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A Phase II, Randomized, Double-Blind, Parallel Design Study to Evaluate ACZONE™ (Dapsone) Gel, 5% As a Treatment For Rash Related to the Human Epidermal Growth Factor Receptor 1 (HER1)/Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor Tarceva® (Erlotinib)

Phase 2
18 Years
Not Enrolling
Rash, Non-small-Cell Lung Cancer

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Trial Information

A Phase II, Randomized, Double-Blind, Parallel Design Study to Evaluate ACZONE™ (Dapsone) Gel, 5% As a Treatment For Rash Related to the Human Epidermal Growth Factor Receptor 1 (HER1)/Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor Tarceva® (Erlotinib)

This will be a randomized, double-blind, parallel design study in subjects treated with
Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to
be related to Tarceva. Only subjects who are not glucose-6-phosphate dehydrogenase (G6PD)
deficient, and who have locally advanced or metastatic NSCLC and have failed at least 1
prior chemotherapy regimen indicated for Tarceva treatment will be included. Subjects will
be screened and consented for the study within 3 days of initiating Tarceva therapy and will
be instructed to contact the Investigator immediately when signs or symptoms of rash appear
on the face. Subjects will be enrolled into the study only if a rash develops on the face
and it has been confirmed and evaluated against eligibility criteria for the study.

Once enrolled, subjects will be randomly assigned to apply either ACZONE or placebo to the
rash-affected areas of the face. Subjects will apply ACZONE / placebo treatment for 8 weeks,
even if symptoms of the rash resolve completely. Specific efficacy assessments will include
lesion counts, plaque area, erythema assessment, and pruritus assessment. Rash
characteristics will be monitored using National Cancer Institute (NCI) Common Terminology
Criteria Adverse Event (CTCAE) version 3.0 terms and severity descriptions and percentage of
facial surface area (FSA) affected. Investigators will evaluate the subject's overall
response to treatment according to a standardized multiple choice question. Throughout the
study, photographs of the face will be taken.

Safety will be followed for 10 weeks (8 weeks of therapy + 2 weeks of follow-up) by
monitoring adverse events, concomitant medications, and chemistry and hematology parameters.
Plasma dapsone and N-acetyl dapsone concentrations will be measured to determine systemic
exposure to the study treatment. Steady state plasma concentrations of erlotinib will also
be measured before and after initiating the study treatment to determine any potential
effects of ACZONE on pharmacokinetics of Tarceva.

Inclusion Criteria:

To be eligible for the study, subjects must fulfill all of the following criteria:

1. Be male or female ≥18 years of age (inclusive).

2. Have been prescribed Tarceva as a single agent to treat locally advanced or
metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.

3. Present with acute signs and symptoms of rash on the face that meet the following

1. Are suspected to be related to Tarceva,

2. Include at least 3 inflammatory lesions, and

3. Are less than CTCAE Grade 3 in severity.

4. Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life
expectancy of at least 4 months.

5. Sign an approved informed consent form for the study.

6. Be willing to comply with the protocol.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

1. A skin examination reveals the presence of another skin disease and/or condition
(excessive facial hair, excessive scarring, sunburn, or other disfigurement) located
on the face that, in the study physician's opinion, would confound the evaluation of
the rash.

2. A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit
of normal.

3. A diagnosis of anemia, defined as hemoglobin <9.5 g/dL.

4. Undergoing any current therapy for NSCLC other than Tarceva.

5. Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.

6. Treatment with topical antibiotics, topical steroids, and other topical treatments on
the face within 14 days of Day 0 (start of ACZONE/placebo study treatment).

7. Treatment with any systemic antibiotics within 7 days of Day 0 (start of
ACZONE/placebo study treatment).

8. Treatment with any systemic medication or therapy known to affect anti-inflammatory
responses within 30 days prior to Day 0 (start of ACZONE/placebo study treatment).
These medications include, but are not limited to, oral corticosteroids,
cyclosporine, and methotrexate. Short-term treatment with non-steroidal
anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is
acceptable, provided that exposure is limited to ≤7 days per course. Chronic low-dose
aspirin use is also acceptable.

9. Active participation in an experimental therapy study or received experimental
therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment).

10. A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens,
or any component of ACZONE.

11. A poor medical risk because of other systemic diseases or active uncontrolled

12. Women who: are lactating; have a positive pregnancy test at Day 0, or; if sexually
active and menstruating, are not practicing an adequate method of birth control.
Acceptable methods of birth control include intrauterine device (IUD); oral, dermal
("patch"), implanted or injected contraceptives; tubal ligation or hysterectomy
(medical documentation required); and/or barrier methods with spermicide. A
surgically sterile partner is not considered an adequate method of birth control.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics

Principal Investigator

Steven Garrett, MS, DDS

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

July 2007

Related Keywords:

  • Rash
  • Non-Small-Cell Lung Cancer
  • Tarceva
  • Rash
  • EGFR-1 Rash
  • erlotinib
  • Aczone
  • Dapsone
  • Non-small Cell Lung Cancer
  • subjects treated with Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to be related to Tarceva
  • Carcinoma, Non-Small-Cell Lung
  • Exanthema
  • Lung Neoplasms



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Northwestern University Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611-2941