Category: Topical

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Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact

Medicine (Baltimore). 2023 Jul 1;102(S1):e32764. doi: 10.1097/MD.0000000000032764.

ABSTRACT

Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness.

PMID:37499084 | DOI:10.1097/MD.0000000000032764

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Urinary retention and mydriasis secondary to topical glycopyrronium for axillary hyperhidrosis

Am J Health Syst Pharm. 2023 Jun 22:zxad141. doi: 10.1093/ajhp/zxad141. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: Glycopyrronium, also known as glycopyrrolate, is an antimuscarinic competitive inhibitor of acetylcholine widely utilized topically for its anticholinergic properties in dermatology. A single topical glycopyrronium tosylate (GT) formulation is available on the market, and prescription of this medication has become increasingly popular among dermatologists. This medication has a relatively notable adverse effect profile and carries risks that patients need to be counseled on before initiation.

SUMMARY: A 22-year-old female presented to our emergency department (ED) with a chief complaint of difficulty urinating for 48 hours and blurred vision for 2 weeks. Over the course of a week, she visited the ED once and urgent care multiple times due to complications associated with combination use of GT and cetirizine. Although these clinical effects were reversible, the patient impact in our case was profound given the time, cost, and invasive nature of these visits.

CONCLUSION: The notable adverse effects of GT should be considered when prescribing this agent.

PMID:37348110 | DOI:10.1093/ajhp/zxad141

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Oxybutynin gel versus nanoemulgel for treating primary palmar hyperhidrosis: A pilot double-blind randomized controlled trial

J Cosmet Dermatol. 2023 Mar 31. doi: 10.1111/jocd.15715. Online ahead of print.

ABSTRACT

INTRODUCTION: Palmar hyperhidrosis or excessive palmar sweating can reduce one’s quality of life as it is associated with significant physical and occupational disabilities. We compared the gel and nanoemulgel of oxybutynin in treating these patients.

MATERIALS AND METHODS: This pilot study was performed as a double-blind controlled randomized clinical trial at Shahid Faghihi Hospital, Shiraz, Iran. In two randomly allocated groups of 15, patients diagnosed with primary palmar hyperhidrosis by an attending dermatologist applied half a fingertip (roughly 0.25 g) of 1% oxybutynin topical gel or 1% oxybutynin nanoemulgel to both palms every 12 h for one month. The Hyperhidrosis Disease Severity Scale (HDSS), Visual Analog Scale (VAS), and Dermatology Life Quality Index (DLQI) were used to assess the patients at the beginning and end of the study. Statistical analysis was performed using SPSS version 25.

RESULTS: The groups were similar in terms of age (p = 0.800), sex (p = 0.096), and baseline HDSS, VAS, and DLQI scores. The mean HDSS scores decreased significantly (p = 0.001) over time in patients receiving the gel (3.00 ± 1.00 vs. 2.33 ± 0.61) or nanoemulgel (2.92 ± 0.82 vs. 2.14 ± 0.53), without a significant difference between the groups. The same was true for the VAS and DLQI scores. Three patients in each group experienced transient, self-limited anticholinergic side effects (p = 0.983).

CONCLUSION: Oxybutynin gel and nanoemulgel offer equal safety and similar efficacy in reducing the disease severity and increasing the quality of life of patients with palmar hyperhidrosis.

PMID:36999480 | DOI:10.1111/jocd.15715

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A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study in Japan

J Am Acad Dermatol. 2023 Mar 27:S0190-9622(23)00511-X. doi: 10.1016/j.jaad.2023.03.025. Online ahead of print.

ABSTRACT

BACKGROUND: No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.

OBJECTIVE: To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).

METHODS: In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.

RESULTS: At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7 to 39.3%]; P < .001). No serious adverse events (AEs) occurred, and no AEs led to treatment discontinuation.

LIMITATIONS: The treatment period was only 4 weeks.

CONCLUSIONS: In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.

PMID:36990320 | DOI:10.1016/j.jaad.2023.03.025

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Comparison of the Efficacy of Tap Water Iontophoresis Versus Aluminum Chloride Hexahydrate in the Treatment of Palmoplantar Hyperhidrosis

Cureus. 2022 Dec 9;14(12):e32367. doi: 10.7759/cureus.32367. eCollection 2022 Dec.

