Clinical trial · Interventional
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms
- 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 therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.
Conditions
Conditions (2)
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 | — | UNRESOLVED | — |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eflornithine | Drug | — | UNRESOLVED |
| triamcinolone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Diagnosis of actinic keratosis At least 3 clinically visible lesions on each lower posterior forearm Lesions must be discrete and quantifiable No prior or concurrent skin cancer on forearms Prior skin cancer (other than melanoma) on an area other than the forearms allowed unless chronic recurrent lesions indicate immunosuppression Concurrent skin cancer on an area other than the forearms allowed if active lesion previously excised PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious concurrent illness No immunosuppression due to medication or disease No invasive cancer (including melanoma) within the past 5 years Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 28 days prior to and during study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior systemic chemotherapy At least 6 months since prior fluorouracil (5-FU) to forearms Prior or concurrent 5-FU to the face allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other supplement) At least 6 months since prior tretinoin to forearms Prior or concurrent tretinoin to the face allowed No concurrent mega-doses of vitamins No other concurrent investigational drug or device
References
Publications (0)
Data not yet available