Acneiform Eruptions
Conditions
Keywords
EGFR, Acneiform Rash
Brief summary
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.
Interventions
DRUGCream containing JAK Inhibitor
The study drug is a cream containing JAK Inhibitor.
Sponsors
Shanghai East Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Pathologically confirmed cancer receiving EGFRI-based therapy (monotherapy or as part of a combination therapy regimen). * Skin rash causally related to EGFRI therapy of grade 1 or higher (according to MESTT criteria). * ECOG performance score \< 2. * Able to use topical medications and complete questionnaires reliably with or without assistance. * Life expectancy of greater than 6 months. * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Use of any other topical medications in the treatment areas (face) within 7 days prior to randomization or duing the study. * Use of Tetracycline (e.g. minocycline, doxycycline) within 14 days prior to randomization or duing the study. * Use of other cancer medications known to result in skin rash in the face or upper chest/upper back area within 4 weeks prior to randomization or duing the study. * Known hypersentitivity to JAK inhibitors. * With other skin disorders that may affect efficacy evaluation, including but not limited to: eczema, psoriasis, etc. * Uncontrolled intercurrent illness. * Significantly abnormal lab test. * Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of grade 0 or 1 patients at Week 4 | 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of grade 0 or 1 patients at Week 2 | 2 weeks | 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 |
| Proportion of grade 0 or 1 patients at Week 6 | 6 weeks | 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 |
| Change of PRO (FACT-EGFR 14) from baseline at Week 4 | 4 weeks | 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 |
| Safety of study drug | 6 weeks | 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 |
Countries
China
Outcome results
None listed