Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007631
Status:
COMPLETED
Last Update Posted:
2009-01-30
First Post:
2000-12-29
Brief Title:
Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 402 - VA Topical Tretinoin Chemoprevention Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 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 andor basal cell carcinoma were enrolled at six participating centers over a four-year period and were randomly assigned to either 01 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
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 NMSCS 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 01 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 1000 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 andor basal cell carcinoma will be enrolled at six participating centers over a four-year period and will be randomly assigned to either 01 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 MA Bingham SF Cole GW Eilers D Naylor MF Kalivas J Taylor JR Gladstone HB Piacquadio DJ and DiGiovanna JJ Reliability of Counting Actinic Keratoses Before and After Brief Consensus Discussion Arch Dermatol 1371055-1058 2001
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 01 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 1000 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 andor basal cell carcinoma will be enrolled at six participating centers over a four-year period and will be randomly assigned to either 01 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 MA Bingham SF Cole GW Eilers D Naylor MF Kalivas J Taylor JR Gladstone HB Piacquadio DJ and DiGiovanna JJ Reliability of Counting Actinic Keratoses Before and After Brief Consensus Discussion Arch Dermatol 1371055-1058 2001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None