ABSTRACT

OBJECTIVE: To compare the efficacy of tap water iontophoresis (TWI) versus aluminum chloride (AC) hexahydrate in the treatment of palmoplantar hyperhidrosis.

METHODS: The study was a randomized control trial performed at the dermatology department of Pakistan Navy Station (PNS) Shifa Hospital, Karachi from March 2022 to September 2022. A total of 70 palmoplantar hyperhidrosis patients were included in the study after getting approval from the ethical committee. Patients were divided into two groups. Group A patients were treated with TWI three times a week for four weeks. Group B patients were treated with a 20% AC topical solution applied at night to the affected areas for four weeks. The Hyperhidrosis Disease Severity Scale (HDSS) score for both groups was calculated at baseline, one, two, three, and four weeks. The final response was labeled at four weeks by comparing mean HDSS reduction in both groups. SPSS version 28 (IBM Corp., Armonk, NY) was used for data analysis.

RESULTS: Mean HDSS was compared for both groups at the end of the study, which showed a significant reduction in the mean score from 3.40 ± 0.65 to 1.48 ± 0.78 in group A, as compared to a decline in scores in group B from 3.28 ± 0.67 to 2.14 ± 0.94 (p = 0.002). In group A, zero, one, two, and three points HDSS improvement was 2.9%, 25.7%, 48.6%, and 22.9%, respectively. Whereas in group B, it was 34.3%, 22.9%, 34.3%, and 8.6%, respectively (p = 0.001).

CONCLUSION: As compared to AC topical solution, TWI is an effective, safe, and inexpensive management option for palmoplantar hyperhidrosis. It causes more improvement in HDSS scores and has lesser side effects.

PMID:36627989 | PMC:PMC9826940 | DOI:10.7759/cureus.32367

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Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: results from a Phase 3b trial

J Eur Acad Dermatol Venereol. 2023 Jan 6. doi: 10.1111/jdv.18843. Online ahead of print.

ABSTRACT

BACKGROUND: Primary axillary hyperhidrosis (PAHH) strongly affects the patient’s quality of life. To date, topical treatment options are limited. 1% glycopyrronium bromide (GPB) showed promising efficacy and safety in a pivotal 4-week Phase 3a study.

OBJECTIVES: To assess efficacy and safety of topical 1% GPB cream in patients with severe PAHH in a long-term study of 72 weeks vs. baseline.

METHODS: This was a long-term, open-label, Phase 3b trial for 72 weeks including 518 patients with severe PAHH. Patients were treated with 1% GPB cream once daily for 4 weeks, followed by a flexible dosing scheme (min. twice per week, max. once daily). Primary endpoint was the absolute change in sweat production from baseline to week 12. Further study endpoints included assessment of the severity of PAHH and the impact on quality of life.

RESULTS: Total median sweat production decreased by 119.30 mg (-65.6%, both median) until week 12. Absolute change in sweat production from baseline to week 12 in logarithmic values was statistically significant (p < 0.0001). Patients’ quality of life was improved at all study time points compared to baseline, as assessed by Hyperhidrosis Quality of Life Index and Dermatology Life Quality Index (p < 0.0001). Treatment was safe and locally well-tolerated with only few mild to moderate adverse drug reactions (ADRs). Dry mouth and application site erythema were the most common reported ADRs.

CONCLUSIONS: Treatment with 1% GPB cream over 72 weeks significantly reduces sweat production and improves quality of life in patients with severe PAHH. 1% GPB cream is well-tolerated and provides an effective treatment option for long-term use in patients with severe PAHH.

PMID:36606529 | DOI:10.1111/jdv.18843

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Efficacy, Safety and Quality of Life of Oxybutynin versus Aluminum Chloride Hexahydrate in Treating Primary Palmar Hyperhidrosis

Indian J Dermatol. 2022 May-Jun;67(3):222-227. doi: 10.4103/ijd.IJD_799_20.

ABSTRACT

BACKGROUND: Palmar hyperhidrosis is characterized by excessive sweating beyond the physiological needs of the patient’s body and the most frequent form is primary or essential. Different treatments protocols have been proposed to control or decrease sweating.

AIMS AND OBJECTIVES: This study aimed to compare the efficacy and safety of oral oxybutynin versus topical aluminum chloride hexahydrate (ACH) in treating primary palmar hyperhidrosis. Also, to assess quality of life (QOL) as a measure of improvement of hyperhidrosis state.

