What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, such as topical corticosteroids and moisturizers, generally have a favorable safety profile but can have side effects. Topical corticosteroids may cause skin thinning, stretch marks, and systemic absorption leading to hormonal imbalances if used excessively. Moisturizers, while generally safe, can sometimes lead to skin irritation or allergic reactions. Colloidal oatmeal creams, like the 1% formulation studied, are typically well-tolerated with minimal side effects, primarily limited to mild skin irritation in some cases.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that focus on anti-inflammatory and moisturizing effects. Notable examples include topical corticosteroids, which are commonly used for their anti-inflammatory properties, and topical calcineurin inhibitors like tacrolimus and pimecrolimus, which reduce inflammation without the side effects associated with steroids. Additionally, crisaborole ointment, a non-steroidal anti-inflammatory drug, has been approved for mild-to-moderate atopic dermatitis. Dupilumab, a biologic agent, has also been approved for moderate-to-severe cases, offering an anti-inflammatory effect by targeting specific immune pathways. These treatments aim to manage symptoms and improve skin barrier function, similar to the goals of Bodewell Eczema Products.

What other types of research exist?

Promising novel alternatives to Bodewell Eczema Products for atopic dermatitis include: 1) Crisaborole topical ointment, a phosphodiesterase-4 inhibitor, which has shown significant antipruritic activity in clinical studies. 2) MD2011001 cream, a nonsteroidal topical cream containing vitamin E, epigallocatechin gallate, and grape seed procyanidins, which has demonstrated efficacy in reducing symptoms of mild-to-moderate atopic dermatitis. 3) Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, which has been effective in treating moderate-to-severe atopic dermatitis in both children and adults. These treatments offer anti-inflammatory and moisturizing effects, making them viable alternatives for patients.

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Moisturizer

Bodewell Calming Cream for Eczema

Phase 4

Recruiting

Led By Tiffany Mayo, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females not of childbearing potential are defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy)

5 patients must be on a stable dose of systemic therapy for the last 6 months prior to screening visit

Must not have

Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)

Prior treatment with the investigational product within 4 weeks prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Bodewell creams or lotions on people with eczema. The products are applied to the skin to help reduce itching and inflammation.

Who is the study for?

Adults with chronic atopic dermatitis covering 3-10% of their body, who've had the condition for at least 6 months. Participants must be in good health aside from eczema, not using topical or systemic eczema treatments for a set period before the trial, and women must use birth control if applicable. Excludes those with substance abuse history, significant psychiatric issues, or other major uncontrolled diseases.

What is being tested?

The study is testing Bodewell Calming Cream's safety and effectiveness when applied to the skin of adults with atopic dermatitis (eczema). The cream's impact on skin symptoms will be monitored through physical examinations and photographs.

What are the potential side effects?

While specific side effects are not listed here, typical reactions to topical creams may include skin irritation, redness, itching or burning sensation where the product is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who cannot become pregnant because I am either postmenopausal for at least 1 year or have had surgery to prevent pregnancy.

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I have been on the same cancer treatment dose for the last 6 months.

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I am 18 years old or older.

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My skin condition affects 3-10% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs recently.

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I haven't taken the study drug in the last 4 weeks.

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I won't need systemic steroids, except for nasal or inhaled types, during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Percentage improvement in Patient Global Assessment (PGA)

Secondary study objectives

Percent improvement in Dermatology Life Quality Index (DLQI)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bodewell TreatmentExperimental Treatment1 Intervention

All patients will be treated with the active product, Bodewell. Bodewell will be applied topically twice a day to all active lesions.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and emollients. Topical corticosteroids reduce inflammation by suppressing the immune response, which helps to alleviate redness, swelling, and itching. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, also reduce inflammation by inhibiting T-cell activation, which is crucial in the inflammatory process of AD. Emollients and moisturizers work by restoring the skin barrier, preventing water loss, and protecting the skin from irritants and allergens. These treatments are essential for AD patients as they address both the inflammatory and barrier dysfunction components of the disease, leading to improved skin condition and reduced symptoms.