Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J A A Langtry

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Botulinum Toxin A

Primary outcome measures

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 trial start date

01/09/2004

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes