Clinical trial · Interventional
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
Chemoprevention Trial of Acitretin Versus Placebo in Patients at High Risk for Basal Cell Carcinoma or Squamous Cell Carcinoma
NCT00644384CI-TRIAL-00004830completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acitretin may stop cancer from growing in patients at high risk for basal cell carcinoma or squamous cell carcinoma of the skin. PURPOSE: This randomized trial is studying how well acitretin works in preventing skin cancer in patients at high risk for skin cancer.
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 |
|---|---|---|---|
| Non-melanomatous Skin Cancer | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acitretin | Drug | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| northern blotting | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of new non-melanoma skin cancer development
Secondary outcomes (3)
- measure
- Time to new non-melanoma skin cancer development
- measure
- Gene expression (RAR/RXR, Fos/Jun, and AP-1)
- measure
- HPV DNA detection, sequencing, and quantification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * At high risk for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, defined as a prior history of ≥ 3 nonmelanoma skin lesions * All visible BCC or SCC must have been resected prior to study entry PATIENT CHARACTERISTICS: * Life expectancy \> 5 years * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * SGOT ≤ 2 times ULN * Creatinine ≤ 1.5 times ULN * Cholesterol \< 250 mg/dL * Triglycerides \< 2.5 times ULN * Not pregnant * No history of significant, uncontrolled hyperlipidemia * No history of oral retinoid intolerance * No history of other significant medical condition that, in the opinion of the physician, would contraindicate retinoid use PRIOR CONCURRENT THERAPY: * More than 1 year since prior retinoid therapy * At least 4 weeks since prior and no other concurrent use of oral vitamin A supplements, topical retinoids, or other potentially irritating skin preparations * Concurrent multivitamin supplements allowed * No prior organ transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.