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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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperhidrosis

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 31, 2007
Last Updated
November 7, 2014
Sponsor
Northwestern University
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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

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Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating

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