Expired Study
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Durham, North Carolina 27705


Purpose:

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.


Study summary:

Primary Hypothesis: To determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer (NMSC) among high risk individuals (at least 2 NMSC?S in last 5 years). Secondary Hypothesis: Secondary objectives are: (a) to determine the long-term effect of topical tretinoin on the prevalence of premalignant actinic keratoses, and (b) to distinguish subpopulations in which topical tretinoin is particularly effective or ineffective, compared to the overall study population. Intervention: Apply Tretinoin 0.1% cream or placebo cream to face and ears twice a day. Primary Outcomes: New NMSC lesions on the face and ears. Number of actinic keratoses on the face and ears. Study Abstract: 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, 1200 patients with a recent history of squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over a four-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo. They will be followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences. Weinstock, M.A., Bingham, S.F., Cole, G.W., Eilers, D., Naylor, M.F., Kalivas, J., Taylor, J.R., Gladstone, H.B., Piacquadio, D.J., and DiGiovanna, J.J. Reliability of Counting Actinic Keratoses Before and After Brief Consensus Discussion. Arch Dermatol 137:1055-1058, 2001


Criteria:

Inclusion Criteria: High risk individuals (at least 2 NMSC?S in last 5 years). Exclusion Criteria: Exclusion criteria would include systemic retinoid treatment or systemic chemotherapy within the past six months; indices of very high mortality risk within 3 years (history of invasive noncutaneous malignancy within the past five years or metastatic cutaneous malignancy, or of other severe medical problems e.g. end-stage cardiac disease); known allergy or severe irritation reaction to tretinoin or the cream vehicle; special conditions predisposing to NMSC that may not be generally applicable (xeroderma pigmentosum, basal cell nevus syndrome, major organ transplant recipient, known arsenic exposure, PUVA photochemotherapy, mycosis fungoides, or prior or current radiation therapy involving the face, ears, or area of prior skin cancer), and likely inability to comply with the requirements of the trial as judged by the investigator. Incompetent patients and pregnant or nursing patients will be excluded


Study is Available At:


Original ID:

402


NCT ID:

NCT00007631


Secondary ID:


Study Acronym:


Brief Title:

Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer


Official Title:

CSP #402 - VA Topical Tretinoin Chemoprevention Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1131


Enrollment Type:

Actual


Overall Contact Information

Official Name:Martin A. Weinstock, MD
Study Chair
VA Medical Center, Providence

Study Dates

Start Date:March 1998
Completion Date:July 2006
Completion Type:Actual
Primary Completion Date:November 2004
Primary Completion Type:Actual
Verification Date:January 2009
Last Changed Date:January 29, 2009
First Received Date:December 29, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Long term effect of topical tretinoin on the prevalence of premalignant actinic keratoses
Time Frame:until the end of the study for a minimum of 2 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Tretinoin 0.1% cream or placebo
Arm Name:1
Intervention Type:Other
Name:Placebo
Description:Patients receive placebo for same amount of time
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Topical Tretinoin
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Placebo

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ortho Dermatologics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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