Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956591
• Other study ID #: HIsraelitaAE
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: October 7, 2013
• Start date: September 2007
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Primary hyperhidrosis

• At least 180 days of treatment with oxybutynin

Exclusion Criteria:

• Incomplete medical chart

• Patients with glaucoma

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• Oxybutynin
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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. — View Citation

Maillard H, Fenot M, Bara C, Célérier 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. — View Citation

Mijnhout 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. Review. — View Citation

Schollhammer M, Misery L. Treatment of hyperhidrosis with oxybutynin. Arch Dermatol. 2007 Apr;143(4):544-5. — View Citation

Try 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. — View Citation

Tupker RA, Harmsze AM, Deneer VH. Oxybutynin therapy for generalized hyperhidrosis. Arch Dermatol. 2006 Aug;142(8):1065-6. — View Citation

Wolosker N, Campos JR, Kauffman P, Munia MA, Neves S, Jatene FB, Puech-Leão P. The use of oxybutynin for treating facial hyperhidrosis. An Bras Dermatol. 2011 May-Jun;86(3):451-6. — View Citation

Wolosker N, de Campos JR, Kauffman P, Neves S, Munia MA, BiscegliJatene F, Puech-Leão 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. — View Citation

Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, Puech-Leão 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. — View Citation

Wolosker N, de Campos JR, Kauffman P, Puech-Leão 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. — View Citation

Wolosker 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. — View Citation

Wolosker N, Krutman M, Campdell TP, Kauffman P, Campos JR, Puech-Leão P. Oxybutynin treatment for hyperhidrosis: a comparative analysis between genders. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):405-8. English, Portuguese. — View Citation

Wolosker N, Schvartsman C, Krutman M, Campbell TP, Kauffman P, de Campos JR, Puech-Leão 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects in the use of oxybutynin for hyperhidrosis	Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported	After 42 days of treatment	Yes
Other	Side effects in the use of oxybutynin for hyperhidrosis	Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported on the last medical return of the patient	1 day )On the last medical visit)	Yes
Primary	Quality of life	Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment	1 day before treatment	No
Primary	Quality of life	Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment	Forty-two days after treatment	No
Secondary	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	After 42 days of treatment	No
Secondary	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).	1 day (On the last medical visit)	No