Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational small molecule being developed for hyperhidrosis, a condition of excessive sweating. It is a topical wipe formulation intended to treat axillary hyperhidrosis, or excessive underarm sweating. The drug is in Phase 3 clinical development and has not been approved by the FDA.
Glycopyrronium Wipes is an anticholinergic agent that works by blocking the action of acetylcholine on sweat glands, reducing sweat production. It is applied topically to the underarm area to treat primary axillary hyperhidrosis. The drug is in Phase 3 clinical development for this indication.
Glycopyrronium Wipes is being developed by Journey Medical Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol DERM. The company is conducting Phase 3 clinical trials for the drug in patients with hyperhidrosis.
Glycopyrronium Wipes is in Phase 3 clinical development for hyperhidrosis. It is an investigational drug and has not been approved by the FDA. Three Phase 3 trials have been completed, including two efficacy studies and one long-term safety study, with a total enrollment of 1,261 patients.
Glycopyrronium Wipes has completed three Phase 3 clinical trials. NCT02530281 and NCT02530294 studied the drug in patients with axillary hyperhidrosis, while NCT02553798 assessed long-term safety in primary axillary hyperhidrosis. All trials were randomized, double-blind, and placebo-controlled, enrolling patients aged 9 years and older.
Glycopyrronium Wipes is a topical wipe formulation of glycopyrronium, an anticholinergic agent. It is being developed specifically for hyperhidrosis and is administered as a wipe to the underarm area. The drug is in Phase 3 clinical development and has not been approved by the FDA.