Qbrexza nieuw medicijn tegen overmatig oksel zweten

Waaronder oxybutynine en glycopyrronium.

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Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Qbrexza

Qbrexza™ (glycopyrronium) cloth

Qbrexza is a medicated cloth indicated for the topical treatment of primary axillary hyperhidrosis (excessive underarm sweating).

INDICATION

Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications: Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).

WARNINGS AND PRECAUTIONS

Worsening of Urinary Retention: Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.

Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Qbrexza. Advise patients using Qbrexza to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.

Operating Machinery or an Automobile: Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.

ADVERSE REACTIONS

The most common adverse reactions seen in ≥2% of subjects treated with Qbrexza were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.

DRUG INTERACTIONS

Anticholinergics: Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of Qbrexza with other anticholinergic-containing drugs.

INSTRUCTIONS FOR ADMINISTERING QBREXZA

Instruct patients to use one cloth to apply Qbrexza to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that Qbrexza can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qbrexza and any potential adverse effects on the breastfed infant from Qbrexza or from the underlying maternal condition.

Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.

Bron: https://dermira.com/our-medicines/

Meer info (Engels): http://pi.dermira.com/QbrexzaPPI.pdf

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Goede ontwikkeling. Het is dus eigenlijk het medicijn glycopyrronium die we al konden maar dan zo gemaakt dat je het met een doekje onder je oksels kan smeren. Er zijn wel bijwerkingen zoals te lezen. Het zal wel even duren voordat dit hier in Nederland verkrijgbaar is en dan zal het uiteraard (nog) niet vergoed worden. Ik vind het in ieder geval erg hoopvol allemaal.

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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Nog wat meer info: (in het engels)

What is QBREXZA?
QBREXZA is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.

It is not known if QBREXZA is safe and effective in children under 9 years of age.

IMPORTANT SAFETY INFORMATION

Who should not use QBREXZA?
Do not use QBREXZA if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, and Sjögren’s syndrome.

Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.

What should I tell my healthcare provider before using QBREXZA? Before using QBREXZA, tell your healthcare provider about all of your medical conditions, including if you:

• have prostate or bladder problems, or problems passing urine
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if QBREXZA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if QBREXZA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with QBREXZA.


Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. QBREXZA may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use QBREXZA?

• Use QBREXZA exactly as your healthcare provider tells you to use it.
• QBREXZA comes as a single-use pre-moistened cloth in individual pouches.
• QBREXZA should be applied to the clean, dry, intact skin, of your underarm areas only. Do not apply QBREXZA to broken skin. Do not cover the treated area with a plastic (occlusive) dressing.
• Apply QBREXZA to both underarm areas using 1 cloth 1 time every 24 hours.


Applying QBREXZA:

• Carefully tear open the pouch to avoid tearing the QBREXZA cloth.
• Unfold the QBREXZA cloth and apply QBREXZA by wiping across 1 entire underarm 1 time. Using the same QBREXZA cloth, wipe across the other underarm 1 time.
• Throw away (discard) the used QBREXZA cloth in the trash.
• Wash your hands right away after you apply QBREXZA and have thrown away the cloth. It is important that you wash your hands because the QBREXZA that is still on your hands can cause you to have blurred vision if you touch your eyes.
• Do not reuse the QBREXZA cloth.


What should I avoid while using QBREXZA?

• QBREXZA may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using QBREXZA and do not drive, operate machinery, or do hazardous work until your vision is clear.
• QBREXZA is flammable. Avoid heat and flame while applying QBREXZA to your skin.


What are the possible side effects of QBREXZA?
QBREXZA can cause serious side effects, including:

• New or worsened urinary retention. People who use QBREXZA may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
– difficulty urinating
– urinating frequently
– urination in a weak stream or drips
– full bladder or difficulty emptying your bladder (distended bladder)
If you have these symptoms, stop using QBREXZA and call your healthcare provider right away.

• Problems with control of your body temperature. QBREXZA can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body (generalized) and stop using QBREXZA if you develop lack of sweating on your body.

Stop using QBREXZA and call your healthcare provider right away if you develop any of these symptoms of heat illness:
– hot, red skin
– decreased alertness or passing out (unconsciousness)
– fast, weak pulse
– fast, shallow breathing
– increased body temperature (fever)


• Blurred vision. If you develop blurred vision during treatment with QBREXZA, call your healthcare provider, stop using QBREXZA and do not drive, or operate machinery, or do hazardous work until your vision is clear.


The most common side effects of QBREXZA include:

• dry mouth
• dilation of the pupils of your eyes (mydriasis)
• sore throat
• skin redness, burning/stinging or itching in underarm area
• headache
• problems with urination
• blurred vision
• nasal dryness
• throat, eye, and skin dryness
• constipation


These are not all of the possible side effects of QBREXZA.
Thijs
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Vond vandaag onderstaande. Goed nieuws denk ik want zo te lezen komt het ook naar Europa/Nederland.

