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

Not Applicable

Active, not recruiting

• Conditions: Acneiform Eruptions
• Interventions: Drug: Cream containing JAK Inhibitor

• Registration Number: NCT05120362
• Lead Sponsor: Shanghai East Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study Start: 2021-11-03
• Study First Posted: 2021-11-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cream containing JAK Inhibitor	Cream containing JAK Inhibitor	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China