Qbrexza (glycopyrronium cloth) / Eli Lilly, Fortress, Maruho - LARVOL DELTA

Efficacy and Safety of Glycopyrronium Cloths, a Novel Management for Hyperhidrosis at Amputation Sites: A Randomized Controlled Trial (AAD 2025) - "GTCs offer a promising, self-administered treatment for managing amputation site hyperhidrosis and improving prosthetic function. The risk of systemic absorption warrants further investigation."

Clinical • Dermatology

Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel | N=12 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Dermatology

The Unforeseen Consequences of Glycopyrronium Tosylate Cloths (ASHP 2024) - No abstract available

Brella Sweat Control Patch for primary axillary hyperhidrosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

Sofpironium (Sofdra) for primary axillary hyperhidrosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

Qbrexza Cloths for Hyperhidrosis of Amputation Sites (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: University of Utah | Enrolling by invitation ➔ Completed | N=20 ➔ 14 | Trial completion date: Dec 2024 ➔ Dec 2023

Enrollment change • Patient reported outcomes • Trial completion • Trial completion date • Dermatology

Clinical observation and analysis of skin reactions caused by COVID-19 vaccination (WCD 2023) - "Treatment measures are mostly mild regimens, such as oral antihistamines, compounded glycopyrrolate and topical weak to moderately potent corticosteroid creams. It is essential to recognize that these skin reactions, when followed by awareness, can alleviate patients' concerns about adverse reactions to COVID-19 vaccination and thus actively complete the vaccination"

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Herpes Simplex • Herpes Zoster • Immunology • Infectious Disease • Lichen Planus • Measles • Novel Coronavirus Disease • Psoriasis • Respiratory Diseases • Seborrheic Dermatitis • Urticaria • Varicella Zoster • Vitiligo

Qbrexza Cloths for Hyperhidrosis of Amputation Sites (clinicaltrials.gov) - P2 | N=20 | Enrolling by invitation | Sponsor: University of Utah | Recruiting ➔ Enrolling by invitation | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Enrollment status • Patient reported outcomes • Trial completion date • Trial primary completion date • Dermatology

Clinical observation and analysis of skin reactions caused by COVID-19 vaccination. (PubMed, Dermatol Ther) - "Treatment measures are mostly mild regimens, such as oral antihistamines, compounded glycopyrrolate and topical weak to moderately potent corticosteroid creams. The total duration of these skin adverse reactions ranged from 2 weeks to 1 month."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Herpes Simplex • Herpes Zoster • Immunology • Infectious Disease • Lichen Planus • Novel Coronavirus Disease • Psoriasis • Respiratory Diseases • Seborrheic Dermatitis • Urticaria • Varicella Zoster • Vitiligo

Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis. (PubMed, J Drugs Dermatol) - P2 | "Glycopyrronium cloth can be used successfully to treat palmar hyperhidrosis. Occlusion for 30 minutes had the poorest response presumably due to the increased sweating causing dilution of the study drug."

Journal • Dermatology • Ophthalmology

Pharmacologic Mydriasis Secondary to Topical Glycopyrronium Tosylate Cloths: Clinical Characterization From a Multicenter Analysis. (PubMed, J Neuroophthalmol) - "Mydriasis associated with topical GT seems to be a consequence of local exposure rather than systemic toxicity. Because patients may not volunteer topical GT as a medication, eliciting a history of exposure often requires further specific questioning. Soft contact lens wear and poor postapplication hand hygiene seem to be associated with mydriasis in GT use."

Journal • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Ophthalmology

Topical glycopyrronium tosylate in Japanese patients with primary axillary hyperhidrosis: A randomized, double-blind, vehicle-controlled study. (PubMed, J Dermatol) - "Glycopyrronium tosylate cloth, an anticholinergic drug, has been approved for the topical treatment of primary axillary hyperhidrosis in the USA, but its effects in Japanese patients have not been previously investigated...The incidence of treatment-emergent adverse events leading to treatment modification was low in the three groups. The 4-week use of topical glycopyrronium tosylate improved the patient-reported outcome measure Hyperhidrosis Disease Severity Scale and objectively-evaluated sweat production with a favorable benefit/risk profile."

Clinical • Journal • Dermatology • Ophthalmology

Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects With Primary Axillary Hyperhidrosis (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel; Trial completion date: Nov 2020 ➔ Apr 2023; Trial primary completion date: Sep 2020 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • Dermatology

Qbrexza Cloths for Hyperhidrosis of Amputation Sites (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: University of Utah; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Patient reported outcomes • Dermatology

Qbrexza Cloths for Hyperhidrosis of Amputation Sites (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: University of Utah

Clinical • New P2 trial • Patient reported outcomes • Dermatology

An Open Label Study for Palmar Hyperhydrosis (clinicaltrials.gov) - P2; N=120; Completed; Sponsor: Pariser, Robert J., M.D.

Clinical • New P2 trial • Dermatology

A systematic evidence-based review of treatments for primary hyperhidrosis. (PubMed, J Drug Assess) - "Only three studies - two clinical trials of glycopyrronium cloth (2.4%) and one trial of botulinum toxin A injections in axillary hyperhidrosis were rated as "low" RoB; both had SOE ratings of "moderate" for use in axillary hyperhidrosis - the highest rating included in this review. In hyperhidrosis, as in other clinical conditions, treatment decisions should be patient centered. At this time, because of the quality of evidence, only imprecise estimates of effect are possible for hyperhidrosis treatments included in this review, and statements about comparative effectiveness are not possible."

Journal • Review

Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. (PubMed, Clin Pharmacokinet) - P2 | "These studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact)."

Journal • Pediatrics • Xerostomia

Don't Sweat the Blown Pupil: Anisocoria in Patients Using Qbrexza. (PubMed, Ophthalmology) - No abstract available

Clinical • Journal

Glycopyrronium (Qbrexza) Topical Wipes for Hyperhidrosis. (PubMed, Am Fam Physician) - No abstract available

Journal

A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis (clinicaltrials.gov) - P2; N=72; Completed; Sponsor: Dermira, Inc.; Recruiting ➔ Completed

Trial completion

Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use. (PubMed, Clin Drug Investig) - "Glycopyrronium tosylate (Qbrexza) is available as single-use, pre-moistened cloths and has been approved in the USA for the topical treatment of primary axillary hyperhidrosis in adults and children ≥ 9 years of age...Glycopyrronium tosylate is generally well tolerated, with most adverse events being mild to moderate in severity. Glycopyrronium tosylate thus provides a self-administered, non-invasive alternative to topical antiperspirant therapy and clinic-based treatments in adults with primary axillary hyperhidrosis, and is the only alternative to topical antiperspirants specifically approved in children and adolescents ≥ 9 years of age."

Journal • Review

A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. (PubMed, Am J Clin Dermatol) - P3; "Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged."

Clinical • Journal

Use of gloves when applying topical glycopyrronium for treatment of primary axillary hyperhidrosis. (PubMed, J Am Acad Dermatol) - No abstract available.

Journal

Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects With Primary Axillary Hyperhidrosis (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Clinical • New P2 trial