NCT03047863

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

December 2, 2016

Last Update Submit

February 8, 2017

Conditions

Drug-Related Side Effects and Adverse ReactionsEpidermal Growth Factor

Keywords

Epidermal Growth Factor

Outcome Measures

Primary Outcomes (1)

  • The change of severity of acneform eruption induced by EGFR inhibitors

    To evaluate the severity of acneiform eruption, the investigators take a photograph of full face. The number of inflammatory and noninflammatory lesions will be counted and accessed the severity based on the Korean Acne Grading System(KAGS).

    Baseline, 1 week, 2 weeks, 4 weeks

Secondary Outcomes (5)

  • change of skin hydration

    Baseline, 1 week, 2 weeks, 4 weeks

  • change of sebum production

    Baseline, 1 week, 2 weeks, 4 weeks

  • Investigator's global assessment score

    Baseline, 1 week, 2 weeks, 4 weeks

  • Patient's global assessment score

    Baseline, 1 week, 2 weeks, 4 weeks

  • The side effects of product

    Baseline, 1 week, 2 weeks, 4 weeks

Study Arms (2)

Repair Control EGF®

EXPERIMENTAL

EGF cream was applied. Half of face was treated with emollient containing EGF.

Drug: Repair Control EGF®

Cream without rhEGF

PLACEBO COMPARATOR

Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF.

Drug: Cream without rhEGF

Interventions

Repair Control EGF®DRUG

A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 4 weeks. EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)

Also known as: EGF cream containing 10 ppm of rhEGF
Repair Control EGF®
Cream without rhEGFDRUG

A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 4 weeks. Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Cream without rhEGF

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
  • Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
  • Patients who can understand and follow the protocol
  • Patients who spontaneously agreed to the study

You may not qualify if:

  • NCI-CTCAE grade 4 patients requiring systemic drug therapy
  • Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
  • Patients with existing acne history
  • Patients who have already received anti-EGFR therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Jung Min Bae, MD, PhD

    The Catholic University of Korea

    STUDY CHAIR

Central Study Contacts

Jung Min Bae, MD, PhD

CONTACT

82-31-249-8209jminbae@gmail.com

Ho jung An, MD, PhD

CONTACT

82-10-8737-4285strhojung@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 2, 2016

First Posted

February 9, 2017

Study Start

November 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

KR(1)