Atopic DermatitisPhase 4NCT05566262
Bodewell Products for the Treatment of Atopic Dermatitis
A Phase 4 study testing Bodewell Calming Cream in people with Atopic Dermatitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Bodewell Calming Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 18 years of age or older
- 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)
- Willing to have photos taken of their skin
- Diagnosis of chronic atopic dermatitis that has been present for at least 6 months prior to baseline
- Atopic dermatitis involving at least 3-10 % of the patient's body surface area
Show all 12Show fewer
- 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
- Must have discontinued all topical therapies for the treatment of atopic dermatitis at least 2 weeks prior to baseline visit
- 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).
- 5 patients must be on a stable dose of systemic therapy for the last 6 months prior to screening visit
- 5 patients must be skin of color
Who cannot join
- 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
- 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
- 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
- Pregnant or breast feeding
- Active substance abuse or a history of substance abuse within 6 months prior to Screening
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
Show all 10Show fewer
- Prior treatment with the investigational product within 4 weeks prior to randomization
- Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance)
- Any other dermatologic conditions that prohibit or confound the ability of the investigator to interpret skin findings.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: An Investigator Initiated Open-label Study Evaluating the Efficacy and Tolerability of Application of Bodewell Products for the Treatment of Atopic Dermatitis
This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products
- Conditions
- Atopic Dermatitis
- Being tested
- Bodewell Calming Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodewell Calming CreamDrug
Bodewell is a non-prescription and contains 22 botanical ingredients in addition to colloidal oatmeal.
| Study group | Role | What they receive |
|---|---|---|
| Bodewell Treatment | Experimental | All patients will be treated with the active product, Bodewell. Bodewell will be applied topically twice a day to all active lesions. Receives: Drug: Bodewell Calming Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage improvement in Patient Global Assessment (PGA)
Mean percentage improvement in the Patient Global Assessment from baseline to week 12. This assessment is a scale from 0 to 4. 0 means clear skin while 4 means severe disease.
Measured: Baseline to week 12
Secondary outcomes (1)
Percent improvement in Dermatology Life Quality Index (DLQI)
Percent improvement in Dermatology Life Quality Index (DLQI) from baseline to week 12. The DLQI consists of 10 questions, with each question being on a scale of 0 (clear) to 3 (more severe). The overall scoring scale is from 0 to 30. A higher score means a more severe outcome.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Nov 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, Tiffany Mayo, MD, University of Alabama at Birmingham
- Investigators
- Tiffany Mayo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566262
- Sponsor's protocol ID
- IRB-300008755
- Other IDs
- UAB
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Open-label Study Evaluating the Efficacy and Tolerability of Application of Bodewell Products for the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05566262
- Acronym / sponsor ID
- IRB-300008755
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bodewell Treatment | Experimental | Drug: Bodewell Calming CreamAll patients will be treated with the active product, Bodewell. Bodewell will be applied topically twice a day to all active lesions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
- 18 years of age or older
- 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)
- Willing to have photos taken of their skin
- Diagnosis of chronic atopic dermatitis that has been present for at least 6 months prior to baseline
Key exclusion criteria (10 listed)
- 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
- 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
- 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
- Pregnant or breast feeding
- Active substance abuse or a history of substance abuse within 6 months prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodewell Calming CreamBodewell is a non-prescription and contains 22 botanical ingredients in addition to colloidal oatmeal. | Drug | Bodewell Treatment |
Primary outcome
Mean Percentage improvement in Patient Global Assessment (PGA)
Time frame: Baseline to week 12
Mean percentage improvement in the Patient Global Assessment from baseline to week 12. This assessment is a scale from 0 to 4. 0 means clear skin while 4 means severe disease.
1 secondary outcome
Percent improvement in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Mayo, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bodewell Calming Cream in people with Atopic Dermatitis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percentage improvement in Patient Global Assessment (PGA) (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.