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

Primary Purpose

Acneiform Eruptions

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cream containing JAK Inhibitor
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acneiform Eruptions focused on measuring EGFR, Acneiform Rash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cream containing JAK Inhibitor

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
November 2, 2021
Last Updated
February 28, 2023
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05120362
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acneiform Eruptions
Keywords
EGFR, Acneiform Rash

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cream containing JAK Inhibitor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cream containing JAK Inhibitor
Intervention Description
The study drug is a cream containing JAK Inhibitor.
Primary Outcome Measure Information:
Title
Proportion of grade 0 or 1 patients at Week 4
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of grade 0 or 1 patients at Week 2
Description
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
Time Frame
2 weeks
Title
Proportion of grade 0 or 1 patients at Week 6
Description
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
Time Frame
6 weeks
Title
Change of PRO (FACT-EGFR 14) from baseline at Week 4
Description
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
Time Frame
4 weeks
Title
Safety of study drug
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Xu, M.D.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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