RashPhase 2NCT00343187
A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash
A Phase 2 study testing ACZONE (dapsone) Gel, 5% in people with Rash and Non-small-Cell Lung Cancer, run by Allergan at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rash, Non-small-Cell Lung Cancer
- What is being tested?
- ACZONE (dapsone) Gel, 5%
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, subjects must fulfill all of the following criteria:
- Be male or female ≥18 years of age (inclusive).
- Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.
- Present with acute signs and symptoms of rash on the face that meet the following criteria:
- Are suspected to be related to Tarceva,
- Include at least 3 inflammatory lesions, and
Show all 10Show fewer
- Are less than CTCAE Grade 3 in severity.
- Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months.
- Sign an approved informed consent form for the study.
- Be willing to comply with the protocol.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- 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.
- A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal.
- A diagnosis of anemia, defined as hemoglobin <9.5 g/dL.
- Undergoing any current therapy for NSCLC other than Tarceva.
- Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.
Show all 13Show fewer
- 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).
- Treatment with any systemic antibiotics within 7 days of Day 0 (start of ACZONE/placebo study treatment).
- 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.
- Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment).
- A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens, or any component of ACZONE.
- A poor medical risk because of other systemic diseases or active uncontrolled infections.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611-2941
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: 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)
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face
Read the detailed description
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.
- Conditions
- Rash, Non-small-Cell Lung Cancer
- Being tested
- ACZONE (dapsone) Gel, 5%, Vehicle Control
- Keywords
- 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
- Medical subject headings
- Exanthema, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZONE (dapsone) Gel, 5%Drug
Vehicle ControlDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics
Secondary outcomes (1)
Efficacy: Lesion counts; Plaque area; % of FSA affected; Erythema Score; Pruritus VAS Score; CTCAE v3.0 Grade for rash; Proportion of subjects who have rash on the face that worsens to specific category.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Garrett, MS, DDS, Study director, QLT USA, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343187
- Sponsor's protocol ID
- ACZ EGFR 01
- Status last verified
- May 2011
- First submitted
- 20 Jun 2006
- Last updated
- 30 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00343187
- Acronym / sponsor ID
- ACZ EGFR 01
- Conditions
- Rash, Non-small-Cell Lung Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be male or female ≥18 years of age (inclusive).
- Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.
- Present with acute signs and symptoms of rash on the face that meet the following criteria:
- Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months.
- Sign an approved informed consent form for the study.
Key exclusion criteria (13 listed)
- 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.
- A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal.
- A diagnosis of anemia, defined as hemoglobin <9.5 g/dL.
- Undergoing any current therapy for NSCLC other than Tarceva.
- Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACZONE (dapsone) Gel, 5% | Drug | – |
| Vehicle Control | Drug | – |
Primary outcome
Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics
1 secondary outcome
Efficacy: Lesion counts; Plaque area; % of FSA affected; Erythema Score; Pruritus VAS Score; CTCAE v3.0 Grade for rash; Proportion of subjects who have rash on the face that worsens to specific category.
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
- QLT Inc. Home PageLink provided by the sponsor.
Related trials for Rash
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Garrett, MS, DDS study director
QLT USA, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACZONE (dapsone) Gel, 5% in people with Rash and Non-small-Cell Lung Cancer, run by Allergan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2011.