NCT00007631

Brief Summary

One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell and/or basal cell carcinoma were enrolled at six participating centers over a four-year period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,131

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

6.7 years

First QC Date

December 29, 2000

Last Update Submit

January 29, 2009

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellSkin Neoplasms

Keywords

NMSCnonmelanoma skin cancertopical tretinoin cream

Outcome Measures

Primary Outcomes (1)

  • Long term effect of topical tretinoin on the prevalence of premalignant actinic keratoses

    until the end of the study for a minimum of 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Topical Tretinoin

Drug: Tretinoin 0.1% cream or placebo

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Tretinoin 0.1% cream or placeboDRUG
1
PlaceboOTHER

Patients receive placebo for same amount of time

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High risk individuals (at least 2 NMSC?S in last 5 years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Carl T. Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

Related Publications (2)

  • Weinstock MA, Bingham SF, Lew RA, Hall R, Eilers D, Kirsner R, Naylor M, Kalivas J, Cole G, Marcolivio K, Collins J, Digiovanna JJ, Vertrees JE; Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) Trial Group. Topical tretinoin therapy and all-cause mortality. Arch Dermatol. 2009 Jan;145(1):18-24. doi: 10.1001/archdermatol.2008.542.

    PMID: 19153339DERIVED

  • Dore DD, Lapane KL, Trivedi AN, Mor V, Weinstock MA. Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial. Ann Intern Med. 2009 Jan 6;150(1):9-18. doi: 10.7326/0003-4819-150-1-200901060-00004.

    PMID: 19124815DERIVED

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellSkin Neoplasms

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Martin A. Weinstock, MD

    VA Medical Center, Providence

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

December 29, 2000

First Posted

January 1, 2001

Study Start

March 1, 1998

Primary Completion

November 1, 2004

Study Completion

July 1, 2006

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

US(7)