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NCT00601640 · ClinicalTrials.gov registry record · Phase 2

Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

A Phase 2 study of Other Benign Neoplasm of Skin, Unspecified, sponsored by University of Arizona.

Completed
Registry status
Phase 2
Development phase
184
Enrollment target
3
Study locations

NCT00601640: Completed Phase 2 study of Other Benign Neoplasm of Skin, Unspecified, sponsored by University of Arizona.

NCT00601640 is a Phase 2 study of Other Benign Neoplasm of Skin, Unspecified that has completed, run by University of Arizona. The registered enrollment target is 184 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00601640, a Phase 2 study of Other Benign Neoplasm of Skin, Unspecified, has completed, sponsored by University of Arizona.

COMPLETED
Registry status
Phase 2
Development phase
184 participants
Enrollment target
3
Study locations

Study Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.

Primary Outcome

Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant.

Interventions

  • DRUG Diclofenac Na gel
  • DRUG Eflornithine HCL ointment

Study Locations (3)

Arizona

  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea - Tucson
  • Veterans Affairs Medical Center - Tucson - Tucson
  • Arizona Cancer Center at University of Arizona Health Sciences Center - Tucson

Trial Details

FieldValue
Enrollment Target 184 participants
Start Date 2007-01
Est. Completion 2014-12
Phase Phase 2
University of Arizona

349 total trials

What the finished NCT00601640 record still lists

NCT00601640 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).

The record links to 1 condition, with Other Benign Neoplasm of Skin, Unspecified appearing as the primary indexed condition, and to 2 interventions - of which Diclofenac Na gel is the first listed.

NCT00601640 reports a single indexed study location in Arizona.

Frequently Asked Questions

What is clinical trial NCT00601640 about?

NCT00601640 is a clinical study titled "Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin". RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared wi...

What is the current status of trial NCT00601640?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2007-01. Estimated completion is 2014-12.

What conditions does trial NCT00601640 study?

This clinical trial studies the following conditions: Other Benign Neoplasm of Skin, Unspecified.

What interventions are being tested in trial NCT00601640?

The interventions under investigation include: Diclofenac Na gel (DRUG), Eflornithine HCL ointment (DRUG).

Who is sponsoring clinical trial NCT00601640?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00601640 being conducted?

This trial has 3 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00601640's enrollment target sits among peer trials

184 360th of 2000 higher than 1,638 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00601640, the US trial registry maintained by the National Library of Medicine. NCT00601640 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.