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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 belowSelect...
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:Select...
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
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.
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.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,369 Total Patients Enrolled
Procter and GambleIndustry Sponsor
147 Previous Clinical Trials
76,683 Total Patients Enrolled
Tiffany Mayo, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped all skin treatments for eczema 2 weeks before my first visit.You have other serious health problems that are not being properly managed.I haven't taken any experimental drugs recently.You have skin conditions that make it hard for the doctor to understand any skin problems during the study.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.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.I haven't taken the study drug in the last 4 weeks.I have been on the same cancer treatment dose for the last 6 months.I am 18 years old or older.My skin condition affects 3-10% of my body.You have attempted suicide before or been hospitalized for a major mental illness in the last 3 years.I stopped all treatments for atopic dermatitis 4 weeks ago, or 6 months for biologics.I won't need systemic steroids, except for nasal or inhaled types, during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Bodewell Treatment
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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