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Not yet recruitingNCT07788326Updated Aug 26, 2026

20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis

An interventional study of Group A and Group B in Hyperhidrosis, sponsored by Fayoum University Hospital. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

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.

The underlying mechanism involves hyperactivity of the sympathetic nervous system, particularly affecting the eccrine sweat glands located in the palms .

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 .

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.

Treatment for palmar hyperhidrosis can be challenging due to varying degrees of severity and individual responses to therapies.

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.

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.

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 .

Anticholinergic drugs have been used but are often limited by side effects such as dry mouth and constipation at effective dosages .

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.

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.

Read the detailed description

Study tools:

  1. After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.
  2. A total of 50 patients will be categorized into 2 groups:

    • Group A "Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique
    • Group B " Stellate Ganglion Block steroid local anesthetic technique only
  3. Patients will give their consent after having been fully informed about the more frequent side effects of each procedure, such as compensatory sweating and especially those after the block : interscapular pain, transient pneumothorax, and Horner's syndrome.
  4. Objective Sweating Assessment:

    • Patients transferred from dermatology clinic after Diagnosis with primary hyperhidrosis and failed topical treatement.
    • asses severity of sweating by HDSS.
  5. Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique

    • The patient will be placed in the supine position on the operating table.
    • Routine monitoring: pulse oximetet, ABP\&ECG
    • IV canula
    • patient will sedate befoer starring the procedure By "midathetic +fentanyl"
    • support the patient with oxygen By nasal canula sterilized drape will be used to ensure safety. The needle tip will be placed in the stellate ganglion under ultrasound guidance "high frequency linear probe" EG LOGIQ L6-12-RS" Alcohol 20% 2ml, lidocaine" 2% 3ml, Dexamethasone amp 8mg 2ml and 3ml normal saline will be used for Stellate Ganglion Block. inject a total of 10 mL of the mixture.

    Follow up Signs of success of the block as drop of eye lid, redness eye and flushing of half side of the face Follow up hotness and dryness of hand after 1 hour of injection . Follow up after 1 week, injection may be repeated If dryness disappear.

  6. Stellate Ganglion Block steroid local anesthetic technique only

    • The patient will be placed in the supine position on the operating table.
    • Routine monitoring: pulse oximetet, ABP\&ECG
    • IV canula
    • patient will sedate befoer starring the procedure By "midathetic +fentanyl"
    • support the patient with oxygen By nasal canula
    • sterilized drape will be used to ensure safety.
    • The needle tip will be placed in the stellate ganglion under ultrasound guidance "high frequency linear probe" EG LOGIQ L6-12-RS"
    • xylocaine" lidocaine" 2% 3ml, dexamethasone amp 2ml and 5ml normal saline with total of 10ml will be used for Stellate Ganglion Block.
    • Follow up Signs of success of the block as drop of eye lid, redness eye and flushing of half side of the face
    • Follow up hotness and dryness of hand after 1 hour of injection .
    • Follow up after 1 week, injection may be repeated If dryness disappear.
  7. Follow-Up

    Follow-up will include periodical outpatient visits during which all evaluations will be repeated. Owing to rapid response, forefinger temperature will also be determined 1 hour after treatment.

    Follow up for 6 months

  8. Assessment:

    • Presence/absence of hyperhidrosis: Hyperhidrosis Disease Severity scale " HDSS "will be used, involving asking the patients to describe their sweating status before and after treatment.

A score of 1 or 2 will be classified as mild or moderate hyperhidrosis. A score of 3 or 4 will be classified as severe hyper-hidrosis. A 1-point decrease in the patient's sweating scale means a 50% decrease in sweat production, and a 2-point decrease means an 80% decrease in sweat production, a 3-point decrease means about an 90% decrease in sweat production (Solish et al., 2007).

  • Compensatory hyperhidrosis events:classified as no compensatory hyperhidrosis, Mild (i.e., sometimes sweaty and sometimes not sweaty), Moderate (i.e., constantly aware but not troublesome or troublesome but controlled by clothing), and Severe (i.e., causing embarrassment or regret over having undergone endoscopic thoracic sympathectomy) (Purtuloglu et al., 2013).
  • Other outcomes will include patient satisfaction (satisfied or not satisfied), preoperative, intraoperative, and postoperative evaluation of measured hemodynamic parameters, and other complications (i.e., pneumothorax, hematoma, ptosis, muscle weakness, and muscle spasm).
  • A cost comparison between groups concerning devices, drugs, global time in operating room, medical personnel, and hospital stay will also be carried out.

Study outcomes:

  • Primary outcome: hyperhydrosis severity scale i.e. presence/absence of hyperhidrosis.
  • Secondary outcome parameters:

    • Compensatory hyperhidrosis events,
    • Patient satisfaction (satisfied or not satisfied),
    • Preoperative, intraoperative, and postoperative evaluation of measured hemodynamic parameters.

      . Number of injection needed to overcome hyperhydrosis.

    • Complications (i.e., pneumothorax, hematoma, ptosis, muscle weakness, and muscle spasm).
    • Cost.
    • Time in operating room.
    • Hospital stay.

Ethical Consideration:

Participating patients will sign informed written consent after thorough explanation of the details and purpose of the current study.

Patients have the right to withdraw from the study at any phase without being adversely impacted regarding the medical care they should receive.

The study protocol will be approved by the Ethical Research Committee of Anesthesia Department and Faculty of Medicine, Fayoum University.

Confidentiality of data will be maintained by the following:

  • Substitution of codes for information that identifies the participant (e.g., using numbers instead of names to identify participants).
  • Removal of face sheets that contain identifiers, such as names.
  • Files containing electronic data will be password-protected and encrypted (at least when data were transferred or transported) and closed when computers will be left unattended.
  • Limited access to all data that identifies participants.
  • Paper records will be stored in locked cabinets.
  • Consents will be stored securely in locked cabinets, separately from the research data.
  • Proper disposal of all paper documents that contain identifiers .Statistical analysis and statistical package:

Data will screen, for normality assumption test and homogeneity of variance, normality test of data using Kolmogorov Smirnov test will use, that reflect the data is normally distributed or non-normally distributed after removal outliers that detect by box and whiskers plots. All these findings will allow conducting parametric or non-parametric analysis. The statistical analysis will conduct by using statistical SPSS Package program version 25 for Windows (SPSS, Inc., Chicago, IL). The following statistical procedures will perform for:

  1. Parametric data will express as the mean and standard deviation (SD) for major variables. Independent (unpaired) t-test will use to compare between both groups (misoprostol group vs. lidocaine spray group) for major outcome variables.
  2. Non-parametric data will express as the median and interquartile range (IQR) for major variables. Mann-Whitney U test will use to compare between both groups (misoprostol group vs. lidocaine spray group) for major outcome variables.
  3. Statistical level all statistical analyses for parametric and non-parametric data are significant at level of probability less than an equal 0.05 (P ≤ 0.05).
02

Conditions studied

  • Hyperhidrosis

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Keywords

  • idiopathic palmoplantar hyperhidrosis
  • stellate ganglion injection
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age from 18 to 45 years.
  2. Both genders.
  3. Exhibiting primary palmar hyperhidrosis.
  4. All patients with hyperhidrosis and were socially, professionally, and psychologically handicapped.
  5. All patients with failed previous dermatological topical treatment as aluminum chloride hexahydrate

Exclusion criteria

Exclusion Criteria:

  1. An inability of patient to cooperate.
  2. Known allergies to alcohol or local anaesthetic.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique

    Procedure: Group A

  • Active comparator
    Stellate Ganglion Block steroid local anesthetic technique only

    Procedure: Group B

Interventions

  • ProcedureGroup A

    The aim of the study is to compare between 20% alcohol with steroid local anesthetic technique versus steroid local anesthetic technique only in stellate ganglion injection in treatment of idiopathic palmoplantar hyperhidrosis.

  • ProcedureGroup B

    The aim of the study is to compare between 20% alcohol with steroid local anesthetic technique versus steroid local anesthetic technique only in stellate ganglion injection in treatment of idiopathic palmoplantar hyperhidrosis.

