Assessing the Effect of Patient Characteristics on Treatment Response in Primary Hyperhidrosis

NCT03694093 | Completed

• 1 other identifier: 29446
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study will describe the treatment of hyperhidrosis (excessive sweating) in clinical practice and explore the effect of patient characteristics on treatment response. This study will follow 200 people with hyperhidrosis over 18 months. Anyone with primary hyperhidrosis (excessive sweating not due to another medical condition) over the age of 12 may participate. Study participants will have multiple office visits during which they will asked to rate the severity of their sweat production in multiple areas (i.e. underarms, hands, feet), answer a questionnaire regarding their disease and treatment, and undergo a non-invasive measurement of sweat production called gravimetry. Gravimetry is performed by placing absorbent material in an area, such as the underarms, for a set amount of time and then measuring the amount of sweat collected. In between clinic visits, study participants will be contacted electronically to answer several questions regarding their disease and treatment.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Weeks till treatment response

  We will measure the weeks required to reach treatment response defined as HDSS of 1 or 2.

  18 months

Secondary Outcomes (4)

• Number of treatment changes

  18 months

• Number of treatments at the time of treatment response.

  18 months

• Percent reduction in gravimetric sweat measurements

  18 months

• Disease impact

  18 months

Study Arms (1)

Patients with Hyperhidrosis

Subjects with Primary Hyperhidrosis will be followed in this study. Because this study is observational, there will be no intervention.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or Females ≥ 12 with Primary Hyperhidrosis.

You may qualify if:

• Male or female of any race who has received the diagnosis of primary Hyperhidrosis at any site
• Patients receiving continued treatment of primary Hyperhidrosis with baseline gravimetrics (established patients only) performed at SLUCare Dermatology Des Peres clinic. Baseline gravimetrics are defined as measurements taken during times of no active disease interventions.

You may not qualify if:

• Received the following therapies at the site being evaluated prior to baseline gravimetrics:
• Botulinum toxin injections 6 months prior to baseline gravimetric data collection.
• Applied Aluminum chloride on day of baseline gravimetric data
• Ongoing iontophoresis therapy at time of baseline gravimetric data
• Oral systemic anticholinergics 4 weeks prior to baseline gravimetric data
• Received surgical intervention, suction and curettage, microwave thermolysis, or ultrasound therapy prior to baseline gravimetrics.
• Patient has received diagnosis of secondary hyperhidrosis (i.e hyperhidrosis due to an underlying medical condition such as hyperthyroidism)
• Younger than 12 years of age.
• Does not desire study participation or is unable to consent.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63131, United States

Location

Related Publications (13)

• Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.

  PMID: 15280848 BACKGROUND

• Glaser DA, Ballard AM, Hunt NL, Pieretti LJ, Pariser DM. Prevalence of Multifocal Primary Hyperhidrosis and Symptom Severity Over Time: Results of a Targeted Survey. Dermatol Surg. 2016 Dec;42(12):1347-1353. doi: 10.1097/DSS.0000000000000949.

  PMID: 27879523 BACKGROUND

• Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016 Dec;308(10):743-749. doi: 10.1007/s00403-016-1697-9. Epub 2016 Oct 15.

  PMID: 27744497 BACKGROUND

• Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.

  PMID: 18795920 BACKGROUND

• Iwase S, Ikeda T, Kitazawa H, Hakusui S, Sugenoya J, Mano T. Altered response in cutaneous sympathetic outflow to mental and thermal stimuli in primary palmoplantar hyperhidrosis. J Auton Nerv Syst. 1997 Jun 6;64(2-3):65-73. doi: 10.1016/s0165-1838(97)00014-3.

  PMID: 9203126 BACKGROUND

• Bovell DL, Clunes MT, Elder HY, Milsom J, Jenkinson DM. Ultrastructure of the hyperhidrotic eccrine sweat gland. Br J Dermatol. 2001 Aug;145(2):298-301. doi: 10.1046/j.1365-2133.2001.04351.x.

  PMID: 11531796 BACKGROUND

• Kowalski JW, Eadie N, Dagget S, Lai P-Y. Validity and reliability of the hyperhidrosis disease severity scale (HDSS). J Am Acad Dermatol 2004;50(3):P51.

  BACKGROUND

• Hoorens I, Ongenae K. Primary focal hyperhidrosis: current treatment options and a step-by-step approach. J Eur Acad Dermatol Venereol. 2012 Jan;26(1):1-8. doi: 10.1111/j.1468-3083.2011.04173.x. Epub 2011 Jul 13.

  PMID: 21749468 BACKGROUND

• Benson RA, Palin R, Holt PJ, Loftus IM. Diagnosis and management of hyperhidrosis. BMJ. 2013 Nov 25;347:f6800. doi: 10.1136/bmj.f6800. No abstract available.

  PMID: 24277380 BACKGROUND

• Solish N, Bertucci V, Dansereau A, Hong HC, Lynde C, Lupin M, Smith KC, Storwick G; Canadian Hyperhidrosis Advisory Committee. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007 Aug;33(8):908-23. doi: 10.1111/j.1524-4725.2007.33192.x.

  PMID: 17661933 BACKGROUND

• Wolosker N, Teivelis MP, Krutman M, de Paula RP, de Campos JR, Kauffman P, Puech-Leao P. Long-term results of oxybutynin treatment for palmar hyperhidrosis. Clin Auton Res. 2014 Dec;24(6):297-303. doi: 10.1007/s10286-014-0264-8. Epub 2014 Nov 27.

  PMID: 25427685 BACKGROUND

• Wolosker N, Krutman M, Teivelis MP, Paula RP, Kauffman P, Campos JR, Puech-Leao P. Analysis of oxybutynin treatment for hyperhidrosis in patients aged over 40 years. Einstein (Sao Paulo). 2014 Jan-Mar;12(1):42-7. doi: 10.1590/s1679-45082014ao2841.

  PMID: 24728245 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

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Dee A Glaser, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chair, Department of Dermatology

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: August 20, 2018
• Primary Completion: August 12, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)