Advertisement

Topics

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

2014-08-27 03:57:15 | BioPortfolio

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.

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

Conditions

Carcinoma, Basal Cell

Intervention

Tretinoin 0.1% cream or placebo, Placebo

Location

Carl T. Hayden VA Medical Center
Phoenix
Arizona
United States
85012

Status

Completed

Source

Department of Veterans Affairs

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:15-0400

Clinical Trials [6276 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence

The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant thera...

Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors

Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .

Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up...

PubMed Articles [19168 Associated PubMed Articles listed on BioPortfolio]

Tretinoin (0.05% cream versus 5% peel) for photoaging and field cancerization of the forearms: randomized, evaluator-blinded, clinical trial.

Topical tretinoin cream is the gold standard treatment for skin aging, particularly photoaging. The purpose of tretinoin peel is to obtain similar results but in a shorter time, however there have bee...

Solitary plantar basal cell carcinoma.

Basal cell carcinoma is the most frequent skin cancer, generally located in hair-bearing, sunlight-exposed areas. Basal cell carcinoma usually occurs on the head and neck, but very rarely on extra-fac...

Genital basal cell carcinoma, a different pathogenesis from sun-exposed basal cell carcinoma? A case-control study of 30 cases.

Genital basal cell carcinoma (BCC) accounts for

Placebo analgesia persists during sleep: An experimental study.

Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...

Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects.

Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)

An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).

A patched receptor that may function redundantly with the PATCHED-1 RECEPTOR to modulate hedgehog signaling. It may also play a role in epidermal development and as a TUMOR SUPPRESSOR PROTEIN. Mutations in the patched-2 gene are associated with BASAL CELL NEVUS SYNDROME; CARCINOMA, BASAL CELL; and MEDULLOBLASTOMA.

More From BioPortfolio on "Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Skin cancers
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...


Searches Linking to this Trial