100 Participants Needed

Skin Cleanser for Eczema

PI
Overseen ByPrincipal Investigator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you should not have used systemic immunosuppressive drugs, phototherapy, biologics, topical steroids, or antibiotics within a specified time before starting the study. Check with the trial team for details on your specific medications.

Is the Skin Cleanser for Eczema safe for use in humans?

The Skin Cleanser for Eczema, also known as Skin Cleanser Combination No.1, has been evaluated in studies for its safety. One study found that a similar cream and cleanser combination was well tolerated with no adverse events reported, while another study highlighted that some cleansing creams can cause skin irritation and increased water loss, indicating the importance of choosing mild cleansers to minimize skin barrier damage.12345

What data supports the effectiveness of the treatment Skin Cleanser Combination No.1 for eczema?

Research shows that using skin care products with ceramides (important skin components) can improve eczema treatment by helping the skin barrier recover faster. This suggests that a cleanser with similar ingredients might also be effective in managing eczema.36789

Are You a Good Fit for This Trial?

This trial is for males and females aged 6 years or older who have been diagnosed with atopic dermatitis, a type of eczema. Participants must have a SCORAD (a measure of eczema severity) greater than 40 to join.

Inclusion Criteria

I am 6 years old or older.
SCORAD > 40
Meet atopic dermatitis Standard Diagnostic Criteria

Exclusion Criteria

Enrollment in another clinical trial
I do not have severe ongoing illnesses like heart or kidney disease.
Febrile illness at time of visits
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a three-week S. aureus decolonization regimen using Mupirocin, Chlorhexidine, and Sulfamethoxazole/trimethoprim

3 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of disease severity and additional cultures and biopsies

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Skin Cleanser Combination No.1
Trial Overview The study is testing whether using Skin Cleanser Combination No.1 can reduce the severity of atopic dermatitis by removing S. aureus bacteria from the skin and improving skin cell function.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Skin Cleansing RegimenExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Published Research Related to This Trial

A core outcome set (COS) for atopic eczema trials has been established, emphasizing the need for standardized outcomes such as clinical signs, quality of life, symptoms, and long-term flare control to improve comparability across studies.
The Eczema Area and Severity Index is recommended as the primary tool for assessing clinical signs in these trials, ensuring that all studies measure outcomes in a valid and reliable manner.
Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.Chalmers, J., Deckert, S., Schmitt, J.[2015]
Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.
After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.
New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis.de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

Citations

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema. [2015]
The effect of ceramide-containing skin care products on eczema resolution duration. [2013]
Role of mild cleansing in the management of patient skin. [2019]
Content validity of the Recap of atopic eczema (RECAP) instrument in Dutch, English and German to measure eczema control in young people with atopic eczema: a cognitive interview study. [2022]
Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. [2019]
Patient acceptability, efficacy, and skin biophysiology of a cream and cleanser containing lipid complex with shea butter extract versus a ceramide product for eczema. [2022]
Evaluation of mild skin cleansers. [2008]
New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]
Are adverse skin reactions to cosmetics underestimated in the clinical assessment of contact dermatitis? A prospective study among 1075 patients attending Swedish patch test clinics. [2019]
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