Non-prescription Versus Prescription Topical Treatments V... | NCT00509886

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

NCT00509886

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Nov 10, 2014Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Hyperhidrosis
Excess Sweating

Interventions

Drysol
Drioff

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jul 31, 2007

First Submission Date that Met QC Criteria

Jul 31, 2007

First Posted Date

Aug 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2014

Last Update Posted Date

Nov 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.	Drug: Drysol
2	Experimental	ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant.	Drug: Drioff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drysol	Drug	20% aluminum chloride hexahydrate	1
Drioff

Measure	Description	Time Frame
Gravimetric analysis		3 hours

Measure	Description	Time Frame
Subject sweat assessment		3 hours
HDSS		3 hours

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murad Alam, MD	Northwestern University dermatology	Principal Investigator
Dennis West, PhD	Northwestern University dermatology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Dermatology		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D006945	Hyperhidrosis

Ancestor Terms

ID	Term
D013543	Sweat Gland Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077410	Aluminum Chloride

Ancestor Terms

ID	Term
D017607	Aluminum Compounds
D007287	Inorganic Chemicals
D002712	Chlorides
D006851	Hydrochloric Acid

Browse Leaves

Not provided

Browse Branches

Not provided