Glycopyrronium tosylate

Qbrexza
Stofnaam
Glycopyrronium tosylate
Domein
Chronische immuunziekten
Reden van opname in Horizonscan
Nieuw middel (specialité)
Hoofdindicatie
Huidziekten
Uitgebreide indicatie

primary axillary hyperhidrosis in patients aged 9 years and older

1. Product
Merknaam
Qbrexza
Fabrikant
Dermira
Toedieningsweg
Lokaal
Bekostigingskader
Extramuraal (GVS)
Aanvullende opmerkingen

Toedieningsvorm: geïmpregneerde doek. Werkingsmechanisme: "A tosylate salt of glycopyrrolate, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation." In VS geregistreerd: QBREXZA (glycopyrronium) cloth, 2.4%, for topical use.

2. Registratie
Registratieroute
Centraal (EMA)
Datum indiening
2019
Verwachte registratie
2020
Weesgeneesmiddel
Nee
Fase registratie
Klinische studies
Aanvullende opmerkingen

ATMOS-1, -2; improved disease symptoms, well tolerated in extension study. Geregistreerd door de FDA.

3. Therapeutische waarde en behandelschema
Therapeutische waarde
Geen oordeel

Deze inschatting doet geen uitspraak over de mogelijke opname in het pakket.
Onderbouwing
Therapeutische waarde moeilijk in te schatten. Gebruiksgemak is groot, hyperhidrosis komt veel voor en is soms erg lastig, en minder frequent echt invaliderend. Er zijn geen oplossingen die voor 100% werken op dit moment voor dit probleem. Het lijkt wel een goede en bruikbare aanwinst voor het therapeutisch arsenaal, er is geen vergelijkbaar middel. Of een verbetering van 60% zweten voldoende is is lastig in te schatten.
Behandelduur
Niet gevonden
Toedieningsfrequentie
1 maal per dag
Dosering per toediening
De geïmpregneerde doek (2,4%) moet men 1x/dag over de oksels vegen.
Bronnen

NCT02553798, NCT02530281, NCT02530294
Aanvullende opmerkingen

In fase 3 trials vergeleken met vehiculum gedurende 4 weken 1dd aanbrengen op de huid. N= 229 patienten versus 115 met vehiculum alleen. Verbeterde score van ASDD-item2 van 59% (verum) vs 25% (vehiculum).

4. Verwacht patiëntvolume per jaar
Aanvullende opmerkingen

Geschatte prevalentie in NL van 1-3%, geschatte prevalentie van ernstige hyperhidrosis axillaris is 1%. Dus max 170.000 patiënten.

5. Verwachte kosten per patiënt per jaar
Kosten
€ 300 - € 500
Bronnen

GIP databank
Aanvullende opmerkingen

De vergoeding per gebruiker voor Botuline toxine (voor verschillende indicaties) in 2016 betrof 399,10 euro. De verwachting is dat de vergoeding voor dit middel een bedrag is in dezelfde range.

6. Mogelijke totale kosten per jaar

Er is op dit moment niets bekend over de mogelijke totale kosten.

7. Off-label gebruik

Er is op dit moment niets bekend over off-label gebruik.

8. Indicatieuitbreiding(en)
Indicatieuitbreiding(en)
Nee

9. Overige informatie

Er is op dit moment geen overige informatie.

Bron: https://www.horizonscangeneesmiddelen.n ... en/versie1
Erje
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Maar dezelfde bijwerkingen dus?
Dat is wel jammer.
Thijs
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Nou het is een doekje wat je smeert onder je oksels. Kan me niet voorstellen dat het dezelfde bijwerkingen geeft als de pil die je moet innemen.
JWBokx
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Thijs schreef: do 11 jul 2019, 09:19 Nou het is een doekje wat je smeert onder je oksels. Kan me niet voorstellen dat het dezelfde bijwerkingen geeft als de pil die je moet innemen.
Als ik het goed lees smeer je het niet onder je oksel:
apply QBREXZA by wiping across 1 entire underarm 1 time. Using the same QBREXZA cloth, wipe across the other underarm 1 time.
Dus kennelijk is het een ander manier van medicijn in de bloedbaan te krijgen waardoor de bijwerkingen dus hetzelfde zijn.
Het kan alleen geen schade aan de maag toebrengen, maar dat doen de pilletjes ook niet zover ik weet.
Thijs
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Het schijnt in België al verkrijgbaar te zijn. Kost 160 euro als het goed is. Zijn er Belgische bezoekers hier die het al geprobeerd hebben? Ik lees op internationale fora veel goede berichten. Ook mensen die het op de handen gebruiken maar dat schijnt niet goed te werken. Vergoed zal het uiteraard niet worden in Nederland... pfff
TomD
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

Bericht door TomD »

Hi Thijs,

Waar zou dit -in België- dan verkrijgbaar zijn?

