NCT05120362

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

November 2, 2021

Last Update Submit

February 28, 2023

Conditions

Acneiform Eruptions

Keywords

EGFRAcneiform Rash

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of grade 0 or 1 patients at Week 2

    2 weeks

  • Proportion of grade 0 or 1 patients at Week 6

    6 weeks

  • Change of PRO (FACT-EGFR 14) from baseline at Week 4

    4 weeks

  • Safety of study drug

    6 weeks

Study Arms (1)

Cream containing JAK Inhibitor

EXPERIMENTAL
Drug: Cream containing JAK Inhibitor

Interventions

Cream containing JAK InhibitorDRUG

The study drug is a cream containing JAK Inhibitor.

Cream containing JAK Inhibitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Related Publications (1)

  • You Q, Chen L, Li S, Liu M, Tian M, Cheng Y, Xia L, Li W, Yao Y, Li Y, Zhou Y, Ma Y, Lv D, Zhao L, Wang H, Wu Z, Hu J, Ju J, Jia C, Xu N, Luo J, Zhang S. Topical JAK inhibition ameliorates EGFR inhibitor-induced rash in rodents and humans. Sci Transl Med. 2024 Jun 19;16(752):eabq7074. doi: 10.1126/scitranslmed.abq7074. Epub 2024 Jun 19.

    PMID: 38896602DERIVED

MeSH Terms

Conditions

Acneiform Eruptions

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nan Xu, M.D.

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

November 3, 2021

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)