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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR ISOTRETINOIN


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All Clinical Trials for Isotretinoin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000764 ↗ Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection. Completed Hoffmann-La Roche Phase 1 1969-12-31 PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
NCT00000764 ↗ Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection. Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
NCT00001073 ↗ Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
NCT00002506 ↗ Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer Completed Cancer Biotherapy Research Group Phase 2 1992-08-01 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers. PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isotretinoin

Condition Name

Condition Name for Isotretinoin
Intervention Trials
Neuroblastoma 26
Acne 10
Acne Vulgaris 10
Recurrent Neuroblastoma 8
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Condition MeSH

Condition MeSH for Isotretinoin
Intervention Trials
Neuroblastoma 38
Acne Vulgaris 19
Leukemia 7
COVID-19 7
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Clinical Trial Locations for Isotretinoin

Trials by Country

Trials by Country for Isotretinoin
Location Trials
United States 665
Canada 61
Australia 28
United Kingdom 11
Puerto Rico 8
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Trials by US State

Trials by US State for Isotretinoin
Location Trials
Pennsylvania 32
California 32
Texas 27
New York 27
Massachusetts 26
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Clinical Trial Progress for Isotretinoin

Clinical Trial Phase

Clinical Trial Phase for Isotretinoin
Clinical Trial Phase Trials
Phase 4 18
Phase 3 26
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Isotretinoin
Clinical Trial Phase Trials
Completed 70
Active, not recruiting 14
Not yet recruiting 14
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Clinical Trial Sponsors for Isotretinoin

Sponsor Name

Sponsor Name for Isotretinoin
Sponsor Trials
National Cancer Institute (NCI) 38
Children's Oncology Group 11
M.D. Anderson Cancer Center 7
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Sponsor Type

Sponsor Type for Isotretinoin
Sponsor Trials
Other 153
NIH 45
Industry 34
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