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Palmar HyperhidrosisNCT06731101

Stellate Ganglion Block Versus Oral Medication in Treatment of Palmar Hyperhidrosis

A study testing Bupivacaine + Lidocaine +dexamethasone and Tryptizole + Librax in people with Palmar Hyperhidrosis, run by Fayoum University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to compare between ganglion block versus combined oral anticholinergic and antidepressant drugs on treatment of palmar hyperhidrosis Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Palmar Hyperhidrosis
What is being tested?
Bupivacaine + Lidocaine +dexamethasone and Tryptizole + Librax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
15 Jan 2025to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age from 20 to 45 years.
  • Both genders.
  • Exhibiting primary palmar hyperhidrosis. Exclusion criteria: -
  • 1. An inability of patient to cooperate. 2. Known allergies to anticholinergic or antidepressant drugs.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Taha mohamed agmy

    Al Fayyum, 084

Other trials in Egypt

About this study

Official title: The Efficacy of Stellate Ganglion Block Versus Combined Oral Anticholinergic and Antidepressant Drugs on Treatment of Palmar Hyperhidrosis; A Randomized Comparative Study

The aim of the study is to compare between ganglion block versus combined oral anticholinergic and antidepressant drugs on treatment of palmar hyperhidrosis

Read the detailed description

Palmar hyperhidrosis is a medical condition characterized by excessive sweating specifically from the palms of the hands. This condition can significantly impact an individual's quality of life, leading to social embarrassment, anxiety, and difficulties in daily activities. It is classified as a type of primary hyperhidrosis, which means it occurs without an identifiable underlying medical cause (Solish et al., 2022).

The prevalence of palmar hyperhidrosis is estimated to affect about 1% to 3% of the population. Symptoms typically begin in childhood or adolescence, often becoming more pronounced during periods of hormonal changes such as puberty. The condition may run in families, suggesting a genetic predisposition (Wadhawa et al., 2019).

The underlying mechanism involves hyperactivity of the sympathetic nervous system, particularly affecting the eccrine sweat glands located in the palms (Kisielnicka et al., 2022).

Unlike normal sweating, which primarily serves thermoregulation (cooling the body), palmar hyperhidrosis is triggered by emotional stimuli such as stress or anxiety rather than heat. This inappropriate activation leads to excessive sweating that can occur even at rest (Schote et al., 2022).

Diagnosis is primarily clinical and based on patient history and visible signs of excessive sweating. Patients often report episodes that are bilateral and symmetrical, with cold and wet palms that may appear pale or blushed. The diagnosis does not typically require extensive testing unless secondary causes are suspected (Henning et al., 2021).

Treatment for palmar hyperhidrosis can be challenging due to varying degrees of severity and individual responses to therapies (Chudry, 2022).

Common treatment options include topical treatments as aluminum chloride hexahydrate which is considered one of the most effective topical treatments for palmar hyperhidrosis. It works by blocking sweat pores and reducing gland activity. Application involves using a concentrated solution on dry skin at night until symptoms improve, followed by maintenance therapy (Rahim et al., 2022).

Another option of treatment is iontophoresis; this technique uses electrical currents to temporarily block sweat gland function. It requires multiple sessions but can be effective for many patients (Nastase et al., 2024).

Botulinum toxin type A can be injected into affected areas to inhibit neurotransmitter release responsible for activating sweat glands. While effective, this treatment requires repeated injections every few months due to its temporary effects (Martina et al., 2021).

Anticholinergic drugs have been used but are often limited by side effects such as dry mouth and constipation at effective dosages (Wong et al., 2022).

The stellate ganglion block (SGB) is a nonsurgical treatment option for managing hyperhidrosis, particularly in cases where other treatments have failed. The stellate ganglion is a collection of nerves located in the neck that plays a crucial role in regulating sweat gland activity. By blocking these nerves, it is possible to reduce sweating in the affected areas (Deng et al., 2023).

The SGB works by injecting local anesthetics into the stellate ganglion, which interrupts the sympathetic nerve signals responsible for activating sweat glands. This procedure can be performed using ultrasound guidance to ensure accurate placement of the needle. The typical approach involves administering an anesthetic such as lidocaine or bupivacaine directly into the ganglion (Feigin et al., 2023).

Regarding surgical options; surgical sympathectomy is considered a last resort for severe cases where other treatments have failed. This procedure involves cutting nerves that trigger sweating but carries risks such as compensatory sweating in other body areas (Kuijpers et al., 2022).

Finally, palmar hyperhidrosis is a common yet often underreported condition that can severely affect individuals' lives due to its social implications and discomfort associated with excessive sweating. Treatment options vary widely in effectiveness and side effects, necessitating a tailored approach based on individual needs (Trettin et al., 2022).

Being tested
Bupivacaine + Lidocaine +dexamethasone, Tryptizole + Librax
Keywords
Stellate ganglion block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine + Lidocaine +dexamethasoneDrug

    Also called xylocaine or bupivacine, lidocaine or marcaine

    Sonar guided block of Stellate Ganglion By Bupivacaine + Lidocaine

  • Tryptizole + LibraxDrug

    Also called Anxiolytics

    Tryptizole + Librax

Study groups in NCT06731101
Study groupRoleWhat they receive
Stellate ganglion blockActive comparatorbupivacaine+ lidocaine + dexamethasone injection into stellate ganglion
Receives: Drug: Bupivacaine + Lidocaine +dexamethasone
DrugsActive comparatorlibrax + tryptizole
Receives: Drug: Tryptizole + Librax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secretions

    i.e. presence/absence of hyperhidrosis

    Measured: 3 months

Secondary outcomes (1)
  1. Compensatory hyperhidrosis

    Increase secretions in other side

    Measured: 1 ]week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start15 Jan 2025
  3. Primary completion10 Dec 2025
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Compare two groups of Palmar hyperhidrosis one with injection Local anesthetic at stellate ganglion, the other will take oral medication
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731101
Sponsor's protocol ID
D401
Status last verified
Feb 2026
First submitted
9 Dec 2024
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine + Lidocaine +dexamethasone and Tryptizole + Librax in people with Palmar Hyperhidrosis, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secretions (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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