Low versus high dose Botulinum Toxin A in Axillary Hyperhidrosis
| ISRCTN | ISRCTN05152123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05152123 |
| Protocol serial number | N0065149382 |
| Sponsor | Department of Health |
| Funder | City Hospitals Sunderland NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 01/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Dr J A A Langtry
Scientific
Scientific
Department of Dermatology
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled intra-individual single-blinded study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum Toxin A |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 28 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