Bedankt,
Tom
Thijs
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Eerlijk gezegd weet ik dat niet. Probeer eens een paar apotheken te bellen.....
Thijs
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Dus kennelijk is het een ander manier van medicijn in de bloedbaan te krijgen waardoor de bijwerkingen dus hetzelfde zijn.
Het kan alleen geen schade aan de maag toebrengen, maar dat doen de pilletjes ook niet zover ik weet.
Ik heb het aan dermatoloog Wim Venema gevraagd, onze medisch adviseur. Zijn strekking luidt:

In principe wordt Qbrexza lokaal toegepast. Het blokkeert de signaaloverdracht van de zenuwuiteinde naar de zweetklieren. Eigenlijk net als botox dit doet, maar dan net iets anders. Qbrexza bestaat uit glycopyrronium. (een broertje van de orale glyco)
Er kan wat glycopyrronium van de qbrexza doekjes in je bloedbaan komen waardoor je dus ook op andere plaatsen minder kunt gaan zweten en je dus ook wat bijwerkingen kunt krijgen. Dit is echter minimaal en is niet het doel an sich. Het doel is plaatselijk te behandelen.
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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Thijs schreef: wo 04 sep 2019, 13:07
Dus kennelijk is het een ander manier van medicijn in de bloedbaan te krijgen waardoor de bijwerkingen dus hetzelfde zijn.
Het kan alleen geen schade aan de maag toebrengen, maar dat doen de pilletjes ook niet zover ik weet.
Ik heb het aan dermatoloog Wim Venema gevraagd, onze medisch adviseur. Zijn strekking luidt:

In principe wordt Qbrexza lokaal toegepast. Het blokkeert de signaaloverdracht van de zenuwuiteinde naar de zweetklieren. Eigenlijk net als botox dit doet, maar dan net iets anders. Qbrexza bestaat uit glycopyrronium. (een broertje van de orale glyco)
Er kan wat glycopyrronium van de qbrexza doekjes in je bloedbaan komen waardoor je dus ook op andere plaatsen minder kunt gaan zweten en je dus ook wat bijwerkingen kunt krijgen. Dit is echter minimaal en is niet het doel an sich. Het doel is plaatselijk te behandelen.
Thx!
Thijs
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Re: Qbrexza nieuw medicijn tegen overmatig oksel zweten

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New Research Guides Qbrexza® Palmar Hh Treatment

Since the FDA-approval of the anticholinergic-containing topical cloth called Qbrexza® for the treatment of axillary (underarm) hyperhidrosis, many of us have wondered about off-label use for excessive sweating of the hands. Some clinicians have tried it, but there hasn’t been any published or official guidance as to the most effective and safe regimen – until now!

IHhS co-founder and board member Dr. David Pariser, and his research colleagues (Erin Rivera, MS and Danielle Benedict), recently conducted a study to compare four different ways of using Qbrexza to manage palm sweating. Their results were published in the May 2022 edition of Journal of Drugs in Dermatology. Kudos to Pariser, Rivera and Benedict for following their independent scientific curiosity and making this study happen! Thanks also to their patients for helping to further our understanding of Hh treatments and best practices by taking part in the project! (More chances to participate in research are coming soon, so watch your email inbox and make sure you are subscribed to receive our messages.)

“People suffering with excessive sweating of the hands don’t have a lot of treatment options," says Pariser, "so it was logical to try a treatment proven to be effective on the underarms to see if it would work on the hands. We conducted this study in a scientific way to determine the best way to use the anticholinergic cloths on the hands. The results described in this article were published in a dermatology journal so that everyone could benefit from the knowledge.”

In the study, the researchers assigned palmar hyperhidrosis patients to four different groups – each applying the Qbrexza topical cloth to their palms once a day for four weeks in a slightly different manner:

Leaving the medication on the hands for 15 minutes before washing them
Leaving the medication on the hands for 30 minutes before washing them
Leaving the medication on the hands overnight before washing them
Leaving the medication on the hands for 30 minutes with occlusion (occlusion is a non-breathable barrier on top of the skin) and then washing them.
The researchers’ goal was to find the Qbrexza administration routine for the hands that delivered the optimal balance of high efficacy (benefit), and low side effects.

One hundred and twenty patients, age nine years or older with self-reported excessive palm sweating took part in the study, which lasted four weeks and consisted of one of the above daily application routines. There were twelve participants aged 9-15 years and nine participants aged 16-17 years. The oldest participant was 56 years old. Seventy-three females and forty-seven males took part. Ten participants were multi-racial, 19 Black, and 80 white. The average length of time the participants reported having had hyperhidrosis was about 20 years.

All participants were instructed to wipe both their hands continuously with one Qbrexza cloth until the cloth was dry (about 3 minutes) to ensure that all the medication in the cloth was being applied. This significantly differs from Qbrexza application instructions for underarms, which are to wipe each underarm just once with the cloth. The researchers asked the palmar patients to apply the cloth for longer because the skin on the palms is thicker than in the underarms, and they theorized it would take more medication to have an effect on the palms.

After using the cloth for three minutes to apply the medication to their hands, patients in three of the groups were instructed to put on clean cotton gloves and wear the gloves for either: 15 minutes, 30 minutes, or overnight. Those in the fourth group were told to put on occlusive (non-breathable) gloves and wear those for 30 minutes instead of cotton gloves. After the appropriate time period, patients in each group were told to take off the gloves and wash their hands thoroughly with warm water and soap, and to dry them. This was a very important step to help prevent the transfer of any of the anticholinergic medicine to the eyes where it can cause mydriasis (pupil dilation). Despite this, mydriasis was still the most common side effect seen in the study, presumably from the inadvertent introduction of the medication into one or both eyes.

Three out of the 120 study participants did not complete the study due to side effects which were: for one patient, blurred vision, urinary hesitancy (difficulty urinating) and pupil dilation; for the second patient, burning and itching of the treatment area; and for the third patient, pupil dilation that didn’t resolve after three days. A few other participants had side effects, likely from systemic absorption of the medication into the body, and these were seen at about the same rates as when people use Qbrexza for the underarms; they were not severe enough to make these participants leave the study. Any skin reactions reported by participants were described as mild and resolved on their own.

As the study went on, it became clear that those patients using occlusion (the non-breathable gloves) were getting the least results from Qbrexza, perhaps (the researchers theorized) because occlusion causes more sweating, which then can dilute – or “wash out” - the medication.

The study found that the application of the Qbrexza cloth onto both hands (until the cloth was dry or about 3 minutes), wearing clean cotton gloves for 30 minutes, and then washing the hands achieved the best sweat-reducing results with the most acceptable safety profile. For this group, “hand sweat severity” dropped an average of 4 points out of a 10-point scale.

Another interesting discovery from the study: it seems that palmar hyperhidrosis patients may need to allow more time than axillary hyperhidrosis patients for Qbrexza to start to work for them. While previous research has shown that underarm excessive sweating is noticeably reduced after one week of daily Qbrexza use, this study found that palms respond more slowly and the researchers recommend that any future studies of Qbrexza for the palms be longer than 4 weeks. The researchers also recommend more studies of Qbrexza to determine exactly how effective this treatment can be for excessive palmar sweating. It should also be noted that in the U.S., health insurance companies may not provide coverage for off-label treatments, such as this one. Ideally, the makers of Qbrexza (we hope you are reading this!) would pursue additional labeling from the FDA to make palmar Hh an official indication for this treatment. If there is any movement in that direction, we will let you know!

Qbrexza is currently marketed by Journey Medical Corporation of Scottsdale, Arizona. The research discussed here was initiated, however, when Qbrexza was owned by Dermira Inc., a wholly owned subsidiary of Eli Lilly and Company. The Board of Directors of the International Hyperhidrosis Society, in their treatment algorithms, currently recommends Qbrexza as a first-line treatment for primary axillary hyperhidrosis (underarm excessive sweating). Depending upon how treatment of the palms with Qbrexza seems to be working, based on our board’s clinical experiences, we might consider updating the palmar treatment algorithms. Again, we will let you know if that is the case.

PRO TIP: Healthcare providers interested in meeting and talking to this study’s lead investigator, Dr. David Pariser, should plan on attending the International Hyperhidrosis Society’s Master Class, November 4-5, 2022 in Charleston, SC. EmailChristine@SweatHelp.org today and include “2022 Hh Master Class” in the subject line of your email and you’ll be added to our VIP Early Alert mailing list for registration details. We can’t wait to hear from you!

Hyperhidrosis sufferers should know that Dr. Pariser and his colleagues are incredibly committed to helping hyperhidrosis patients, you can find his Virginia practice details here. Or, use our Clinician Finder to locate other IHhS-Educated practitioners. Want to support our research and education? Please donate today!

Ready to dig even deeper on this topic? Read the full study here:
Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis

Journal of Drugs in Dermatology, May 2022

David M. Pariser MD, Erin Rivera MS, Danielle Benedict

Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, VA.

Bron: https://www.sweathelp.org/home/news-blo ... rexza.html

De Qbrexza-doekjes kunnen dus ook tegen overmatig transpireren aan de handen worden gebruikt. Hoog tijd dat die dingen naar Nederland komen.

Zie hieronder ook het studieverslag hiervan.
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