Assessing the Effect of Patient Characteristics on Treatment Response in Primary Hyperhidrosis
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 10/6/2018 |
| Start Date: | August 20, 2018 |
| End Date: | December 2020 |
| Contact: | Mitchell S Gibbons, BA |
| Email: | dermresearch@health.slu.edu |
| Phone: | 314-256-3435 |
A Prospective Study Assessing the Effect of Patient Characteristics on Treatment Response in Hyperhidrosis
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.
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.
Subject Recruitment
Recruitment will take place at SLUCare Dermatology Des Peres Clinic. Patients with non-study
related appointments with Dr. Glaser regarding the management of primary hyperhidrosis will
be approached by a research member. Patients will be given ample time to review study design
and have questions and concerns addressed. After inclusion and exclusion criteria, study
purpose and design, signed consent (parent or guardian will sign if subject is a minor),
assent (for minors only, not signed) and HIPAA release are attained, the patients will be
enrolled in the study.
The investigators will be recruiting two types of patients for this study. (1) New patients
being seen for evaluation for primary hyperhidrosis. These subjects will be presenting to the
hyperhidrosis clinic for the first time. If enrolled, these subjects will have all data
prospectively collected. (2) Established patients being seen for ongoing management of
primary hyperhidrosis who have documented baseline gravimetric measurements (defined as
measurements taken while the patient was undergoing no active therapies for primary
hyperhidrosis). These subjects will be presenting to the hyperhidrosis clinic for continued
care. If enrolled, these subjects will have some data collected retrospectively with the
remainder collected prospectively (see below for details).
Withdrawal or Discontinuation
Subjects may withdraw from the study at any time. If a subject desires withdraw from the
study, the subject will be give a reason for study withdraw which will be included in
publication. If a subject misses a scheduled visit the subject will be contacted via phone to
ask if the subject is withdrawing from the study or reschedule a visit.
Because the subjects are only undergoing gravimetry, a non invasive way of measuring sweat
production, it is highly unlikely that there would be any reason to discontinue a subjects
participation due to safety. However, if at any point the supervising provider feels that a
patient is at risk of harm the subject may be withdrawn from the study. In this case, a
reason would be recorded for publication purposes.
Screen Failures
For those that fail screening, all information collected prior to that time will be shredded
and disposed of in confidentiality trash bins. Only a reason for failing to pass screening
will be recorded for publication purposes.
Subject Visits
Subjects will be screened, sign consent (parent or guardian will sign if subject is a minor),
review assent (only applicable to minors) HIPAA release, and enrolled at an initial visit.
Patients will have a monthly electronic or telephone survey to fill out. Patients will be
seen every 3 months in clinic until the patient has achieved treatment response and/or no
treatment changes are required. 6 months after this visit, the patient will be seen in clinic
again***. If the subject has a sustained treatment response and/or has no treatment change,
the subject will exit the study. If these conditions are not met, then the subject will
resume 3 month visits.
It is important to note that these visit will overlap with non-study related visits that
occur as a part of management of the patient's disease. Disease management decisions, such as
which therapy to prescribe, will occur independently of this study and will not be affected
by study participation. All visits will occur within 18 months after the study begins. No
further study encounters will occur after this time period regardless of treatment changes or
response.
*** Subjects may choose to forgo this 6 months visit and complete it electronically or by
telephone.
New Patient
Subject Visit 1, 1 hour:
The subject will first verify his or her name and contact information. After the subject
agrees to study participation they will sign a consent (permission) and a release of health
information. Consent will be signed by parent or guardian if the subject is a minor. If the
subject is a minor assent will also be reviewed with the subject. Inclusion and exclusion
criteria will be reviewed.
Through an interview with a research team member and chart review, the following data will be
collected:
- Basic demographics
- Current treatments
- Hyperhidrosis Disease Severity Scale score (a scale that rates how the subject feels
sweating affects daily activities) for all sites:
- Scalp
- Face
- Underarms
- Inframammary
- Chest
- Back
- Hands
- Feet
- Groin
- Buttocks
- Questionnaire regarding the subject's disease state (see attachment).
Patients will then undergo gravimetric measurements of all sites affected by hyperhidrosis as
detailed in the attachment. Areas affected by HH will be defined by areas with an HDSS 3 or
greater. For details on the gravimetry protocol, see attachment.
Subject Visits, follow-up, 30 minutes:
The following data will be collected through subject interview:
- Current treatment
- HDSS for all sites.
- Questionnaire regarding the subject's disease state (see attachment).
- Presence or absence of side effects
Patients will then undergo gravimetric measurements for sites with previous measurements. For
detailed protocol see attachment.
Established Patient
Subject Visit 1, 1 hour:
The subject will first verify his or her name and contact information. After the subject
agrees to study participation they will sign a consent (permission) and a release of health
information. Consent will be signed by parent or guardian if the subject is a minor. If the
subject is a minor assent will also be reviewed with the subject. Inclusion and exclusion
criteria will be reviewed.
Through chart review, the following data will be collected:
- Baseline (defined as data collected while the patient was not undergoing any treatment)
HDSS score and gravimetric measurements for all sites
- Number of treatment changes since initiating care
- Basic demographics
Through an interview with the patient, the following information will be collected:
- Current treatment
- HDSS score for all sites
- Questionnaire regarding the subject's disease state (see attachment).
- Presence or absence side effects
Patients will then undergo gravimetric measurements for sites with previous gravimetric
measurements.
Subject Visit, follow-up 30 minutes:
This will be the same as new patient follow up visits.
Subject Electronic/Telephone Survey: Monthly, 15 minutes
The following data will be collected through a phone or electronic interview between a
research team member and the subject:
- Questionnaire regarding the subject's disease state (see attachment).
Recruitment will take place at SLUCare Dermatology Des Peres Clinic. Patients with non-study
related appointments with Dr. Glaser regarding the management of primary hyperhidrosis will
be approached by a research member. Patients will be given ample time to review study design
and have questions and concerns addressed. After inclusion and exclusion criteria, study
purpose and design, signed consent (parent or guardian will sign if subject is a minor),
assent (for minors only, not signed) and HIPAA release are attained, the patients will be
enrolled in the study.
The investigators will be recruiting two types of patients for this study. (1) New patients
being seen for evaluation for primary hyperhidrosis. These subjects will be presenting to the
hyperhidrosis clinic for the first time. If enrolled, these subjects will have all data
prospectively collected. (2) Established patients being seen for ongoing management of
primary hyperhidrosis who have documented baseline gravimetric measurements (defined as
measurements taken while the patient was undergoing no active therapies for primary
hyperhidrosis). These subjects will be presenting to the hyperhidrosis clinic for continued
care. If enrolled, these subjects will have some data collected retrospectively with the
remainder collected prospectively (see below for details).
Withdrawal or Discontinuation
Subjects may withdraw from the study at any time. If a subject desires withdraw from the
study, the subject will be give a reason for study withdraw which will be included in
publication. If a subject misses a scheduled visit the subject will be contacted via phone to
ask if the subject is withdrawing from the study or reschedule a visit.
Because the subjects are only undergoing gravimetry, a non invasive way of measuring sweat
production, it is highly unlikely that there would be any reason to discontinue a subjects
participation due to safety. However, if at any point the supervising provider feels that a
patient is at risk of harm the subject may be withdrawn from the study. In this case, a
reason would be recorded for publication purposes.
Screen Failures
For those that fail screening, all information collected prior to that time will be shredded
and disposed of in confidentiality trash bins. Only a reason for failing to pass screening
will be recorded for publication purposes.
Subject Visits
Subjects will be screened, sign consent (parent or guardian will sign if subject is a minor),
review assent (only applicable to minors) HIPAA release, and enrolled at an initial visit.
Patients will have a monthly electronic or telephone survey to fill out. Patients will be
seen every 3 months in clinic until the patient has achieved treatment response and/or no
treatment changes are required. 6 months after this visit, the patient will be seen in clinic
again***. If the subject has a sustained treatment response and/or has no treatment change,
the subject will exit the study. If these conditions are not met, then the subject will
resume 3 month visits.
It is important to note that these visit will overlap with non-study related visits that
occur as a part of management of the patient's disease. Disease management decisions, such as
which therapy to prescribe, will occur independently of this study and will not be affected
by study participation. All visits will occur within 18 months after the study begins. No
further study encounters will occur after this time period regardless of treatment changes or
response.
*** Subjects may choose to forgo this 6 months visit and complete it electronically or by
telephone.
New Patient
Subject Visit 1, 1 hour:
The subject will first verify his or her name and contact information. After the subject
agrees to study participation they will sign a consent (permission) and a release of health
information. Consent will be signed by parent or guardian if the subject is a minor. If the
subject is a minor assent will also be reviewed with the subject. Inclusion and exclusion
criteria will be reviewed.
Through an interview with a research team member and chart review, the following data will be
collected:
- Basic demographics
- Current treatments
- Hyperhidrosis Disease Severity Scale score (a scale that rates how the subject feels
sweating affects daily activities) for all sites:
- Scalp
- Face
- Underarms
- Inframammary
- Chest
- Back
- Hands
- Feet
- Groin
- Buttocks
- Questionnaire regarding the subject's disease state (see attachment).
Patients will then undergo gravimetric measurements of all sites affected by hyperhidrosis as
detailed in the attachment. Areas affected by HH will be defined by areas with an HDSS 3 or
greater. For details on the gravimetry protocol, see attachment.
Subject Visits, follow-up, 30 minutes:
The following data will be collected through subject interview:
- Current treatment
- HDSS for all sites.
- Questionnaire regarding the subject's disease state (see attachment).
- Presence or absence of side effects
Patients will then undergo gravimetric measurements for sites with previous measurements. For
detailed protocol see attachment.
Established Patient
Subject Visit 1, 1 hour:
The subject will first verify his or her name and contact information. After the subject
agrees to study participation they will sign a consent (permission) and a release of health
information. Consent will be signed by parent or guardian if the subject is a minor. If the
subject is a minor assent will also be reviewed with the subject. Inclusion and exclusion
criteria will be reviewed.
Through chart review, the following data will be collected:
- Baseline (defined as data collected while the patient was not undergoing any treatment)
HDSS score and gravimetric measurements for all sites
- Number of treatment changes since initiating care
- Basic demographics
Through an interview with the patient, the following information will be collected:
- Current treatment
- HDSS score for all sites
- Questionnaire regarding the subject's disease state (see attachment).
- Presence or absence side effects
Patients will then undergo gravimetric measurements for sites with previous gravimetric
measurements.
Subject Visit, follow-up 30 minutes:
This will be the same as new patient follow up visits.
Subject Electronic/Telephone Survey: Monthly, 15 minutes
The following data will be collected through a phone or electronic interview between a
research team member and the subject:
- Questionnaire regarding the subject's disease state (see attachment).
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.
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