Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0065149382
Study information
Scientific title
Low versus high dose Botulinum Toxin A in Axillary Hyperhidrosis
Acronym
Study hypothesis
To compare the efficacy of fewer injections of a higher dose (5U) to the conventional practice of numerous smaller dose (2U) injections. We aim to compare the total amount and area of sweating of these two regimes and their comfort for the patient.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled intra-individual single-blinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Axillary hyperhidrosis
Intervention
Higher dose (5U) vs conventional practice of numerous smaller dose (2U) injections
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Botulinum Toxin A
Primary outcome measure
Patient comparison of the total amount and area of sweating by gravimetric (weighing total amount of sweat) and starch-iodine (demarcating area of sweat) testing respectively between the axillae treated with 2U BTX-A per injection to that treated with 5U BTX-A
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/09/2004
Overall study end date
01/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Approximately 28 patients will be recruited
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2004
Recruitment end date
01/03/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City Hospitals Sunderland NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|