NCT03433859 (SALUTOX) is a Phase 3 clinical trial of OnabotulinumtoxinA in Hyperhidrosis, sponsored by Direction Centrale du Service de Santé des Armées.

Who is sponsoring NCT03433859?

NCT03433859 is sponsored by Direction Centrale du Service de Santé des Armées.

What drugs are being tested in NCT03433859?

Interventions in NCT03433859: OnabotulinumtoxinA, Topical Aluminium Chloride (cosmetic product).

What condition does NCT03433859 study?

NCT03433859 studies Hyperhidrosis, Residual Limbs.

Is NCT03433859 still recruiting?

NCT03433859 is currently completed. Last updated 26 April 2021.

Last reviewed 2021-04-26 · How we verify

NCT03433859: SALUTOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

Completed Phase 3 Last updated 26 April 2021

What this trial tests

Phase 3 trial testing OnabotulinumtoxinA in Hyperhidrosis in 54 participants. Completed in 3 March 2021.

Timeline

1 March 2016

Primary endpoint
10 September 2020

3 March 2021

Quick facts

Lead sponsor	Direction Centrale du Service de Santé des Armées
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 March 2016
Primary completion	10 September 2020
Estimated completion	3 March 2021
Sites	9 locations across France

Drugs / interventions tested

OnabotulinumtoxinA (ONABOTULINUMTOXINA) — full drug profile →
Topical Aluminium Chloride (cosmetic product)

Conditions studied

Hyperhidrosis — all drugs for Hyperhidrosis →
Residual Limbs — all drugs for Residual Limbs →

Sponsor

Direction Centrale du Service de Santé des Armées — full company profile →

Who can join

Adults 18 to 75, any sex, with Hyperhidrosis or Residual Limbs. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Hyperhidrosis Disease Severity Score (HDSS) evolution
Time frame: 24 weeks
HDSS score : min 1 - max. 4 * Efficacy : HDSS evolution from 2 (initial measure) to 1 (final measure), from 3 (initial measure) to 1 or 2 (final measure), from 4 (initial measure) to 1 or 2 (final measure) * Failure : from 2 (initial measure) to 2 (final measure), from 3 or 4 (initial measure) to 2 (final measure) ; or increase of HDSS between initial and final measure

Sponsor's own description

The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Hyperhidrosis Clinical Trial Disparities: Enrollment and Reporting Trends.
Gawey L, Joshi A, Dagenet CB, Price KN, et al · · 2025 · PMID 40539206 · DOI 10.1159/000546318

Verify or expand the search:

Other trials of OnabotulinumtoxinA

Trials testing the same drug.

NCT07220382 — Preoperative BOTOX® Injection for Large Ventral Hernia Repair · Phase 4 · recruiting
NCT06834789 — A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participa · Phase 1 · completed
NCT06783621 — A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of Onabotuli · Phase 4 · completed
NCT06530524 — Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery · Phase 2 · not yet recruiting
NCT06499688 — A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatme · Phase 3 · completed

Other recruiting trials for Hyperhidrosis

Currently open trials in the same condition.

NCT05805696 — Treatment and Mapping of Impostor Phenomenon · NA · recruiting
NCT05102396 — Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect? · Phase 2 · recruiting
NCT05403710 — Botulinum Toxin Therapy in Hidradenitis Suppurativa · recruiting

Other Direction Centrale du Service de Santé des Armées trials

Trials by the same sponsor.

NCT07352904 — Exploration Strategies in Night Vision Sensors · not yet recruiting
NCT07344493 — Average ANKLE GO Score in the Objective Functional Assessment of the Ankle in Healthy Military Personnel (ANKMIL) · completed
NCT06996275 — Attachment and Post-Traumatic Stress Disorder in Military Personnel: Characterization of the French Military Population, · not yet recruiting
NCT06490029 — Diagnostic of Various Ototoxicity Induced by Cancer Treatment · recruiting
NCT06174181 — Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degenerat · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03433859 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Direction Centrale du Service de Santé des Armées
Last refreshed: 26 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03433859.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing