RECRUITING

Bodewell Products for the Treatment of Atopic Dermatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products

Official Title

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

Quick Facts

Study Start:2023-11-01

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05566262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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	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

Inclusion Criteria

Exclusion 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.
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

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

Contacts and Locations

Study Contact

Ralee' B Bunt, MSPH

CONTACT

205-502-9960

erikabunt@uabmc.edu

Principal Investigator

Tiffany Mayo, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Tiffany Mayo, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis