Who is sponsoring NCT00601640?

NCT00601640 is sponsored by University of Arizona.

What drugs are being tested in NCT00601640?

Interventions in NCT00601640: Diclofenac Na gel, Eflornithine HCL ointment.

What condition does NCT00601640 study?

NCT00601640 studies Other Benign Neoplasm of Skin, Unspecified.

Is NCT00601640 still recruiting?

NCT00601640 is currently completed. Last updated 2 February 2017.

Are results published for NCT00601640?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-02-02 · How we verify

NCT00601640

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm

Completed Phase 2 Results posted Last updated 2 February 2017

What this trial tests

Phase 2 trial testing Diclofenac Na gel in Other Benign Neoplasm of Skin, Unspecified in 184 participants. Completed in 1 December 2014.

Timeline

1 January 2007

Primary endpoint
1 February 2010

1 December 2014

Quick facts

Lead sponsor	University of Arizona
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	184
Start date	1 January 2007
Primary completion	1 February 2010
Estimated completion	1 December 2014
Sites	3 locations across United States

Drugs / interventions tested

Diclofenac Na gel — full drug profile →
Eflornithine HCL ointment

Conditions studied

Other Benign Neoplasm of Skin, Unspecified — all drugs for Other Benign Neoplasm of Skin, Unspecified →

Sponsor

University of Arizona

Who can join

40 and older, any sex, with Other Benign Neoplasm of Skin, Unspecified. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Changes in Putrescine Over 3 Months
Time frame: 3 months
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.
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Time frame: 3 months
Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Aging and immunotherapies: New horizons for the golden ages.
Hamilton JAG, Henry CJ. · · 2020 · cited 17× · PMID 35874875 · DOI 10.1002/aac2.12014
Recent Advances in Clinical Research for Skin Cancer Chemoprevention.
Tow R, Hanoun S, Andresen B, Shahid A, et al · · 2023 · cited 9× · PMID 37568635 · DOI 10.3390/cancers15153819

Verify or expand the search:

Other University of Arizona trials

Trials by the same sponsor.

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NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain · NA · not yet recruiting
NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy · suspended
NCT06567899 — Mechanistic Underpinnings of Preeclampsia · not yet recruiting
NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00601640 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Arizona
Last refreshed: 2 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00601640.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing