Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
Not provided
Not provided
Not provided
This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bodewell Calming Cream | Drug | Bodewell is a non-prescription and contains 22 botanical ingredients in addition to colloidal oatmeal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 12 |
Not provided
Inclusion Criteria:
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
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tiffany Mayo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |