Skip to main content
OpenTrials
Completed

NCT Number: NCT00718315

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fortaleza, Ceará, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
  • eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

Exclusion criteria

  • presence of skin rash or other signs of skin toxicity;
  • treatment with any systemic or intranasal antibiotic within 7 days before randomization;
  • treatment with other topical formulation within 14 days before randomization;
  • other anticancer therapy in addition to Tarceva.

Treatment and study plan

erlotinib [Tarceva]

Drug

150mg po daily

fusidic acid [Verutex]

Drug

topical, daily for 30 days.

erythromycin [Eritex]

Drug

topical, daily for 30 days.

Fisiogel

Drug

topical, daily for 30 days

Primary outcomes

  1. Percentage of Participants Who Develop Skin Rash

    Time frame: 30 Days

    Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").

  2. Percentage of Participants With Skin Rash Stratified by Severity Grade

    Time frame: 30 Days

    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death

Secondary outcomes

  1. Time to Appearance of Skin Rash

    Time frame: Days 0, 15, and 30

    Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE

  2. Percentage of Participants With Erythema

    Time frame: Days 0, 15, and 30

    Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries

  3. Percentage of Participants With Pruritus

    Time frame: Days 0, 15, and 30

    Pruritus is defined as intense localized itching

  4. Percentage of Participants With Pain

    Time frame: Days 0, 15, and 30

    Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli

  5. Percentage of Participants With Erythema Stratified by Severity Grade

    Time frame: 30 Days

    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.

  6. Percentage of Participants With Pruritus Stratified by Severity Grade

    Time frame: 30 Days

    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.

  7. Percentage of Participants With Pain Stratified by Severity Grade

    Time frame: 30 Days

    The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2008
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.