06

What researchers measure

Primary outcomes

  1. hyperhydrosis severity scale

    presence/absence of hyperhidrosis

    Time frame: After 1 hour of injection

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ambrogi V, Campione E, Mineo D, Paterno EJ, Pompeo E, Mineo TC. Bilateral thoracoscopic T2 to T3 sympathectomy versus botulinum injection in palmar hyperhidrosis. Ann Thorac Surg. 2009 Jul;88(1):238-45. doi: 10.1016/j.athoracsur.2009.04.003. PubMed 19559233 ↗
  • Choi HG, Kwon SY, Won JY, Yoo SW, Lee MG, Kim SW, Park B. Comparisons of Three Indicators for Frey's Syndrome: Subjective Symptoms, Minor's Starch Iodine Test, and Infrared Thermography. Clin Exp Otorhinolaryngol. 2013 Dec;6(4):249-53. doi: 10.3342/ceo.2013.6.4.249. Epub 2013 Nov 29. PubMed 24353866 ↗
  • Chudry H. The treatment of palmar hyperhidrosis - a systematic review. Int J Dermatol. 2022 Nov;61(11):1303-1310. doi: 10.1111/ijd.15937. Epub 2021 Oct 15. PubMed 34653261 ↗
  • Henning MAS, Thorlacius L, Ibler KS, Jemec GBE. How to diagnose and measure primary hyperhidrosis: a systematic review of the literature. Clin Auton Res. 2021 Aug;31(4):511-528. doi: 10.1007/s10286-021-00794-6. Epub 2021 Mar 27. PubMed 33772671 ↗
  • Kisielnicka A, Szczerkowska-Dobosz A, Purzycka-Bohdan D, Nowicki RJ. 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. PubMed 35645673 ↗
  • Kuijpers M, van Zanden JE, Harms PW, Mungroop HE, Mariani MA, Klinkenberg TJ, Bouma W. Minimally Invasive Sympathicotomy for Palmar Hyperhidrosis and Facial Blushing: Current Status and the Hyperhidrosis Expert Center Approach. J Clin Med. 2022 Jan 31;11(3):786. doi: 10.3390/jcm11030786. PubMed 35160238 ↗
  • Martina E, Diotallevi F, Radi G, Campanati A, Offidani A. Therapeutic Use of Botulinum Neurotoxins in Dermatology: Systematic Review. Toxins (Basel). 2021 Feb 5;13(2):120. doi: 10.3390/toxins13020120. PubMed 33562846 ↗
  • Nastase F, Busila C, Nicolescu AC, Marin CM, Tatu AL. Iontophoresis Improves the Impact on the Quality of Life of Children with Primary Hyperhidrosis-A Prospective Study and a Short Review. Children (Basel). 2024 Oct 17;11(10):1253. doi: 10.3390/children11101253. PubMed 39457218 ↗
  • Purtuloglu T, Atim A, Deniz S, Kavakli K, Sapmaz E, Gurkok S, Kurt E, Turan A. Effect of radiofrequency ablation and comparison with surgical sympathectomy in palmar hyperhidrosis. Eur J Cardiothorac Surg. 2013 Jun;43(6):e151-4. doi: 10.1093/ejcts/ezt024. Epub 2013 Feb 21. PubMed 23428574 ↗
  • Rahim M, Ahmed N, Naz Khan K, Memon S, Naveed T, Shah SA, Farooq O, Ali U. 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. PubMed 36627989 ↗
  • Schote AB, Dietrich K, Linden AE, Dzionsko I, Molano Moreno LLA, Winnikes U, Zimmer P, Domes G, Meyer J. Real sweating in a virtual stress environment: Investigation of the stress reactivity in people with primary focal hyperhidrosis. PLoS One. 2022 Aug 2;17(8):e0272247. doi: 10.1371/journal.pone.0272247. eCollection 2022. PubMed 35917298 ↗
  • Solish MJ, Savinova I, Weinberg MJ. A Practical Approach to the Diagnosis and Treatment of Palmar Hyperhidrosis. Plast Reconstr Surg Glob Open. 2022 Mar 7;10(3):e4172. doi: 10.1097/GOX.0000000000004172. eCollection 2022 Mar. PubMed 35265447 ↗
  • Solish N, Bertucci V, Dansereau A, Hong HC, Lynde C, Lupin M, Smith KC, Storwick G; Canadian Hyperhidrosis Advisory Committee. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007 Aug;33(8):908-23. doi: 10.1111/j.1524-4725.2007.33192.x. PubMed 17661933 ↗
  • Trettin B, Hansen J, Bygum A. The impact of adolescents' everyday life experiences on their primary hyperhidrosis treatment - a qualitative study. J Dermatolog Treat. 2022 Mar;33(2):928-934. doi: 10.1080/09546634.2020.1789541. Epub 2020 Jul 22. PubMed 32628056 ↗
  • Wadhawa S, Agrawal S, Chaudhary M, Sharma S. Hyperhidrosis Prevalence: A Disease Underreported by Patients and Underdiagnosed by Physicians. Indian Dermatol Online J. 2019 Nov 1;10(6):676-681. doi: 10.4103/idoj.IDOJ_55_19. eCollection 2019 Nov-Dec. PubMed 31807447 ↗
  • Wong NS, Adlam TM, Potts GA, Farshchian M. Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics. Dermatol Ther (Heidelb). 2022 Dec;12(12):2705-2714. doi: 10.1007/s13555-022-00838-3. Epub 2022 Nov 3. PubMed 36329359 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07788326
Lead sponsor
Fayoum University Hospital
Responsible party
Atef Mohamed mahmoud (Associated Professor, Fayoum University Hospital) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Ahmed S Abdalla, M.Sc
Contact
asa43@fayoum.edu.eg
1069291684 ext. +20
Atef M Sayed, MD
Contact
amk04@fayoum.edu.eg
10 03973883 ext. +20
Atef M Sayed, MD
principal investigator · Faculty of medicine, Fayoum university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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