Bodewell Calming Cream for Eczema

Overseen By Ralee' B Bunt, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Systemic therapies, Biologics

Disqualifiers: Uncontrolled major disease, Pregnancy, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking all systemic and topical therapies for atopic dermatitis before joining the trial. Systemic therapies must be stopped at least 4 weeks or 5 half-lives before the baseline visit, and biologics 6 months prior. Topical therapies must be stopped at least 2 weeks before the baseline visit.

What data supports the effectiveness of the Bodewell Calming Cream treatment for eczema?

While there is no direct data on Bodewell Calming Cream, studies on similar treatments like pimecrolimus cream show effectiveness in controlling eczema and improving quality of life for patients and their families. Additionally, clobetasol propionate has been shown to be effective in treating eczema, suggesting that similar topical treatments can be beneficial. ^{1 2 3 4 5}

How is Bodewell Calming Cream different from other eczema treatments?

Bodewell Calming Cream is unique because it is a steroid-free, over-the-counter option for eczema, which may reduce the risk of side effects like skin thinning associated with steroid creams. This makes it a safer choice for long-term use, especially on sensitive areas like the face. ^{2 4 6 7 8}

Research Team

Tiffany Mayo

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

I stopped all skin treatments for eczema 2 weeks before my first visit.

I am using effective birth control and have a negative pregnancy test.

I have been diagnosed with chronic atopic dermatitis for at least 6 months.

Exclusion Criteria

Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance)

You have other serious health problems that are not being properly managed.

I haven't taken any experimental drugs recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Bodewell product applied topically twice a day to all active lesions

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bodewell Calming Cream

Trial Overview 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.

Participant Groups

Group I: Bodewell Treatment Experimental Treatment 1 Intervention

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

Bodewell Calming Cream is already approved in United States for the following indications:

Approved in United States as Bodewell for:

• Atopic Dermatitis (Eczema)
• Psoriasis

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Procter and Gamble

Industry Sponsor

Trials

150

Recruited

77,000+

Marc Pritchard

Procter and Gamble

Chief Marketing Officer since 2008

B.S. in Finance from Indiana University, Bloomington

Jon R. Moeller

Procter and Gamble

Chief Executive Officer since 2021

MBA from Cornell University, B.S. in Biology from Cornell University

Findings from Research

Chronic hand/foot eczema treatment is complex and requires a comprehensive approach that includes identifying irritants, patch testing, and discussing individual treatment goals with patients, focusing on restoring function as the primary aim.

For moderately symptomatic patients, starting with potent topical corticosteroids is recommended, and if ineffective, options like phototherapy or systemic treatments such as methotrexate or ciclosporin can be considered, while severe cases may require short-term systemic corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic hand and foot eczema. An Australia/New Zealand Clinical narrative. Rademaker, M., Armour, K., Baker, C., et al.[2021]

In a study of 227 patients with psoriasis and eczema, clobetasol propionate cream was found to be significantly more effective than fluocinonide cream in improving symptoms and healing rates, particularly in psoriasis.

Both treatments were generally safe, but clobetasol had fewer side effects (4% of patients) compared to fluocinonide (12% of patients), and any transient cortisol reductions in clobetasol-treated patients returned to normal within a week after stopping treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clobetasol propionate versus fluocinonide creams in psoriasis and eczema. Jegasothy, B., Jacobson, C., Levine, N., et al.[2019]

In a study of 196 infants with atopic eczema, treatment with pimecrolimus cream 1% for 4 weeks resulted in a significant improvement in eczema severity, with a 71.5% reduction compared to only 19.4% with the vehicle cream.

The use of pimecrolimus also positively impacted parents' quality of life across multiple domains, including emotional coping and psychosomatic well-being, indicating that effective treatment of eczema can enhance the overall well-being of families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial. Staab, D., Kaufmann, R., Bräutigam, M., et al.[2014]

In a study involving 2034 patients with mild to moderate atopic eczema, pimecrolimus cream 1% applied twice daily led to treatment success in 59% of patients after 3 months, with 81% achieving clear or almost clear skin on the face.

Pimecrolimus cream demonstrated a favorable safety profile, with 79% of patients experiencing absent or mild itching, making it a suitable long-term treatment option for delicate areas like the face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. Ring, J., Abraham, A., de Cuyper, C., et al.[2022]

In a 52-week study involving 869 patients with moderate-to-severe scalp psoriasis, a two-compound formulation of calcipotriol and betamethasone dipropionate showed significantly fewer adverse drug reactions (17.2%) compared to calcipotriol alone (29.5%).

The two-compound formulation effectively controlled the disease in 92.3% of visits, compared to 80.0% for calcipotriol, indicating its superior efficacy for long-term management of scalp psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis. Luger, TA., Cambazard, F., Larsen, FG., et al.[2022]

Eucerin Eczema Relief Body Crème and Instant Therapy cream were tested in children aged 3 months to 12 years, showing significant improvements in skin hydration and reduction of atopic dermatitis symptoms, including itching and redness.

Both products were found to be safe and well tolerated, providing effective steroid-free options for managing atopic dermatitis in infants and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis. Weber, TM., Herndon, JH., Ewer, M., et al.[2020]

A study involving 149 patients with atopic dermatitis and 194 with psoriasis found that a once daily application of 0.1% halcinonide cream is effective and can be recommended for certain patients, such as young children or pregnant women.

However, the three times daily regimen of halcinonide cream was found to be superior overall, making it the preferred treatment option, especially for severe psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of single and multiple applications of halcinonide cream. Sudilovsky, A., Muir, JG., Bocobo, FC.[2019]

In a study of 97 out-patients with steroid-responsive skin conditions (63 with eczema and 34 with psoriasis), both once-daily and twice-daily applications of betamethasone dipropionate cream were found to be equally effective over a 3-week treatment period.

However, eczema patients using the cream twice daily experienced quicker symptomatic relief, indicating that while both regimens are effective, more frequent application may provide faster results for certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind comparison of the efficacy of betamethasone dipropionate cream twice daily versus once daily in the treatment of steroid responsive dermatoses. English, JS., Bunker, CB., Ruthven, K., et al.[2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Management of chronic hand and foot eczema. An Australia/New Zealand Clinical narrative. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Clobetasol propionate versus fluocinonide creams in psoriasis and eczema. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial. [2014]

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

Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis. [2022]

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

Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A comparison of single and multiple applications of halcinonide cream. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A double-blind comparison of the efficacy of betamethasone dipropionate cream twice daily versus once daily in the treatment of steroid responsive dermatoses. [2019]