EczemaCLeaNNCT01714245
A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
An observational study of Eczema and Atopic Dermatitis, run by TopMD Skin Care, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser formulated with surfactants and preserved with sodium hypochlorite, is effective at decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or eczema. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Eczema, Atopic Dermatitis
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with Atopic Dermatitis
Who may be able to join
- 6 months to 18 years
- moderate to severe Atopic Dermatitis
- positive staphylococcus aureus skin culture
Who cannot join
- active clinical infection
- on antibiotics in the last 4 weeks
- on immunosuppression drug in the last 4 weeks
- using bleach bath in the last 2 weeks
- able to maintain current regimen
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University, Department of Dermatology
Chicago, Illinois, 60611
University of Texas Medical School - Houston
Houston, Texas, 77030
About this study
Official title: A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis
The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser formulated with surfactants and preserved with sodium hypochlorite, is effective at decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or eczema.
Read the detailed description
Staphylococcus aureus colonization and potential infection represent a common clinical finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the disease. Atopic patients are commonly colonized with S. aureus on both lesional and non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the bacterial infection as well as reduce the overall severity of AD. More recently, measures to reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.
Given the increasing incidence of recurrent skin infections caused by S. aureus, measures such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an effort to decrease infection rates and disease severity in patients with atopic dermatitis, recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in patients without active clinical infection as one review noted limited benefit while another study showed that dilute bleach baths improved AD.
Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation, and is further diluted when lathered onto the skin with water. This over the counter product is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower, lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a convenient alternative to bleach baths.
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- Eczema, Atopic Dermatitis, Compromised Skin, Inflamed Skin
- Medical subject headings
- Eczema, Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Health of Skin EASI
Change from baseline in Eczema Area Severity Index (EASI) Score.
Measured: 6 weeks
Improvement in Health of Skin IGA
Change from baseline in Investigator Global Assessment (IGA) Score.
Measured: 6 weeks
Improvement in Health of Skin BSA
Change from baseline in Body Surface Area (BSA) Score.
Measured: 6 weeks
Secondary outcomes (3)
Patient satisfaction
Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.
Measured: 6 weeks
Decreased itching
Visual Analog Scale will be reviewed for decrease in pruritus.
Measured: 6 weeks
Reduction of bacteria
Bacterial cultures will be evaluated for decreased quantitative numbers.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TopMD Skin Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adelaide A. Hebert, MD, Principal investigator, University of Texas Medical School - Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714245
- Sponsor's protocol ID
- CLN 003.6
- Acronym
- CLeaN
- Status last verified
- Sep 2019
- First submitted
- 18 Oct 2012
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Majewski S, Bhattacharya T, Asztalos M, Bohaty B, Durham KC, West DP, Hebert AA, Paller AS. Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.
PubMed 30983053
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 Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01714245
- Acronym / sponsor ID
- CLeaN / CLN 003.6
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- Eczema, Atopic Dermatitis, Compromised Skin, Inflamed Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TopMD Skin Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Oct 2012 (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 determine if CLn BodyWash, a novel new gel cleanser formulated with surfactants and preserved with sodium hypochlorite, is effective at decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or eczema.
Detailed description
Staphylococcus aureus colonization and potential infection represent a common clinical finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the disease. Atopic patients are commonly colonized with S. aureus on both lesional and non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the bacterial infection as well as reduce the overall severity of AD. More recently, measures to reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.
Given the increasing incidence of recurrent skin infections caused by S. aureus, measures such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an effort to decrease infection rates and disease severity in patients with atopic dermatitis, recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in patients without active clinical infection as one review noted limited benefit while another study showed that dilute bleach baths improved AD.
Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation, and is further diluted when lathered onto the skin with water. This over the counter product is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower, lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a convenient alternative to bleach baths.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with Atopic Dermatitis
Key inclusion criteria (3 listed)
- 6 months to 18 years
- moderate to severe Atopic Dermatitis
- positive staphylococcus aureus skin culture
Key exclusion criteria (5 listed)
- active clinical infection
- on antibiotics in the last 4 weeks
- on immunosuppression drug in the last 4 weeks
- using bleach bath in the last 2 weeks
- able to maintain current regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in Health of Skin EASI
Time frame: 6 weeks
Change from baseline in Eczema Area Severity Index (EASI) Score.
Improvement in Health of Skin IGA
Time frame: 6 weeks
Change from baseline in Investigator Global Assessment (IGA) Score.
Improvement in Health of Skin BSA
Time frame: 6 weeks
Change from baseline in Body Surface Area (BSA) Score.
3 secondary outcomes
Patient satisfaction
Time frame: 6 weeks
Decreased itching
Time frame: 6 weeks
Reduction of bacteria
Time frame: 6 weeks
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 25 Sep 2019.
- Results publication: PubMed 30983053Majewski S, Bhattacharya T, Asztalos M, Bohaty B, Durham KC, West DP, Hebert AA, Paller AS. Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.
- Individual participant dataSharing planned: Undecided
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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.
Adelaide A. Hebert, MD principal investigator
University of Texas Medical School - Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eczema and Atopic Dermatitis, run by TopMD Skin Care, Inc. at 2 sites 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 3 inclusion and 5 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 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 2 sites 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?
Improvement in Health of Skin EASI (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714245, which also lists 1 linked publication.
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.