15 Participants Needed

Bodewell Calming Cream for Eczema

CL
RB
Overseen ByRalee' B Bunt, MSPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
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
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.15678

Who Is on the Research Team?

TM

Tiffany Mayo

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.
See 8 more

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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Bodewell TreatmentExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Bodewell for:

Find a Clinic Near You

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 profile image

Marc Pritchard

Procter and Gamble

Chief Marketing Officer since 2008

B.S. in Finance from Indiana University, Bloomington

Jon R. Moeller profile image

Jon R. Moeller

Procter and Gamble

Chief Executive Officer since 2021

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

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Management of chronic hand and foot eczema. An Australia/New Zealand Clinical narrative. [2021]
Clobetasol propionate versus fluocinonide creams in psoriasis and eczema. [2019]
Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial. [2014]
Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. [2022]
A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis. [2022]
Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis. [2020]
A comparison of single and multiple applications of halcinonide cream. [2019]
A double-blind comparison of the efficacy of betamethasone dipropionate cream twice daily versus once daily in the treatment of steroid responsive dermatoses. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security