Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00498992

Enrollment

Registered

2007-07-11

Start date

2006-07-31

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

dermatologic complications, unspecified adult solid tumor, protocol specific

Brief summary

RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer. PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer. Secondary * Determine the efficacy of this drug in reducing the severity of rash in these patients. * Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients. * Determine the tolerability of this drug in these patients. OUTLINE: This is a prospective study. * Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment. * Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.

Interventions

DIETARY_SUPPLEMENTcollagen/aloe vera/vitamin E/lidocaine topical hydrogel

Study design

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of cancer * Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial PATIENT CHARACTERISTICS: * Not pregnant or nursing * No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel * No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other concurrent topical facial creams or lotions

Design outcomes

Primary

Measure	Time frame
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching	—

Secondary

Measure	Time frame
Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash	—
Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026