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

NCT01956591 | Completed

• 1 other identifier: HIsraelitaAE
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperhidrosis

Keywords

Treatment efficacy; Long-term effects; Tachyphylaxis; Undesirable effects; Side effects; Self-assessment; Hyperhidrosis; Quality of life

Outcome Measures

Primary Outcomes (2)

• Quality of life

  Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment

  1 day before treatment

• 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

Secondary Outcomes (2)

• Perception of improvement in excessive sweating

  After 42 days of treatment

• Perception of improvement in excessive sweating

  1 day (On the last medical visit)

Other Outcomes (2)

• Side effects in the use of oxybutynin for hyperhidrosis

  After 42 days of treatment

• Side effects in the use of oxybutynin for hyperhidrosis

  1 day )On the last medical visit)

Study Arms (5)

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.

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.

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.

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.

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.

Drug: Oxybutynin

Interventions

Oxybutynin DRUG

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.

Axillary hyperhidrosis; Cranio-facial hyperhidrosis; Other sites hyperhidrosis; Palmar hyperhidrosis; Plantar hyperhidrosis

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patients on two tertiary hospitals (Hospital Israelita Albert Einstein and Hospital das Clínicas - HCFMUSP) who seeked medical attention because of hyperhidrosis.

You may qualify if:

• Primary hyperhidrosis
• At least 180 days of treatment with oxybutynin

You may not qualify if:

• Incomplete medical chart
• Patients with glaucoma

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652000, Brazil

Location

Related Publications (13)

• 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.

  PMID: 23627681 BACKGROUND

• 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.

  PMID: 23590378 BACKGROUND

• Wolosker 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.

  PMID: 23386077 BACKGROUND

• Wolosker 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.

  PMID: 22341836 BACKGROUND

• Wolosker 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.

  PMID: 22023940 BACKGROUND

• Wolosker 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.

  PMID: 21738960 BACKGROUND

• Wolosker 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.

  PMID: 21688168 BACKGROUND

• 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.

  PMID: 23167161 BACKGROUND

• Maillard 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.

  PMID: 21978500 BACKGROUND

• Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. No abstract available.

  PMID: 17954957 BACKGROUND

• Schollhammer 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.

  PMID: 17438194 BACKGROUND

• 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.

  PMID: 17057269 BACKGROUND

• Tupker 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.

  PMID: 16924061 BACKGROUND

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nelson Wolosker, PhD, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-09

Locations

BR (1)