Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DBI-001; Aqueous gel
Intervention description: Topical application of DBI-001 gel on skin affected with atopic dermatitis.; Topical application of aqueous gel on skin affected with atopic dermatitis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4
      weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Ability to understand, agree to, and sign the study Informed Consent. If the
             patient is unable to provide consent for him/herself, the patient's legally authorized
             representative may provide written consent.

          -  2. A signed Health Information Portability and Accountability Act (HIPAA)
             authorization form which permits the use and disclosure of subject's individually
             identifiable health information.

          -  3. Male or Female Subjects of any race 12 - 65 years of age.

          -  4. Physician diagnosed clinically stable AD according to the criteria of Hanifin and
             Rajka with symmetrical bilateral target lesions (Hanifin and Rajka 1980). Lesion on
             each arm or leg must have an Atopic Dermatitis Severity Index (ADSI) ≥6. The 2 sites
             need to be comparable anatomically symmetrical sites. It will be in the opinion of the
             Investigator based on subject's medical history whether the lesions are clinically
             stable.

          -  5. Female patients of child-bearing potential must use at least one method of birth
             control that results in a low failure rate (i.e., less than 1% per year) when used
             consistently and correctly such as implants, injectables, combined oral
             contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized
             partner for the duration of study participation.

          -  6. Technical ability and willingness to apply test articles during telemedicine visits
             with the study staff and unsupervised on weekends.

          -  7. Willingness to discontinue use of systemic AD treatments and topical treatments to
             the target areas for the duration of the study unless specifically permitted by the
             Investigator.

          -  8. Willingness to comply with test site restriction for 12 hours prior to all office
             visits including the Baseline visit and for 12 hours after each treatment application.
             These treatment site restrictions include:

               1. No washing of test sites with any cleansers or soaps at any time from the
                  Baseline visit to completion of the Day 42 Follow up Visit. Water passing over
                  the areas during showering is acceptable.

               2. No rubbing the test sites with a washcloth, towel, luffas. Pat dry after
                  showering is acceptable.

               3. No recreational activities in chlorinated or chemically treated water such as
                  swimming pools, hot tubs, and spas.

               4. No tight or form fitting clothing covering the treatment areas.

               5. No sunbathing or use of suntan parlors or tanning beds.

               6. If participating in physical activities resulting in heavy perspiration only pat
                  dry test site areas with towel if needed.

               7. Any activity that in the opinion of the investigator might alter the quality of
                  the samples collected or risk removal of the test article.

          -  9. Willingness to undergo the following washout periods:

               1. Washout of 2 weeks prior to the Baseline visit for topical treatments used on the
                  two treatment target sites, including but not limited to: antibacterial products,
                  anti-inflammatories (e.g., corticosteroids, tacrolimus, Pimecrolimus). Other than
                  the two sites on the arms or legs, topical medications may be used before/during
                  the duration of the study. Subjects will be provided 1% hydrocortisone for
                  treating non-target areas during the trial.

               2. Washout of 4 weeks prior to the Baseline visit for systemic treatments for AD,
                  including but not limited to corticosteroids (oral or intramuscular injections),
                  systemic immunomodulators or immunosuppressive (e.g., methotrexate, cyclosporine,
                  hydroxychloroquine), antibiotics (oral or injected, if required to treat a
                  medical condition short duration of oral antibiotics (≤10 days) are permitted
                  after randomization)

               3. Washout of 2 weeks prior to the Baseline visit for bleach baths.

               4. Washout of 2 weeks prior to the Baseline visit for phototherapy.

          -  10. No history of allergy to at least two of the following classes of antibiotics:
             Cephalosporin, Quinolone, Tetracycline, Aminoglycosides Macrolide, Carbapenems and
             Lipopeptides.

          -  11. Willingness to allow digital photos of arms or legs to be taken and stored.

        Exclusion Criteria:

          -  1. Women who are pregnant, planning a pregnancy, breastfeeding or have a positive
             pregnancy test at screening.

          -  2. Any dermatological conditions that could interfere with clinical evaluations or any
             disease state or physical condition which might expose the patient to an unacceptable
             risk by study participation.

          -  3. Any underlying disease(s) or other dermatological conditions that require the use
             of exclusionary topical or systemic therapy.

          -  4. Spontaneously improving or rapidly deteriorating dermatitis anywhere on the body.

          -  5. Netherton's syndrome or other genetic dermatoses that result in defective epidermal
             barrier function.

          -  6. Treatment of any type of cancer within the last 6 months other than cutaneous basal
             cell carcinoma.

          -  7. History of any significant internal disease (which contraindicates use of live
             microbiome e.g. leukemia, liver failure, cardiovascular disease).

          -  8. Subjects who are known to be allergic to any of the test product(s) or any
             components in the test product(s) or history of hypersensitivity or allergic reactions
             to any of the study preparations as described in the Investigator's Brochure.

          -  9. AIDS or AIDS related complex by medical history.

          -  10. Known or suspected immune suppressive medications or diseases or any condition
             that in the opinion of the investigator would increase the subject's susceptibility to
             opportunistic infections. 11. Treatment with systemic immune modulating or
             anti-inflammatory biologics agents within 16 weeks of Baseline Visit.

          -  12. Poorly controlled diabetes mellitus Type I or II by medical history.

          -  13. Peripheral vascular disease based on medical history.

          -  14. Any subject not able to meet the study attendance and telemedicine visit
             requirements.

          -  15. Participants with a history of psychiatric disease or history of alcohol or drug
             abuse that would interfere with the ability to comply with the study protocol.

          -  16. Subjects who have participated in any other trial of an investigational drug or
             device within 30 days prior to enrollment or participation in a research study
             concurrent with this study.