Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all of the following criteria:

1. Outpatient, male or female of any race, 12 years of age or older. Females ofchildbearing potential (FOBCP) must have a negative urine pregnancy test atScreening and Baseline and practice a reliable method of contraception throughoutthe trial.

2. Have a clinical diagnosis of atopic dermatitis (AD) for at least 12 months prior toBaseline that has been clinically stable disease for ≥ 3 months at the time of thescreening visit and prior to dose administration and is confirmed to be AD accordingto the criteria of Hanifin and Rajka.

3. Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening andBaseline.

4. Have AD lesions/symptoms covering at least 1% but less than 10% of total BSA (excluding scalp, genitalia, palms, and soles) at Screening and Baseline.

5. Have at least 1 "target lesion" that measures approximately 10 cm2 or more atScreening and Baseline. Lesion must be representative of the participant's diseasestate and not be located on the scalp, genitalia, palms, or soles.

6. In general, good health as determined by medical history and physical examination atthe time of screening (investigator discretion).

7. Have peak pruritus numeric rating scale (PPNRS) score of ≥ 4 on the scale 0 to 10 atScreening and Baseline.

8. Be able to follow trial instructions and likely to complete all required visits.

9. Sign the institutional review board (IRB)-approved informed consent form (ICF, whichincludes HIPAA) and assent prior to any trial-related procedures being performed.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this trial:

1. Females who are pregnant, breastfeeding, intending to be pregnant during the trial,or who do not agree to use an acceptable form of birth control during the trial ifof childbearing potential .

2. Immunocompromised individuals as adjudicated by the principal investigator (PI)based on review of medical history.

3. Known hypersensitivity or previous allergic reaction to any constituent of the IP (e.g., tofacitinib or Janus kinase (JAK) inhibitors, essential oils, choline,phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).

4. Has clinically significant safety labs (hematology, chemistry, and urinalysis) atthe Screening visit that, in the opinion of the investigator, would precludeparticipation in the study or affect proper assessment of the study endpoints

5. Skin infections (e.g., bacterial, fungal or viral) that can interfere with reliableAD assessments.

6. Basal cell carcinoma within 6 months prior to Baseline.

7. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, orichthyosis or presence of Netherton's Syndrome, immunological deficiencies ordiseases, HIV, uncontrolled diabetes, malignancy, or serious active or recurrentinfection.

8. Known hepatic impairment or disorder and/or ALT and AST >3X ULN at Screening.

9. Has unstable and impaired renal function with an estimated glomerular filtrationrate (eGFR) <60 mL/min using Cockcroft-Gault (C-G) equation (eGFR between 60 to <90mL/minute or higher is acceptable).

10. Use of moderate to strong CYP3A4 and CYP3A5 inhibitors (e.g. ritonavir,clarithromycin, itraconazole, erythromycin, fluconazole, verapamil, ketoconazole,nefazodone, nelfinavir, diltiazem, ciprofloxacin, grapefruit juice) within 4 weeksprior to Baseline.

11. Participants who have previously failed or had an inadequate response to oral,systemic or topical JAK inhibitors, including in a trial or under a prescription foratopic dermatitis (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib,lestaurtinib, pacritinib).

12. Participants who had an adequate response to JAK inhibitors will be excluded if thefollowing are met:

13. Use within 2 weeks prior to Baseline of topical JAK inhibitors.

14. Use within 4 weeks prior to Baseline of systemic JAK inhibitors.

15. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotrieneor 3) retinoids.

16. Use within 7 days on the treatment area(s) prior to Baseline of: 1) topicalantihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) othertopical drug products.

17. Use of the following treatments prior to Baseline:

18. For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g.,dupilumab).

19. For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs,cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive orimmunomodulating agents (e.g., mycophenolate or tacrolimus).

20. For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy,tanning booths, or non-prescription UV light sources.

21. For 2 weeks - immunizations and sedating antihistamines unless on long-termstable regimen (nonsedating antihistamines are permitted).

22. For 2 weeks - use of other topical treatments for atopic dermatitis (other thanbland emollients). Diluted sodium hypochlorite "bleach" baths are allowed ifthey do not exceed 2 baths per week and their frequency remains the samethroughout the trial.

23. Uncontrolled systemic disease.

24. Any serious illness or condition(s) that, in the opinion of the PI, would interferewith full participation in the trial, including administration of IP and attendingrequired trial visits; pose a significant risk to the participant; or interfere withinterpretation of trial data.

25. Foreseen unprotected and intense/excessive UV exposure during the trial.

26. Scheduled or planned surgical procedures during the trial.

27. Unable or unwilling to comply with any of the trial requirements.

28. Medical or psychiatric conditions, or a personal situation, that may increase therisk associated with trial participation or may interfere with interpretation oftrial results or participant compliance and, in the opinion of the PI, makes theparticipant inappropriate for trial entry.

29. Clinically significant alcohol or drug abuse, or history of poor cooperation orunreliability.

30. Employees of the research center or Investigator.

31. Family of members of employees of the research center or Investigator.

32. Participants (e.g. siblings, spouses, relatives, roommates) residing in the samehousehold cannot be enrolled at the same time.