HyperhidrosisNCT00004480
Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
A study testing botulinum toxin type A in people with Hyperhidrosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- botulinum toxin type A
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Diagnosis of hyperhidrosis
- Excessive sweating in the hands, feet, armpits, forehead, or body
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
OBJECTIVES:
- Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.
Read the detailed description
PROTOCOL OUTLINE:
Patients receive injections of botulinum toxin in the clinical trial for 6 months. Patients undergo an iodine starch test and a sympathetic skin response test to assess the efficacy of the drug. Patients also complete questionnaires to evaluate the amount of sweating.
- Conditions
- Hyperhidrosis
- Being tested
- botulinum toxin type A
- Keywords
- dermatologic disorders, hyperhidrosis, rare disease
- Medical subject headings
- Hyperhidrosis, Skin Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Horacio Kaufmann, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004480
- Sponsor's protocol ID
- 199/14182
- Other IDs
- MTS-GCO-98-913NE, ALLERGAN-MTS-GCO-98-913NE
- Status last verified
- Jul 2004
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT00004480
- Acronym / sponsor ID
- 199/14182
- Conditions
- Hyperhidrosis
- Keywords
- dermatologic disorders, hyperhidrosis, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 1999
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.
Detailed description
PROTOCOL OUTLINE:
Patients receive injections of botulinum toxin in the clinical trial for 6 months. Patients undergo an iodine starch test and a sympathetic skin response test to assess the efficacy of the drug. Patients also complete questionnaires to evaluate the amount of sweating.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type A | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horacio Kaufmann study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin type A in people with Hyperhidrosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.