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

• Sponsor: Shanghai East Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05120362
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acneiform Eruptions	Drug: Cream containing JAK Inhibitor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 3, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of grade 0 or 1 patients at Week 4 [4 weeks]

   Determine the proportion of patients receiving JAK Inhibitor Cream or Vehicle who have achieved grade 0 or 1 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

1. Proportion of grade 0 or 1 patients at Week 2 [2 weeks]

   Determine the proportion of patients receiving JAK Inhibitor Cream or Vehicle who have achieved grade 0 or 1 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. Proportion of grade 0 or 1 patients at Week 6 [6 weeks]

   Determine the proportion of patients receiving JAK Inhibitor Cream or Vehicle who have achieved grade 0 or 1 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

3. 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 or Vehicle at Week 4

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hospital	Shanghai	Shanghai	China	200120

Sponsors and Collaborators

• Shanghai East Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai East Hospital
• ClinicalTrials.gov Identifier: NCT05120362
• Other Study ID Numbers: SHEH002
• First Posted: Nov 15, 2021
• Last Update Posted: Jun 24, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai East Hospital: EGFR; Acneiform Rash
• Additional relevant MeSH terms: Exanthema; Acneiform Eruptions; Janus Kinase Inhibitors

Study Results

No Results Posted as of Jun 24, 2022