MATERIALS AND METHODS: Patients were randomized using the block randomization with sealed envelope method into two treatment groups; oral oxybutynin group and topical ACH group. Hyperhidrosis Disease Severity Scale (HDSS) was used as a primary outcome measure to assess the efficacy of the drug in both groups. Clinical grading and the QOL were used as secondary outcome measures. The safety was evaluated by recording side effects in the follow-up visits.

RESULTS: HDSS, clinical grading and QOL score showed a statistically significant improvement in the oral oxybutynin groups. One week after stoppage of treatment, the symptoms recurred again in both groups with return of HDSS and QOL scores to pretreatment levels. The most common side effects were dry mouth (65.8%) and itching (65.0%) for oral oxybutynin group and topical ACH group; respectively.

CONCLUSION: Treatment of primary palmar hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it gives better results and much more improvement in QOL when compared to topical ACH. QOL questionnaire and clinical grading should also be considered as useful tools in the assessment of response to treatment.

PMID:36386101 | PMC:PMC9644765 | DOI:10.4103/ijd.IJD_799_20

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Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics

Dermatol Ther (Heidelb). 2022 Nov 3. doi: 10.1007/s13555-022-00838-3. Online ahead of print.

ABSTRACT

BACKGROUND: Topical anticholinergics have been reported to be effective in managing hyperhidrosis (HH) given the recent approval of glycopyrronium tosylate.

OBJECTIVE: This review aimed to examine the effectiveness of emerging topical anticholinergic treatments for HH and their associated adverse effects in comparison to current treatment options.

METHODS: We conducted a search within the PubMed and Embase databases for current and emerging topical anticholinergic treatments for primary HH.

RESULTS: The topical anticholinergics that have been recently investigated for use in HH include glycopyrrolate, oxybutynin, sofpironium bromide, and umeclidinium. The only agent currently FDA approved is glycopyrrolate.

CONCLUSION: Knowledge of topical anticholinergic treatment options is important for patient care when managing HH. This review shows that while available safety data thus far are limited, emerging topical anticholinergics pose minimal known human risks.

PMID:36329359 | DOI:10.1007/s13555-022-00838-3

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Mydriasis and anisocoria in a pediatric hyperhidrosis patient with interesting findings in the family cat

Pediatr Dermatol. 2022 Oct 19. doi: 10.1111/pde.15157. Online ahead of print.

ABSTRACT

Here, we report a case of unilateral ocular mydriasis in a pediatric patient with longstanding hyperhidrosis, as well as similar findings in her cat. The patient had been undergoing treatment of her hyperhidrosis with topical glycopyrrolate. This case highlights the potential side effect profile of topical antimuscarinics and the importance of counseling patients on proper precautions.

PMID:36263444 | DOI:10.1111/pde.15157

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Microneedling Delivery of Botulinum Toxin Versus Intradermal Injection in the Treatment of Facial Hyperhidrosis

J Clin Aesthet Dermatol. 2022 Sep;15(9):40-44.

ABSTRACT

BACKGROUND: The current treatments of Facial hyperhidrosis (FH) are often limited and are associated with many adverse effects.

OBJECTIVE: The objective was to study the efficacy and safety of botulinum toxin-A delivery by microneedling versus its intradermal injection in the treatment of FH. Forty-two patients with FH were subjected to microneedling (Mn) followed by topical application of BTX-A on one side of the face and intra-dermal injection of BTX-A on the other side. Two sessions were performed at two week intervals. The assessment tools were Hyperhidrosis Disease Severity Scale (HDSS), the Dermatology Life Quality Index (DLQI), and patient satisfaction.

RESULTS: A score of one of HDSS was achieved in 85.7 percent of patients on the intradermally injected side versus 83.3 percent on the microneedling side (P=0.76%). Most of the patients on the injection side responded with the first session while the microneedling side responded with the second one (P<0.001). The DLQI was highly significant on both sides post-treatment (P<0.001). The side effects were mild in the form of pain on the intradermally injected sides, and mild transient erythema on the microneedling side. The microneedling side showed higher patient satisfaction compared to the intradermally injected side.

CONCLUSION: Both techniques were safe and effective in controlling the FH. Microneedling delivery of BTX-A was less painful and had higher patient satisfaction.

PMID:36213604 | PMC:PMC9529074