HyperhidrosisNCT00509886
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
A study testing Drysol and Drioff in people with Hyperhidrosis and Excess Sweating, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis, Excess Sweating
- What is being tested?
- Drysol and Drioff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Dermatology
Chicago, Illinois, 60611
About this study
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.
Read the 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.
- Conditions
- Hyperhidrosis, Excess Sweating
- Being tested
- Drysol, Drioff
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrysolDrug
20% aluminum chloride hexahydrate
DrioffDrug
1% aluminum acetate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant. Receives: 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. Receives: Drug: Drioff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gravimetric analysis
Measured: 3 hours
Secondary outcomes (2)
Subject sweat assessment
Measured: 3 hours
HDSS
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University dermatologyDennis West, PhD, Study director, Northwestern University dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509886
- Sponsor's protocol ID
- STU00000722
- Status last verified
- Nov 2014
- First submitted
- 31 Jul 2007
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
- ClinicalTrials.gov ID
- NCT00509886
- Acronym / sponsor ID
- STU00000722
- Conditions
- Hyperhidrosis, Excess Sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DrysolARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant. |
| 2 | Experimental | Drug: DrioffARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drysol20% aluminum chloride hexahydrate | Drug | 1 |
| Drioff1% aluminum acetate | Drug | 2 |
Primary outcome
Gravimetric analysis
Time frame: 3 hours
2 secondary outcomes
Subject sweat assessment
Time frame: 3 hours
HDSS
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University dermatology
Dennis West, PhD study director
Northwestern University dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drysol and Drioff in people with Hyperhidrosis and Excess Sweating, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gravimetric analysis (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.