A Study to Compare Oxybutynin to a Placebo in Women and the Effect on Plantar Hyperhidrosis

NCT01328015 | Completed Phase 2 DMC

• 1 other identifier: Oxybutynin and Hyperhidrosis
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study in which the experimental treatment procedure is compared to a standard (control) treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:

1. 1.To Evaluate the effect of oxybutynin on plantar hyperhidrosis.
2. 2.To evaluate the effect of oxybutynin in compensatory hyperhidrosis.
3. 3.To compare the results of questionnaires on quality of life and specific for hyperhidrosis to the results of TEWL.

Conditions

Hyperhidrosis

Keywords

hyperhidrosis; oxybutynin; plantar sweating; compensatory sweating

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of oxybutynin in plantar hyperhidrosis

  Apply the questionnaires of quality of life, specific ones for hyperhidrosis and TEWL before in patients with persistence of plantar sweating after thoracic sympathectomy. After continuous use of oxybutynin for a month, repeated them for comparison.

  60 days

Secondary Outcomes (1)

• To evaluate the effect of oxybutynin in compensatory hyperhidrosis

  60 days

Study Arms (2)

Oxybuynin, hyperhidrosis

ACTIVE COMPARATOR

Drug: Oxybutynin 5 mg pills

placebo - sugar pill

PLACEBO COMPARATOR

Drug: Oxybutynin 5 mg pills

Interventions

Oxybutynin 5 mg pills DRUG

½ pill oral 12/12h for 3 days 01 ½ pills oral morning and evening for 3 days Continue 1 pill oral 2x/day for three weeks.

Also known as: anticholinergic drugs

Oxybuynin, hyperhidrosis; placebo - sugar pill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with persistent plantar hyperhidrosis with limitation to their usual activities.

You may not qualify if:

• pregnancy,
• breastfeeding,
• glaucoma,
• use of tricyclic medications,
• prior use of anticholinergic
• side effects exacerbated, such as diarrhea, gastritis, constipation or dry mouth.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (3)

• 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

• 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

• Costa Ada S Jr, Leao LE, Succi JE, Perfeito JA, Filho Castelo A, Rymkiewicz E, Filho Aurelio Marchetti M. Randomized trial - oxybutynin for treatment of persistent plantar hyperhidrosis in women after sympathectomy. Clinics (Sao Paulo). 2014 Feb;69(2):101-5. doi: 10.6061/clinics/2014(02)05.

  PMID: 24519200 DERIVED

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutynin; Cholinergic Antagonists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Altair S Costa Jr, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 4, 2011
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 4, 2011

Record last verified: 2010-11