A Study to Evaluate JAK Inhibitor Cream in EGFR-inhibitor-induced Skin Rash

An Investigator-initiated Trial to Evaluate the Efficacy and Safety of JAK Inhibitor Cream for the Treatment of EGFR-inhibitor-induced Skin Rash

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acneiform Eruptions
• Intervention / Treatment: Drug: Cream containing JAK Inhibitor

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cream containing JAK Inhibitor	Drug: Cream containing JAK Inhibitor; The study drug is a cream containing JAK Inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: Nan Xu, M.D., Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: EGFR; Acneiform Rash
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema; Acneiform Eruptions; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors
• Other Study ID Numbers: SHEH002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No