Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Primary Purpose
Hyperhidrosis, Excess Sweating
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drysol
Drioff
Sponsored by
About this trial
This is an interventional prevention trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- age 21-30 years
- males and females
- The subjects are in good health.
- The subjects have willingness and the ability to understand and provide informed consent for participation in the study.
Exclusion Criteria:
- Subjects with primary hyperhidrosis
- Subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders.
- Subjects who are unable to give informed consent.
- Subjects with mental illness.
- Subjects who are pregnant or nursing.
- Subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.
Sites / Locations
- Northwestern University Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.
ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.
Outcomes
Primary Outcome Measures
Gravimetric analysis
Secondary Outcome Measures
Subject sweat assessment
HDSS
Full Information
NCT ID
NCT00509886
First Posted
July 31, 2007
Last Updated
November 7, 2014
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00509886
Brief Title
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Official Title
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.
Detailed Description
The objective of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Excess Sweating
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.
Arm Title
2
Arm Type
Experimental
Arm Description
ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.
Intervention Type
Drug
Intervention Name(s)
Drysol
Intervention Description
20% aluminum chloride hexahydrate
Intervention Type
Drug
Intervention Name(s)
Drioff
Intervention Description
1% aluminum acetate
Primary Outcome Measure Information:
Title
Gravimetric analysis
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Subject sweat assessment
Time Frame
3 hours
Title
HDSS
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 21-30 years
males and females
The subjects are in good health.
The subjects have willingness and the ability to understand and provide informed consent for participation in the study.
Exclusion Criteria:
Subjects with primary hyperhidrosis
Subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders.
Subjects who are unable to give informed consent.
Subjects with mental illness.
Subjects who are pregnant or nursing.
Subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis West, PhD
Organizational Affiliation
Northwestern University dermatology
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
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