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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00007631
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : January 30, 2009
Sponsor:
Collaborator:
Ortho Dermatologics
Information provided by:
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Carcinoma, Squamous Cell Skin Neoplasms Drug: Tretinoin 0.1% cream or placebo Other: Placebo Phase 3

Detailed Description:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CSP #402 - VA Topical Tretinoin Chemoprevention Trial
Study Start Date : March 1998
Actual Primary Completion Date : November 2004
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer
Drug Information available for: Tretinoin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Topical Tretinoin
 Drug: Tretinoin 0.1% cream or placebo
Placebo Comparator: 2
Placebo
 Other: Placebo
Patients receive placebo for same amount of time


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007631


Locations
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United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
US Department of Veterans Affairs
Ortho Dermatologics
Investigators
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Study Chair: Martin A. Weinstock, MD VA Medical Center, Providence
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weinstock, Martin - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007631    
Other Study ID Numbers: 402
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009
Keywords provided by VA Office of Research and Development:
NMSC
nonmelanoma skin cancer
topical tretinoin cream
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents