Low versus high dose Botulinum Toxin A in Axillary Hyperhidrosis

ISRCTN	ISRCTN05152123
DOI	https://doi.org/10.1186/ISRCTN05152123
Secondary identifying numbers	N0065149382

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr J A A Langtry
Scientific

Department of Dermatology
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

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
Scientific title	Low versus high dose Botulinum Toxin A in Axillary Hyperhidrosis
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Approximately 28 patients will be recruited
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2004
Date of final enrolment	01/03/2006

Sunderland Royal Hospital

Sunderland
SR4 7TP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

City Hospitals Sunderland NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan