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| Sponsors and Collaborators: |
Department of Veterans Affairs Ortho Dermatologics |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007631 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Basal Cell Carcinoma, Squamous Cell Skin Neoplasms |
Drug: Tretinoin 0.1% cream or placebo Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | CSP #402 - VA Topical Tretinoin Chemoprevention Trial |
| Enrollment: | 1131 |
| Study Start Date: | March 1998 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Topical Tretinoin
|
Drug: Tretinoin 0.1% cream or placebo |
|
2: Placebo Comparator
Placebo
|
Other: Placebo
Patients receive placebo for same amount of time
|
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Study Chair: | Martin A. Weinstock, MD | VA Medical Center, Providence |
More Information
| Responsible Party: | Department of Veterans Affairs ( Weinstock, Martin - Study Chair ) |
| Study ID Numbers: | 402 |
| Study First Received: | December 29, 2000 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00007631 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
NMSC nonmelanoma skin cancer topical tretinoin cream |
|
Keratolytic Agents Skin Diseases Tretinoin Neoplasms, Basal Cell Carcinoma, Basal Cell |
Neoplasms, Squamous Cell Skin Neoplasms Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
|
Neoplasms by Histologic Type Skin Diseases Antineoplastic Agents Carcinoma, Basal Cell Skin Neoplasms Pharmacologic Actions Carcinoma Keratolytic Agents Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Basal Cell Tretinoin Neoplasms, Squamous Cell Carcinoma, Squamous Cell Dermatologic Agents Neoplasms, Glandular and Epithelial |
