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Trial record 15 of 166 for:    "Sweat Gland Disease"

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

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ClinicalTrials.gov Identifier: NCT03694093
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dee Anna Glaser, MD, St. Louis University

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.

Condition or disease
Hyperhidrosis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study Assessing the Effect of Patient Characteristics on Treatment Response in Hyperhidrosis
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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



Primary Outcome Measures :
  1. Weeks till treatment response [ Time Frame: 18 months ]
    We will measure the weeks required to reach treatment response defined as HDSS of 1 or 2.


Secondary Outcome Measures :
  1. Number of treatment changes [ Time Frame: 18 months ]
    We will quantify the number of failed treatment prior to treatment response.

  2. Number of treatments at the time of treatment response. [ Time Frame: 18 months ]
    We will quantify the number of treatments a subject is currently using at the time of treatment response.

  3. Percent reduction in gravimetric sweat measurements [ Time Frame: 18 months ]
    We will quantify the percent reduction in gravimetric sweat measurements from initial visit compared to after treatment response is achieved.

  4. Disease impact [ Time Frame: 18 months ]
    We will track the disease impact through questionnaire responses throughout the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or Females ≥ 12 with Primary Hyperhidrosis.
Criteria

Inclusion Criteria:

  1. Male or female of any race who has received the diagnosis of primary Hyperhidrosis at any site
  2. 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.

Exclusion Criteria:

  1. Received the following therapies at the site being evaluated prior to baseline gravimetrics:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694093


Contacts
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Contact: Mitchell S Gibbons, BA 314-256-3435 dermresearch@health.slu.edu

Locations
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United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Mitchell Gibbons, BA         
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Dee A Glaser, MD St. Louis University

Publications:
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.

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Responsible Party: Dee Anna Glaser, MD, Interim Chair, Department of Dermatology, St. Louis University
ClinicalTrials.gov Identifier: NCT03694093     History of Changes
Other Study ID Numbers: 29446
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases