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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
Study Summary
This trial looks at how well and safely the Bodewell eczema products work when applied to the skin.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Percentage improvement in Patient Global Assessment (PGA)
Secondary outcome measures
Percent improvement in Dermatology Life Quality Index (DLQI)
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,297 Total Patients Enrolled
Procter and GambleIndustry Sponsor
146 Previous Clinical Trials
76,565 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study seeking elderly participants?
"In order to satisfy the requirements of this trial, participants must be between 18 and 99 years old. Separately 101 studies are enrolling minors and 165 for seniors."
Answered by AI
Has the Bodewell Treatment been approved by the Food and Drug Administration's standards?
"Bodewell Treatment is officially sanctioned for clinical use, thus receiving a 3 on the safety scale. This treatment has cleared Phase 4 of its medical trial process."
Answered by AI
Is eligibility for this clinical experiment open to me?
"Entrants to this medical trial must suffer from dermatitis and be within the age bracket of 18-99. Fifteen patients are being accepted for enrolment in total."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
How long is this study?
PatientReceived no prior treatments
Why did patients apply to this trial?
I am looking for a product that treats my.condition.
PatientReceived 2+ prior treatments
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