1, CHRM3, CHRM4, CHRM2, and CHRM5. By blocking these receptors, the drug reduces cholinergic signaling that drives sweat gland activity. This anticholinergic mechanism is the basis for its use in hyperhidrosis.
Glycopyrronium Wipes are being developed by Journey Medical Corporation, which trades under the ticker DERM. The company is the sponsor of the clinical development program for this topical hyperhidrosis treatment.
Glycopyrronium Wipes are in Phase 3 clinical development. Three Phase 3 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Three completed Phase 3 trials have evaluated glycopyrronium Wipes in hyperhidrosis: NCT02553798, a long-term safety study with 564 subjects; NCT02530294, with 353 subjects; and NCT02530281, with 344 subjects. All were randomized, double-blind, and placebo-controlled, enrolling a total of 1,261 participants.
Yes, glycopyrronium Wipes are also known as glycopyrronium Topical Wipes or Glycopyrronium Topical Wipes. These names refer to the same investigational product being developed by Journey Medical Corporation for hyperhidrosis.