Using Bodewell products to treat atopic dermatitis

An Investigator Initiated Open-label Study Evaluating the Efficacy and Tolerability of Application of Bodewell Products for the Treatment of Atopic Dermatitis

This study tests if Bodewell Calming Cream can safely help adults with atopic dermatitis feel better by reducing their symptoms.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT05566262 on ClinicalTrials.gov

What this trial studies

This study examines the safety and effectiveness of the Bodewell Calming Cream for patients with chronic atopic dermatitis. Participants must be in good health, at least 18 years old, and have a diagnosis of atopic dermatitis affecting 3-10% of their body surface area. The study requires participants to discontinue other treatments for at least four weeks prior to the study. The goal is to assess how well this topical product can alleviate symptoms of atopic dermatitis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic atopic dermatitis affecting a significant portion of their skin.

Not a fit: Patients with uncontrolled significant co-morbid conditions or those currently using other treatments for atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing atopic dermatitis symptoms.

How similar studies have performed: While there have been studies on topical treatments for atopic dermatitis, the specific use of Bodewell products in this context is novel.

Eligibility criteria

Inclusion Criteria:

1. In good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co- morbid conditions).
2. 18 years of age or older
3. Able and willing to give written informed consent prior to any study procedures being conducted, and authorize the release and use of protected health information (PHI)
4. Willing to have photos taken of their skin
5. Diagnosis of chronic atopic dermatitis that has been present for at least 6 months prior to baseline
6. Atopic dermatitis involving at least 3-10 % of the patient's body surface area
7. Must have discontinued all systemic therapies for the treatment of atopic dermatitis at least 4 weeks or 5 half-lives, and biologics 6 months prior to baseline visit
8. Must have discontinued all topical therapies for the treatment of atopic dermatitis at least 2 weeks prior to baseline visit
9. Females of childbearing potential must use an approved birth control method while receiving treatment and for 28 days following the investigational product and there must be a documented negative pregnancy tests prior to initiating treatment. Approved birth control methods include hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation, partner vasectomy, or male or female condoms that are not made of natural materials PLUS a diaphragm with spermicide, cervical cap with spermicide, or a contraceptive sponge with spermicide.

   Females not of child bearing potential are defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy).
10. 5 patients must be on a stable dose of systemic therapy for the last 6 months prior to screening visit
11. 5 patients must be skin of color

Exclusion Criteria:

1. Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled
2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study
3. Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years
4. Pregnant or breast feeding
5. Active substance abuse or a history of substance abuse within 6 months prior to Screening
6. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
7. Prior treatment with the investigational product within 4 weeks prior to randomization
8. Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance)
9. Any other dermatologic conditions that prohibit or confound the ability of the investigator to interpret skin findings.
10. Patients who will be unable to avoid the use of systemic steroids, excluding intranasal or inhaled steroids that will be permitted, for the duration of the trial

Where this trial is running

Birmingham, Alabama

• The University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Tiffany Mayo, MD — University of Alabama at Birmingham
• Study coordinator: Ralee' B Bunt, MSPH

Conditions: Atopic Dermatitis