Skin Cleanser for Eczema

Overseen By Principal Investigator

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Children's Hospital

Must not be taking: Immunosuppressives, Biologics, Topical steroids, Antibiotics

Disqualifiers: HIV, Hepatitis, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

100 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Skin Cleansing Regimen Experimental Treatment 1 Intervention

1. Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily 2. Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed. 3. Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of ceramide-containing skin care products on eczema resolution duration. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Role of mild cleansing in the management of patient skin. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. China pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of mild skin cleansers. [2008]

8. Switzerland pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]

9. Sweden pubmed.ncbi.nlm.nih.gov

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]