Category: Topical

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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

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Intradermal Botulinum Toxin A Injection Versus Topical 2% Glycopyrrolate for the Treatment of Primary Facial Hyperhidrosis: A Pilot Study and Review of Literature

Dermatol Surg. 2022 Aug 1;48(8):843-848. doi: 10.1097/DSS.0000000000003490. Epub 2022 Jun 17.

ABSTRACT

BACKGROUND: Facial hyperhidrosis (HH), a common problem with both cosmetic and psychological impact, interferes with quality of life. Wide range of treatment options is available for HH. Finding the most effective and yet a safe, tolerable option is the main target.

OBJECTIVE: To evaluate and compare clinical efficacy, safety, and tolerability of topical 2% glycopyrrolate versus intradermal Botulinum toxin A injection in facial HH treatment.

MATERIALS AND METHODS: Twenty-four patients with primary facial HH were randomly divided into 2 equal groups: Group A included patients treated by intradermal Botulinum toxin A injection and Group B included patients treated by topical glycopyrrolate gel 2%. Starch iodine test was performed before and after treatment to assess response, along with Hyperhidrosis Disease Severity Scale, Dermatology Life Quality Index (DLQI), and patient satisfaction.

RESULTS: Both modalities showed complete response in 75% of cases with a longer duration of action in botulinum toxin group up to 6 months. Side effects were minor and temporary. Both Hyperhidrosis Disease Severity Scale and DLQI showed statistically significant improvement after treatment.

CONCLUSION: Topical glycopyrrolate 2% showed comparable results to Botulinum toxin A in facial HH treatment with faster onset but shorter duration of action.

PMID:35917265 | DOI:10.1097/DSS.0000000000003490

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Treatment of Hyperhidrosis: An Update

Am J Clin Dermatol. 2022 Jul 1. doi: 10.1007/s40257-022-00707-x. Online ahead of print.

ABSTRACT

Hyperhidrosis is a dermatosis presenting as pathologically excessive focal or generalized sweating. The stigmatizing nature of hyperhidrosis may cause patients to feel embarrassment and apprehension about their symptoms and experience a significant decrease in well-being. Severe cases of hyperhidrosis can also increase the risk of developing psychiatric and somatic comorbidities. Conventional non-surgical treatments of hyperhidrosis include aluminum salts, iontophoresis, botulinum toxin injections, and oral glycopyrronium. In recent years, new topical anticholinergic medications and devices have emerged that may improve the patients’ symptoms and even prevent the development of comorbidities. The treatment of hyperhidrosis can be a complex matter and may require the combination of several therapies. The purpose of this paper was to firstly review the literature on existing non-surgical treatment options for hyperhidrosis, and secondly provide a stepwise approach to investigating and treating patients with hyperhidrosis.

PMID:35773437 | DOI:10.1007/s40257-022-00707-x

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THE PHARMACOLOGICAL TREATMENT AND MANAGEMENT OF HYPERHIDROSIS

Expert Opin Pharmacother. 2022 Jun 10. doi: 10.1080/14656566.2022.2083499. Online ahead of print.

ABSTRACT

INTRODUCTION: Idiopathichyperhidrosis is a dysfunctional disorder involving eccrine sweat glands and its impact on patients’ daily quality of life is well-known. Unlike some years ago, when only poor effective and safe therapeutic alternatives were available, nowadays, several emerging pharmacological active substances have gained significant space as treatment options.

AREAS COVERED: The authors report on, in this narrative review, the emerging data from the literature focusing on the pharmacological treatments to draw up a drug treatments flow-chart for patients with idiopathic hyperhidrosis, taking into consideration specific differences among axillary, palmoplantar and craniofacial hyperhidrosis.

Idiopathic hyperhidrosis, regardless of the site of involvement, remains a functional disorder that places a significant burden on patients. After balancing efficacy against adverse events, systemic therapy, although off-label for all forms of hyperhidrosis can represent an additive therapeutic option for patients with insufficient response to topical treatment according to a step wise therapeutic approach. Until the pathophysiological mechanisms underlying hyperhidrosis are clear, and the etiological therapeutic approach become realistic, the greatest challenge in the therapeutic management of hyperhidrotic patients seems to be the search for the most convenient combination between different therapeutic modalities (topical and systemic agents, and botulinum toxins) to achieve long-term control of the disease symptoms.

PMID:35686667 | DOI:10.1080/14656566.2022.2083499

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Hyperhidrosis: disease aetiology, classification and management in the light of modern treatment modalities

Postepy Dermatol Alergol. 2022 Apr;39(2):251-257. doi: 10.5114/ada.2022.115887. Epub 2022 May 9.

ABSTRACT

Hyperhidrosis is a disorder of sweat glands characterized by overproduction of sweat, which is inadequate to the thermoregulatory needs of the body system. Owing to the heavy social and economic burden of the disproportionate perspiration, current treatment methods still do not seem to be sufficient enough to reach patients’ expectations. Therefore, the researchers continue a robust pursuit of novel therapy modalities such as topical treatment methods, oral agents, minimally-invasive medical approach and surgical techniques. In this review article authors summarise the disease outline with the emphasis on the new era of hyperhidrosis treatment methods.

PMID:35645673 | PMC:PMC9131949 | DOI:10.5114/ada.2022.115887

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Transfersomal eosin topical delivery assisted by fractional CO2 laser for photodynamic treatment of palmar hyperhidrosis: case study

Drug Deliv Transl Res. 2022 Apr 20. doi: 10.1007/s13346-022-01164-z. Online ahead of print.

ABSTRACT

Hyperhidrosis is a condition in which the cholinergic receptors on the eccrine glands are overstimulated, resulting in excessive sweating. It is considered a serious cosmetic and psychological problem that affects the patient’s quality of life. Searching for novel treatment modalities is required to minimize the side effects and to attain better patient satisfaction.Photodynamic therapy (PDT), using eosin as a photosensitizer, is developed as a promising modality of the treatment of palmar and axillary hyperhidrosis. In this study, we treated six cases suffering palmar hyperhidrosis by applying the fractional CO2 laser prior to PDT session. For PDT, a hydrogel of eosin loaded in a transfersomes as a nano-delivery carrier was applied for 5 min, followed by irradiation by intense pulsed light (IPL). The prepared transfersomes loaded by eosin were spherical in shape with encapsulation efficiency of 33 ± 3.5%, particle size 305.5 ± 5.7 nm, average zeta potential of – 54 ± 7.6 mV with 80 ± 4% of the loaded eosin was released after 3 h. Two cases achieved 90% improvement after four sessions, three patients needed six sessions to show 75% improvement, while one patient showed only 25% improvement after six sessions. This resulted in shortening the time of PS application and decreasing the number of sessions required to achieve acceptable improvement. More clinical studies on large number of patients are required to optimize the results.

PMID:35441986 | DOI:10.1007/s13346-022-01164-z