New ointment shows promise for eczema sufferers
NCT ID NCT06810050
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new ointment called CGB-500, which contains the drug tofacitinib, for treating eczema (atopic dermatitis) in 180 people aged 12 and older. Participants applied the ointment or a placebo daily for 8 weeks. The goal was to see if it safely reduces skin redness, itching, and rash. Results will show whether this ointment could become a new treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CGB-500 ointment with tofacitinib (a drug that calms the immune system)
- What this could lead to
- If it works, this could offer a new topical treatment option for eczema that reduces skin redness, itching, and rash.
- What could go wrong
- This is a Phase 2 trial with only 180 people, so results may not apply to everyone. Tofacitinib can have side effects like skin irritation or infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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180 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of childbearing potential (FOBCP) must have a negative urine pregnancy test at Screening and Baseline and practice a reliable method of contraception throughout the trial. 2. Have a clinical diagnosis of atopic dermatitis (AD) for at least 12 months prior to Baseline that has been clinically stable disease for ≥ 3 months at the time of the screening visit and prior to dose administration and is confirmed to be AD according to the criteria of Hanifin and Rajka. 3. Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline. 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 at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the scalp, genitalia, palms, or soles. 6. In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion). 7. Have peak pruritus numeric rating scale (PPNRS) score of ≥ 4 on the scale 0 to 10 at Screening 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, which includes 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 if of 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) at the Screening visit that, in the opinion of the investigator, would preclude participation in the study or affect proper assessment of the study endpoints 5. Skin infections (e.g., bacterial, fungal or viral) that can interfere with reliable AD assessments. 6. Basal cell carcinoma within 6 months prior to Baseline. 7. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, uncontrolled diabetes, malignancy, or serious active or recurrent infection. 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 filtration rate (eGFR) \<60 mL/min using Cockcroft-Gault (C-G) equation (eGFR between 60 to \<90 mL/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 weeks prior 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 for atopic dermatitis (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib). 12. Participants who had an adequate response to JAK inhibitors will be excluded if the following are met: 1. Use within 2 weeks prior to Baseline of topical JAK inhibitors. 2. Use within 4 weeks prior to Baseline of systemic JAK inhibitors. 13. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids. 14. Use within 7 days on the treatment area(s) prior to Baseline of: 1) topical antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products. 15. Use of the following treatments prior to Baseline: 1. For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g., dupilumab). 2. For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus). 3. For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy, tanning booths, or non-prescription UV light sources. 4. For 2 weeks - immunizations and sedating antihistamines unless on long-term stable regimen (nonsedating antihistamines are permitted). 5. For 2 weeks - use of other topical treatments for atopic dermatitis (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed if they do not exceed 2 baths per week and their frequency remains the same throughout the trial. 16. Uncontrolled systemic disease. 17. Any serious illness or condition(s) that, in the opinion of the PI, would interfere with full participation in the trial, including administration of IP and attending required trial visits; pose a significant risk to the participant; or interfere with interpretation of trial data. 18. Foreseen unprotected and intense/excessive UV exposure during the trial. 19. Scheduled or planned surgical procedures during the trial. 20. Unable or unwilling to comply with any of the trial requirements. 21. Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with trial participation or may interfere with interpretation of trial results or participant compliance and, in the opinion of the PI, makes the participant inappropriate for trial entry. 22. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 23. Employees of the research center or Investigator. 24. Family of members of employees of the research center or Investigator. 25. Participants (e.g. siblings, spouses, relatives, roommates) residing in the same household cannot be enrolled at the same time. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266, United States
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Center for Dermatology Clinical Research Inc.
Fremont, California, 94538, United States
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Cordova Research Institute
Sweetwater, Florida, 33182, United States
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DermResearch
Austin, Texas, 78759, United States
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Driven Research
Gables, Florida, 33134, United States
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FXM Clinical Research
Fort Lauderdale, Florida, 33308, United States
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FXM Clinical Research Miami, LLC
Miami, Florida, 33175, United States
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FXM Clinical Research Miramar, LLC
Miramar, Florida, 33027, United States
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J&S Studies, Inc.
New Brighton, Minnesota, 55112, United States
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JDR Dermatology Research
Las Vegas, Nevada, 89148, United States
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Metro Boston Clinical Partners
Brighton, Massachusetts, 02135, United States
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Syrentis Clinical Research
Santa Ana, California, 92705, United States
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TCR Medical Corporation
San Diego, California, 92123, United States
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Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
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The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
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USA and International Research Inc.
Doral, Florida, 33126, United States
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