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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

This study is currently recruiting participants.
Verified October 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Anna Chien, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01349556
First received: May 5, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.

Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.

Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.


Condition Intervention
Medication Reaction
 Drug: Tretinoin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Rashes
Drug Information available for: Tretinoin
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • EGFRi rash severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tretinoin pre-treatment Drug: Tretinoin
tretinoin 0.025% cream

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or over
  • Scheduled to begin treatment with an EGFR inhibitor drug

Exclusion Criteria:

  • Pregnant or nursing
  • History of bleeding disorder
  • History of keloids or large, thick, puffy-looking scars in the last 10 years
  • Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349556

Contacts
Contact: Sherry Leung 410-502-7546 ctrep@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Dept. of Dermatology Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Anna Chien, M.D.            
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Anna Chien, Assistant Professor, Co-Director, Cutaneous Translational Research Program, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01349556     History of Changes
Other Study ID Numbers: NA_00042104
Study First Received: May 5, 2011
Last Updated: October 29, 2012
Health Authority: United States: Johns Hopkins Medicine IRB

Keywords provided by Johns Hopkins University:
cancer
chemotherapy
EGFR inhibitors
tretinoin
EGFRi drug rash

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders
Tretinoin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013