HyperhidrosisNCT01956591
Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis
An observational study of Hyperhidrosis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Oxybutynin
- How many people
- 1,100 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to Sep 2013
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Out-patients on two tertiary hospitals (Hospital Israelita Albert Einstein and Hospital das Clínicas - HCFMUSP) who seeked medical attention because of hyperhidrosis.
Who may be able to join
- Primary hyperhidrosis
- At least 180 days of treatment with oxybutynin
Who cannot join
- Incomplete medical chart
- Patients with glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis
Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.
Read the detailed description
This retrospective study aims to evaluate the medical charts of patients who were treated with oxybutynin for at least six months for primary hyperhidrosis. The investigators variables of interest are: (1) quality of life before pharmacological therapy and after six weeks, (2)self-perception of improvement in hyperhidrosis after six weeks of treatment and on last visit (whenever this occur, as long as this happens after six months), (3) side effects related to drug use.
- Conditions
- Hyperhidrosis
- Being tested
- Oxybutynin
- Keywords
- Treatment efficacy, Long-term effects, Tachyphylaxis, Undesirable effects, Side effects, Self-assessment, Hyperhidrosis, Quality of life
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
| Study group | Role | What they receive |
|---|---|---|
| Axillary hyperhidrosis | Patients whose major complaint is excessive sweating in the axillary region (i.e, sweating in the armpit). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., palmar hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. Receives: Drug: Oxybutynin | |
| Palmar hyperhidrosis | Patients whose major complaint is excessive sweating in the palmar region (i.e, sweating in the hands). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. Receives: Drug: Oxybutynin | |
| Plantar hyperhidrosis | Patients whose major complaint is excessive sweating in the plantar region (i.e, sweating in the feet). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. Receives: Drug: Oxybutynin | |
| Cranio-facial hyperhidrosis | Patients whose major complaint is excessive sweating in the cranio-facial region (i.e, sweating in the face). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. Receives: Drug: Oxybutynin | |
| Other sites hyperhidrosis | Patients whose major complaint is excessive sweating in other sites of the body (e.g., on the chest, on the abdomen). Patients that also have hyperhidrosis - but that are less bothersome on other sites previously grouped (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. Receives: Drug: Oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment
Measured: 1 day before treatment
Quality of life
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment
Measured: Forty-two days after treatment
Secondary outcomes (2)
Perception of improvement in excessive sweating
We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating after forty-two days of treatment
Measured: After 42 days of treatment
Perception of improvement in excessive sweating
We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating on the last medical visit (whenever this happens).
Measured: 1 day (On the last medical visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2007
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Wolosker, Hospital Israelita Albert Einstein
- Investigators
- Nelson Wolosker, PhD, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956591
- Sponsor's protocol ID
- HIsraelitaAE
- Status last verified
- Sep 2013
- First submitted
- 16 Aug 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolosker N, Schvartsman C, Krutman M, Campbell TP, Kauffman P, de Campos JR, Puech-Leao P. Efficacy and quality of life outcomes of oxybutynin for treating palmar hyperhidrosis in children younger than 14 years old. Pediatr Dermatol. 2014 Jan-Feb;31(1):48-53. doi: 10.1111/pde.12142. Epub 2013 Apr 29.
PubMed 23627681Wolosker N, de Campos JR, Kauffman P, Yazbek G, Neves S, Puech-Leao P. Use of oxybutynin for treating plantar hyperhidrosis. Int J Dermatol. 2013 May;52(5):620-3. doi: 10.1111/j.1365-4632.2012.05746.x.
PubMed 23590378Wolosker N, Krutman M, Campdell TP, Kauffman P, Campos JR, Puech-Leao P. Oxybutynin treatment for hyperhidrosis: a comparative analysis between genders. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):405-8. doi: 10.1590/s1679-45082012000400002. English, Portuguese.
PubMed 23386077Wolosker N, de Campos JR, Kauffman P, Puech-Leao P. A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. J Vasc Surg. 2012 Jun;55(6):1696-700. doi: 10.1016/j.jvs.2011.12.039. Epub 2012 Feb 16.
