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Epidermal growth factor receptor inhibitors (EGFRIs) are widely used targeted agents that have been approved for the treatment of various tumor types. In some clinical studies with EGFRIs, the incidence of dermatology AE, the skin rash, is reportedly as high as 95%, which profoundly impact the patients' quality of life. However no treament for onset skin rash has been approved to be effective by any clinical trial yet. Janus kinase (JAK) inhibitor, has been approved for or studied in a variety of skin conditions such as alopecia areata, atopic dermatitis, and psoriasis. Thus the investigators intend to evaluate the efficacy and safety of JAK inhibitor cream for the treatment of EGFRIs-induced skin rash in cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cream containing JAK Inhibitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cream containing JAK Inhibitor | Drug | The study drug is a cream containing JAK Inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grade 0 or 1 patients at Week 4 | Determine the proportion of patients receiving JAK Inhibitor Cream who have achieved 1 or 2 grade(s) decrease in skin rash (according to MASCC EGFR Inhibitor Skin Toxicity Tool - the MESTT criteria for Papulopustular Eruption, which includes 4 grades, Grade 3 as the most severe condition and Grade 0 as no symptom) at Week 4 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grade 0 or 1 patients at Week 2 | Determine the proportion of patients receiving JAK Inhibitor Cream who have achieved 1 or 2 grade(s) decrease in skin rash (according to MASCC EGFR Inhibitor Skin Toxicity Tool - the MESTT criteria for Papulopustular Eruption, which includes 4 grades, Grade 3 as the most severe condition and Grade 0 as no symptom) at Week 2 | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nan Xu, M.D. | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38896602 | Derived | You Q, Chen L, Li S, Liu M, Tian M, Cheng Y, Xia L, Li W, Yao Y, Li Y, Zhou Y, Ma Y, Lv D, Zhao L, Wang H, Wu Z, Hu J, Ju J, Jia C, Xu N, Luo J, Zhang S. Topical JAK inhibition ameliorates EGFR inhibitor-induced rash in rodents and humans. Sci Transl Med. 2024 Jun 19;16(752):eabq7074. doi: 10.1126/scitranslmed.abq7074. Epub 2024 Jun 19. |
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| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Proportion of grade 0 or 1 patients at Week 6 | Determine the proportion of patients receiving JAK Inhibitor Cream who have achieved 1 or 2 grade(s) decrease in skin rash (according to MASCC EGFR Inhibitor Skin Toxicity Tool - the MESTT criteria for Papulopustular Eruption, which includes 4 grades, Grade 3 as the most severe condition and Grade 0 as no symptom) at Week 6 | 6 weeks |
| Change of PRO (FACT-EGFR 14) from baseline at Week 4 | Determine the Change of PRO (according to FACT-EGFR 14 Questionnaire, which includes 14 QoL questions & each scoring from 0 to 4, 4 as the most severe condition and 0 as no symptom) from baseline in patients receiving JAK Inhibitor Cream at Week 4 | 4 weeks |
| Safety of study drug | Safety of study drug as determined by the number of participants with abnormal laboratory values and/or Adverse Events that are related to study treatment, especially local irritation | 6 weeks |