Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00007631
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase Phase 3
Start date March 1998
Completion date July 2006

See also
  Status Clinical Trial Phase
Recruiting NCT02743832 - A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma. N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Completed NCT00389727 - Simultaneous Integrated Boost (SIB)- IMRT Phase 2
Recruiting NCT02328391 - STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE N/A
Completed NCT00875381 - Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin N/A
Completed NCT00534950 - Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck N/A
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT01362127 - Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia Phase 2
Completed NCT00240682 - Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR Phase 2
Terminated NCT02254044 - Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus Phase 1
Active, not recruiting NCT00829192 - Phase II AK Study in Organ Transplant Patients Phase 2
Completed NCT00539630 - TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN Phase 3
Completed NCT00313027 - Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation N/A
Recruiting NCT04564989 - Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Not yet recruiting NCT06094829 - Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Active, not recruiting NCT02664935 - National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer Phase 2
Terminated NCT02438995 - Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 1