PubMed 22341836Wolosker N, de Campos JR, Kauffman P, Neves S, Munia MA, BiscegliJatene F, Puech-Leao P. The use of oxybutynin for treating axillary hyperhidrosis. Ann Vasc Surg. 2011 Nov;25(8):1057-62. doi: 10.1016/j.avsg.2011.06.007.
PubMed 22023940Wolosker N, Campos JR, Kauffman P, Munia MA, Neves S, Jatene FB, Puech-Leao P. The use of oxybutynin for treating facial hyperhidrosis. An Bras Dermatol. 2011 May-Jun;86(3):451-6. doi: 10.1590/s0365-05962011000300005.
PubMed 21738960Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, Puech-Leao P. An alternative to treat palmar hyperhidrosis: use of oxybutynin. Clin Auton Res. 2011 Dec;21(6):389-93. doi: 10.1007/s10286-011-0128-4. Epub 2011 Jun 19.
PubMed 21688168Try C, Messikh R, Elkhyat A, Aubin F, Humbert RP. [Use of oral oxybutynin at 7.5 mg per day in primary hyperhidrosis]. Rev Med Liege. 2012 Oct;67(10):520-6. French.
PubMed 23167161Maillard H, Fenot M, Bara C, Celerier P. [Therapeutic value of moderate-dose oxybutynin in extensive hyperhidrosis]. Ann Dermatol Venereol. 2011 Oct;138(10):652-6. doi: 10.1016/j.annder.2011.07.002. Epub 2011 Aug 17. French.
PubMed 21978500Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. No abstract available.
PubMed 17954957Schollhammer M, Misery L. Treatment of hyperhidrosis with oxybutynin. Arch Dermatol. 2007 Apr;143(4):544-5. doi: 10.1001/archderm.143.4.544. No abstract available.
PubMed 17438194Mijnhout GS, Kloosterman H, Simsek S, Strack van Schijndel RJ, Netelenbos JC. Oxybutynin: dry days for patients with hyperhidrosis. Neth J Med. 2006 Oct;64(9):326-8.
PubMed 17057269Tupker RA, Harmsze AM, Deneer VH. Oxybutynin therapy for generalized hyperhidrosis. Arch Dermatol. 2006 Aug;142(8):1065-6. doi: 10.1001/archderm.142.8.1065. No abstract available.
PubMed 16924061
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01956591
- Acronym / sponsor ID
- HIsraelitaAE
- Conditions
- Hyperhidrosis
- Keywords
- Treatment efficacy, Long-term effects, Tachyphylaxis, Undesirable effects, Side effects, Self-assessment, Hyperhidrosis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Oct 2013 (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.
Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.
Detailed description
This retrospective study aims to evaluate the medical charts of patients who were treated with oxybutynin for at least six months for primary hyperhidrosis. The investigators variables of interest are: (1) quality of life before pharmacological therapy and after six weeks, (2)self-perception of improvement in hyperhidrosis after six weeks of treatment and on last visit (whenever this occur, as long as this happens after six months), (3) side effects related to drug use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Axillary hyperhidrosis | – | Drug: OxybutyninPatients whose major complaint is excessive sweating in the axillary region (i.e, sweating in the armpit). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., palmar hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
| Palmar hyperhidrosis | – | Drug: OxybutyninPatients whose major complaint is excessive sweating in the palmar region (i.e, sweating in the hands). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
| Plantar hyperhidrosis | – | Drug: OxybutyninPatients whose major complaint is excessive sweating in the plantar region (i.e, sweating in the feet). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
| Cranio-facial hyperhidrosis | – | Drug: OxybutyninPatients whose major complaint is excessive sweating in the cranio-facial region (i.e, sweating in the face). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
| Other sites hyperhidrosis | – | Drug: OxybutyninPatients whose major complaint is excessive sweating in other sites of the body (e.g., on the chest, on the abdomen). Patients that also have hyperhidrosis - but that are less bothersome on other sites previously grouped (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out-patients on two tertiary hospitals (Hospital Israelita Albert Einstein and Hospital das Clínicas - HCFMUSP) who seeked medical attention because of hyperhidrosis.
