Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants

Joseph Tangrea; Brenda Edwards; Anne Hartman; Philip Taylor; Gary Peck; Stuart Salasche; Padman Menon; George Winton; Ramsey Mellette; Marshall Guill; June Robinson; Jere Guin; Howard Stoll

doi:10.1016/0197-2456(90)90020-3

Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants

Joseph Tangrea^*, Brenda Edwards, Anne Hartman, Philip Taylor, Gary Peck, Stuart Salasche, Padman Menon, George Winton, Ramsey Mellette, Marshall Guill, June Robinson, Jere Guin, Howard Stoll

^*Corresponding author for this work

Dermatology

Research output: Contribution to journal › Article › peer-review

16 Scopus citations

Abstract

The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.

Original language	English (US)
Pages (from-to)	433-450
Number of pages	18
Journal	Controlled Clinical Trials
Volume	11
Issue number	6
DOIs	https://doi.org/10.1016/0197-2456(90)90020-3
State	Published - Dec 1990

Funding

National Institutes of Health, National Cancer Institute (J.T.; B.E.; A.H.; P.T.; G.P.), Brooke Army Medical Center (S.S.), Portsmouth Naval Hospital (P.M.), Walter Reed Army Medical Center (G. W.), Fitzsimons Army Medical Center (R.M.), Eisenhower Army Medical Center (M.G.), Northwestern University (J.R.), University of Arkansas (J.G.), Roswell Park Memorial Institute (H.S.)

Keywords

basal cell carcinoma
chemoprevention
design
isotretinoin

ASJC Scopus subject areas

Pharmacology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/0197-2456(90)90020-3

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Tangrea, J., Edwards, B., Hartman, A., Taylor, P., Peck, G., Salasche, S., Menon, P., Winton, G., Mellette, R., Guill, M., Robinson, J., Guin, J., & Stoll, H. (1990). Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants. Controlled Clinical Trials, 11(6), 433-450. https://doi.org/10.1016/0197-2456(90)90020-3

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abstract = "The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.",

keywords = "basal cell carcinoma, chemoprevention, design, isotretinoin",

author = "Joseph Tangrea and Brenda Edwards and Anne Hartman and Philip Taylor and Gary Peck and Stuart Salasche and Padman Menon and George Winton and Ramsey Mellette and Marshall Guill and June Robinson and Jere Guin and Howard Stoll",

note = "Funding Information: National Institutes of Health, National Cancer Institute (J.T.; B.E.; A.H.; P.T.; G.P.), Brooke Army Medical Center (S.S.), Portsmouth Naval Hospital (P.M.), Walter Reed Army Medical Center (G. W.), Fitzsimons Army Medical Center (R.M.), Eisenhower Army Medical Center (M.G.), Northwestern University (J.R.), University of Arkansas (J.G.), Roswell Park Memorial Institute (H.S.)",

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doi = "10.1016/0197-2456(90)90020-3",

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Tangrea, J, Edwards, B, Hartman, A, Taylor, P, Peck, G, Salasche, S, Menon, P, Winton, G, Mellette, R, Guill, M, Robinson, J, Guin, J & Stoll, H 1990, 'Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants', Controlled Clinical Trials, vol. 11, no. 6, pp. 433-450. https://doi.org/10.1016/0197-2456(90)90020-3

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T1 - Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants

AU - Tangrea, Joseph

AU - Edwards, Brenda

AU - Hartman, Anne

AU - Taylor, Philip

AU - Peck, Gary

AU - Salasche, Stuart

AU - Menon, Padman

AU - Winton, George

AU - Mellette, Ramsey

AU - Guill, Marshall

AU - Robinson, June

AU - Guin, Jere

AU - Stoll, Howard

N1 - Funding Information: National Institutes of Health, National Cancer Institute (J.T.; B.E.; A.H.; P.T.; G.P.), Brooke Army Medical Center (S.S.), Portsmouth Naval Hospital (P.M.), Walter Reed Army Medical Center (G. W.), Fitzsimons Army Medical Center (R.M.), Eisenhower Army Medical Center (M.G.), Northwestern University (J.R.), University of Arkansas (J.G.), Roswell Park Memorial Institute (H.S.)

PY - 1990/12

Y1 - 1990/12

N2 - The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.

AB - The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.

KW - basal cell carcinoma

KW - chemoprevention

KW - design

KW - isotretinoin

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JO - Controlled Clinical Trials

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ER -

Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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