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

Acneiform Eruptions Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05120362
• Other study ID #: SHEH002
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2023
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older.

• Pathologically con?rmed 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.

Related Conditions & MeSH terms

• Acneiform Eruptions
• Exanthema

Intervention

Drug:
• Cream containing JAK Inhibitor
The study drug is a cream containing JAK Inhibitor.

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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