Clinical trial NCT05120362: A Study to Evaluate JAK Inhibitor Cream in EGFR-inhibitor-induced Skin Rash
Official title: An Investigator-initiated Trial to Evaluate the Efficacy and Safety of JAK Inhibitor Cream for the Treatment of EGFR-inhibitor-induced Skin Rash
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acneiform Eruptions
Keywords: EGFR
Acneiform Rash
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of grade 0 or 1 patients at Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of grade 0 or 1 patients at Week 2
timeFrame: 2 weeks
measure: Proportion of grade 0 or 1 patients at Week 6
timeFrame: 6 weeks
measure: Change of PRO (FACT-EGFR 14) from baseline at Week 4
timeFrame: 4 weeks
measure: Safety of study drug
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Nan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: