EczemaNCT01826630
A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema
A study testing CLn BodyWash and Cetaphil Daily Facial Cleanser in people with Eczema and Hand Eczema, run by Shari L Hand at 1 site in United States.
Trial summary
The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema, Hand Eczema, Atopic Dermatitis
- What is being tested?
- CLn BodyWash and Cetaphil Daily Facial Cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
- Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
- Willingness to participate in a research study.
- Diagnosis of chronic hand dermatitis
Who cannot join
- Inability to provide informed consent
- Allergy to any of the treatments used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.
The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.
Read the detailed description
Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.
- Conditions
- Eczema, Hand Eczema, Atopic Dermatitis
- Being tested
- CLn BodyWash, Cetaphil Daily Facial Cleanser
- Keywords
- CLn Body Wash, CLn BodyWash
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLn BodyWashOther
Comparing two washes to determine change in bacterial load.
Cetaphil Daily Facial CleanserOther
Also called Cetaphil Daily Facial
Comparing two washes to determine change in bacterial load.
| Study group | Role | What they receive |
|---|---|---|
| CLn BodyWash | Active comparator | CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis Receives: Other: CLn BodyWash |
| Cetaphil Daily Facial Cleanser | Active comparator | Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis Receives: Other: Cetaphil Daily Facial Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amount of Skin Fauna
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
Measured: one wash
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shari L Hand
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TopMD Skin Care, Inc.
- Responsible party
- Sponsor-investigator, Shari L Hand, TopMD Skin Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826630
- Sponsor's protocol ID
- CLN 2012H0327
- Status last verified
- Nov 2014
- First submitted
- 20 Feb 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT01826630
- Acronym / sponsor ID
- CLN 2012H0327
- Conditions
- Eczema, Hand Eczema, Atopic Dermatitis
- Keywords
- CLn Body Wash, CLn BodyWash
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Shari L HandIndustry (pharma, biotech, devices)
- Collaborators
- TopMD Skin Care, Inc.
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Apr 2013 (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 primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.
Detailed description
Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLn BodyWash | Active comparator | Other: CLn BodyWashCLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis |
| Cetaphil Daily Facial Cleanser | Active comparator | Other: Cetaphil Daily Facial CleanserCetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
- Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
- Willingness to participate in a research study.
- Diagnosis of chronic hand dermatitis
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Allergy to any of the treatments used
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 |
|---|---|---|
| CLn BodyWashComparing two washes to determine change in bacterial load. | Other | CLn BodyWash |
| Cetaphil Daily Facial CleanserAlso: Cetaphil Daily FacialComparing two washes to determine change in bacterial load. | Other | Cetaphil Daily Facial Cleanser |
Primary outcome
Change in Amount of Skin Fauna
Time frame: one wash
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
Results and safety
The study was stopped early (reason given: Difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLn BodyWash and Cetaphil Daily Facial Cleanser in people with Eczema and Hand Eczema, run by Shari L Hand 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 2 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: stopped early, as of the sponsor's last update on 25 Sep 2019. 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 was stopped early (reason given: Difficulty enrolling patients). Results are not available in the source record.
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?
Change in Amount of Skin Fauna (time frame: one wash). 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 25 Sep 2019.