Key inclusion criteria (2 listed)
- Primary hyperhidrosis
- At least 180 days of treatment with oxybutynin
Key exclusion criteria (2 listed)
- Incomplete medical chart
- Patients with glaucoma
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 |
|---|---|---|
| OxybutyninAll patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards. | Drug | Axillary hyperhidrosis, Cranio-facial hyperhidrosis, Other sites hyperhidrosis, Palmar hyperhidrosis, Plantar hyperhidrosis |
Primary outcome
Quality of life
Time frame: 1 day before treatment
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment
Quality of life
Time frame: Forty-two days after treatment
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment
2 secondary outcomes
Perception of improvement in excessive sweating
Time frame: After 42 days of treatment
Perception of improvement in excessive sweating
Time frame: 1 day (On the last medical visit)
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 8 Oct 2013.
- Background: PubMed 23627681Wolosker N, Schvartsman C, Krutman M, Campbell TP, Kauffman P, de Campos JR, Puech-Leao P. Efficacy and quality of life outcomes of oxybutynin for treating palmar hyperhidrosis in children younger than 14 years old. Pediatr Dermatol. 2014 Jan-Feb;31(1):48-53. doi: 10.1111/pde.12142. Epub 2013 Apr 29.
- Background: PubMed 23590378Wolosker N, de Campos JR, Kauffman P, Yazbek G, Neves S, Puech-Leao P. Use of oxybutynin for treating plantar hyperhidrosis. Int J Dermatol. 2013 May;52(5):620-3. doi: 10.1111/j.1365-4632.2012.05746.x.
- Background: PubMed 23386077Wolosker N, Krutman M, Campdell TP, Kauffman P, Campos JR, Puech-Leao P. Oxybutynin treatment for hyperhidrosis: a comparative analysis between genders. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):405-8. doi: 10.1590/s1679-45082012000400002. English, Portuguese.
- Background: PubMed 22341836Wolosker N, de Campos JR, Kauffman P, Puech-Leao P. A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. J Vasc Surg. 2012 Jun;55(6):1696-700. doi: 10.1016/j.jvs.2011.12.039. Epub 2012 Feb 16.
- Background: PubMed 22023940Wolosker N, de Campos JR, Kauffman P, Neves S, Munia MA, BiscegliJatene F, Puech-Leao P. The use of oxybutynin for treating axillary hyperhidrosis. Ann Vasc Surg. 2011 Nov;25(8):1057-62. doi: 10.1016/j.avsg.2011.06.007.
- Background: PubMed 21738960Wolosker N, Campos JR, Kauffman P, Munia MA, Neves S, Jatene FB, Puech-Leao P. The use of oxybutynin for treating facial hyperhidrosis. An Bras Dermatol. 2011 May-Jun;86(3):451-6. doi: 10.1590/s0365-05962011000300005.
- Background: PubMed 21688168Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, Puech-Leao P. An alternative to treat palmar hyperhidrosis: use of oxybutynin. Clin Auton Res. 2011 Dec;21(6):389-93. doi: 10.1007/s10286-011-0128-4. Epub 2011 Jun 19.
- Background: PubMed 23167161Try C, Messikh R, Elkhyat A, Aubin F, Humbert RP. [Use of oral oxybutynin at 7.5 mg per day in primary hyperhidrosis]. Rev Med Liege. 2012 Oct;67(10):520-6. French.
- Background: PubMed 21978500Maillard H, Fenot M, Bara C, Celerier P. [Therapeutic value of moderate-dose oxybutynin in extensive hyperhidrosis]. Ann Dermatol Venereol. 2011 Oct;138(10):652-6. doi: 10.1016/j.annder.2011.07.002. Epub 2011 Aug 17. French.
- Background: PubMed 17954957Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. No abstract available.
- Background: PubMed 17438194Schollhammer M, Misery L. Treatment of hyperhidrosis with oxybutynin. Arch Dermatol. 2007 Apr;143(4):544-5. doi: 10.1001/archderm.143.4.544. No abstract available.
- Background: PubMed 17057269Mijnhout GS, Kloosterman H, Simsek S, Strack van Schijndel RJ, Netelenbos JC. Oxybutynin: dry days for patients with hyperhidrosis. Neth J Med. 2006 Oct;64(9):326-8.
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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.
Nelson Wolosker, PhD, MD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperhidrosis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 8 Oct 2013. 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 Brazil. 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.
What does the primary outcome measure?
Quality of life (time frame: 1 day before treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956591, which also lists 13 linked publications.
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 8 Oct 2013.