Category: Topical

Related Articles

Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.

J Med Econ. 2020 Dec 01;:1

Authors: Bloudek LM, Gillard KK, Nguyen VB, Klein SZ

Abstract
AIMS: Primary axillary hyperhidrosis (PAHH) is a condition characterized by excessive sweating that negatively impacts health-related quality of life, with significant psychological and social impacts. Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the United States for treatment of PAHH in patients 9 years of age and older. Our objective was to assess the cost-effectiveness of GT as first-line topical therapy compared to topical aluminum chloride from a United States commercial perspective.
MATERIALS AND METHODS: A Markov model was developed consisting of four health states based on the Hyperhidrosis Disease Severity Scale (HDSS) over a time horizon of five years with discount rates of 3% for both costs and outcomes. Transitions between health states were driven by HDSS response, defined as an improvement of ≥2 points. Non-responders and those who discontinue could switch to later line treatments or no treatment. Health utility scores were based on HDSS scores, supported by published literature.
RESULTS: Over five years, GT yielded 0.12 greater QALYs and 0.93 greater LYs with response compared to treatment with prescription aluminum chloride at an incremental cost of $10,584. Relative to prescription aluminum chloride, GT resulted in an incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained, $11,349 per LY with response. The ICER fell below $100,000 for 66% of probabilistic sensitivity analysis simulations and below $150,000 for 82% of simulations.
LIMITATIONS: This analysis represents a simplified scenario of a hypothetical PAHH patient. Due to sparse data, assumptions were required for treatment patterns, efficacy, and persistence.
CONCLUSION: Based on the analysis of incremental cost per QALY gained, GT is may be cost-effective relative to prescription aluminum chloride at commonly accepted willingness to pay thresholds.

PMID: 33256494 [PubMed – as supplied by publisher]

Efficacy and Tolerability of 20% Aluminum Sesquichlorohydrate vs 20% Aluminum Chloride for the Treatment of Axillary Hyperhidrosis: A Randomized Controlled Trial.

Dermatol Ther. 2020 Sep 29;:e14354

Authors: Thianboonsong T, Kanokrungsee S, Paichitrojjana A, Udompataikul M, Kamanamool N, Rojhirunsakool S

Abstract
This study evaluated the efficacy and tolerability of topical aluminum sesquichlorohydrate (AS) when compared to aluminum chloride (AC) as a treatment for primary axillary hyperhidrosis. Twenty subjects were included in this randomized, controlled, split-side 8-week study. All participants applied 20% AS and 20% AC lotions in their axillae (one treatment per axilla) every night for 2 weeks; next, the application was reduced to three times a week for 4 weeks. The assessment was performed using the sweating intensity visual scale (SIVS), hyperhidrosis disease severity score (HDSS), patient satisfaction score, and the appearance of adverse effects on weeks 0, 1, 2, 4, 6, and 8. Both AS as well as AC application showed positive results, significantly differing from the baseline, as assessed using SIVS, HDSS, and patient satisfaction score at every follow-up visit; however, no significant difference was observed between the AS and AC groups at any follow-up visit. The mean time of response was 1.14 weeks for both treatments. A side effect was observed in one subject (5%), who reported itching on the AC axilla. The therapeutic effects persisted even after reducing the frequency of application and lasted for at least two weeks after cessation of use. In conclusion, topical 20% AS demonstrated similar efficacy to topical 20% AC in the treatment of primary axillary hyperhidrosis, with a high safety profile. This article is protected by copyright. All rights reserved.

PMID: 32990370 [PubMed – as supplied by publisher]

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis.

Allergy Rhinol (Providence). 2020 Jan-Dec;11:2152656720927703

Authors: Rowane M, Valencia R, Schend J, Jhaveri D, Hostoffer R

Abstract
Introduction: Atopic dermatitis (AD, eczema) is familial chronic inflammatory skin disease of complex etiology and increasing prevalence. Dupilumab is an IL-4 receptor subunit alpha (IL-4Rα) antagonist that is the first Food and Drug Administration-approved biological therapy for moderate-to-severe adult AD inadequately controlled with topical therapies. Adverse effects reported in the literature include injection site reactions, conjunctivitis, headache, and nasopharyngitis.
Objective: We report the first cases of hyperhidrosis and bromhidrosis as side effects from dupilumab (Dupixent®) for the treatment of AD.
Case Reports: Case 1 is a 20-year-old woman with controlled allergic rhinitis and severe AD reported axillary hyperhidrosis with bromhidrosis, comparable to sweat from high-intensity exercise, with no relief from several different over-the-counter antiperspirants. Case 2 is a 61-year-old woman with history of chronic asthma, allergic contact dermatitis, allergic rhinitis, and AD noticed markedly increased sweating with bromhidrosis that was reminiscent of her menopausal symptomology, about 3 months after initiating dupilimab.
Discussion: Traditional immunosuppressive agents and corticosteroids have limited efficacy, numerous side effects, and increased risk of infection. The safety profile and efficacy of the newly approved IL-4Rα antagonist dupilumab may be favorable to oral immunosuppressants, but its use remains limited to severe recalcitrant cases, due to financial implications and lack of long-term safety data and comparative head-to-head trials.
Conclusion: We report improved outcomes with dupilumab, in addition to unpublished cases of bromhidrosis and hyperhidrosis in 2 patients with AD. This report of additional complications may inspire further clinical research and assist clinicians in considering the option of dupilumab for uncontrolled AD, despite aggressive traditional treatment.

PMID: 32489715 [PubMed]

Related Articles

Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.

Pediatr Dermatol. 2020 Mar 08;:

Authors: Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM

Abstract
BACKGROUND/OBJECTIVES: Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294).
METHODS: In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children’s Dermatology Life Quality Index.
RESULTS: Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials.
CONCLUSIONS: Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.

PMID: 32147881 [PubMed – as supplied by publisher]

Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.

J Am Acad Dermatol. 2020 Feb 14;:

Authors: Kirsch B, Smith S, Cohen J, DuBois J, Green L, Baumann L, Bhatia N, Pariser D, Liu PY, Chadha D, Walker P

Abstract
BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE: To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS: A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to one of three doses or vehicle, with daily treatment for 42 days. Coprimary endpoints were the percentage of participants exhibiting ≥1-point improvement in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax; logistic regression), and change in HDSM-Ax as a continuous measure (ANCOVA). Pair-wise comparisons were one-sided with alpha=0.10.
RESULTS: At end-of-therapy, 70%, 79%, 76% and 54% of participants in the 5%, 10%, 15% and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P<0.05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P≤0.0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS: Not powered to detect changes in gravimetric sweat production.
CONCLUSION: Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

PMID: 32068049 [PubMed – as supplied by publisher]