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.
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.
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).
- Conditions
- Palmar Hyperhidrosis
- 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 group | Role | What they receive |
|---|---|---|
| Stellate ganglion block | Active comparator | bupivacaine+ lidocaine + dexamethasone injection into stellate ganglion Receives: Drug: Bupivacaine + Lidocaine +dexamethasone |
| Drugs | Active comparator | librax + tryptizole Receives: Drug: Tryptizole + Librax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secretions
i.e. presence/absence of hyperhidrosis
Measured: 3 months
Secondary outcomes (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.
- First posted12 Dec 2024
- Study start15 Jan 2025
- Primary completion10 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha mohamed agmy, Fayoum University
- Investigators
- Atef M Khalil, professor, Principal investigator, Fayoum University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Stellate Ganglion Block Versus Combined Oral Anticholinergic and Antidepressant Drugs on Treatment of Palmar Hyperhidrosis; A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06731101
- Acronym / sponsor ID
- D401
- Conditions
- Palmar Hyperhidrosis
- Keywords
- Stellate ganglion block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare between ganglion block versus combined oral anticholinergic and antidepressant drugs on treatment of palmar hyperhidrosis
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compare two groups of Palmar hyperhidrosis one with injection Local anesthetic at stellate ganglion, the other will take oral medication
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block | Active comparator | Drug: Bupivacaine + Lidocaine +dexamethasonebupivacaine+ lidocaine + dexamethasone injection into stellate ganglion |
| Drugs | Active comparator | Drug: Tryptizole + Libraxlibrax + tryptizole |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine + Lidocaine +dexamethasoneAlso: xylocaine or bupivacine, lidocaine or marcaineSonar guided block of Stellate Ganglion By Bupivacaine + Lidocaine | Drug | Stellate ganglion block |
| Tryptizole + LibraxAlso: AnxiolyticsTryptizole + Librax | Drug | Drugs |
Primary outcome
Secretions
Time frame: 3 months
i.e. presence/absence of hyperhidrosis
1 secondary outcome
Compensatory hyperhidrosis
Time frame: 1 ]week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef M Khalil, professor principal investigator
Fayoum University
1 site in 1 country: see every site and its status.
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.