Clinical trial · Interventional
Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)
Pilot Study of Acitretin for Treatment of Erlotinib-induced Skin Rash
NCT01299220CI-TRIAL-00008927withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to enroll subjects by sponsor deadline
Summary
Brief summary (as posted)
This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash caused by the chemotherapy drug, erlotinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Rash | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acitretin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Lesion Counts
- timeFrame
- Baseline
- description
- Lesion counts of the identified area of worst involvement will be done in a 5x5 cm area. All subsequent measurements will be done in the same 5x5 cm area.
- measure
- Lesion counts
- timeFrame
- Change from baseline at week 1
- description
- Lesion counts in area of worst involvement in 5x5 cm area
- measure
- Lesion counts
- timeFrame
- Change from baseline at week 2
- description
- Lesion count is performed in the worst area of involvement in 5x5 cm area
- measure
- Lesion counts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age and older at the time of study enrollment. * Started routine clinical, palliative, or experimental (off-label) treatment with erlotinib for solid tumors and have developed Grade 2 or higher skin toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.02. * Failed therapy with a two-week course of antibiotic (doxycycline 100 mg twice daily, or cephalexin 250 mg twice daily in patients allergic to doxycycline). * Willing and able to provide verbal and written informed consent * If reproductive potential, both males and females,must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to enrollment. Exclusion Criteria: * Pregnant or breast-feeding females. * Known or suspected sensitivity to study medication. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or worse. * Treatment with a non-approved or investigational drug (with the exception of erlotinib used in an experimental setting) within 30 days prior to Day 1 of study treatment. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness. * Bilirubin greater than or equal to three times the upper limit of normal. Sexually active women of childbearing potential must use an effective method of birth
References
Publications (0)
Data not yet available
No reference posted for this study.