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The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGB-500 topical ointment, 1% tofacitinib | Experimental |
| |
| Vehicle topical ointment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib Citrate | Drug | Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Frequency of subjects with Treatment-Emergent Adverse Events (TEAEs). • Frequency of subjects with skin irritation TEAEs and any other adverse skin reactions. | 8 weeks |
| Effectiveness | Percent change from baseline in lesional Eczema Area and Severity Index (EASI) score at Week 8. EASI is scored on a 0 - 6 scale with 0 being no eczema and 6 being 100% of the area affected by eczema. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) | Percentage of subjects achieving Investigator's Global Assessment (IGA) response of 'Clear' (Score 0) or 'Almost Clear' (Score 1) at Week 8. | 8 weeks |
| Eczema Area and Severity Index (EASI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kani Clinic | Tbilisi | 0160 | Georgia |
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| 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 |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| placebo ointment | Other | Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day. |
|
Percentage of subjects who achieve a ≥75% improvement from baseline in lesional EASI score at Week 8
| 8 weeks |
| Pruritis | Change from baseline in peak lesional pruritus (itching) Numeric Rating Scale (NRS) score at Week 8. NRS goes from 0 to 10; with 0 signifying no itching and 10 signifying worst itch imaginable. | 8 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |