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Last Updated: October 23, 2019

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CLINICAL TRIALS PROFILE FOR ISOTRETINOIN

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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isotretinoin

Condition Name

Condition Name for Isotretinoin
Intervention Trials
Neuroblastoma 24
Recurrent Neuroblastoma 8
Acne 7
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Condition MeSH

Condition MeSH for Isotretinoin
Intervention Trials
Neuroblastoma 36
Leukemia 7
Acne Vulgaris 4
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Clinical Trial Locations for Isotretinoin

Trials by Country

Trials by Country for Isotretinoin
Location Trials
United States 564
Canada 53
Australia 19
United Kingdom 11
Puerto Rico 7
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Trials by US State

Trials by US State for Isotretinoin
Location Trials
Pennsylvania 28
California 28
Texas 24
New York 24
Massachusetts 23
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Clinical Trial Progress for Isotretinoin

Clinical Trial Phase

Clinical Trial Phase for Isotretinoin
Clinical Trial Phase Trials
Phase 4 12
Phase 3 21
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Isotretinoin
Clinical Trial Phase Trials
Completed 54
Recruiting 19
Terminated 11
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Clinical Trial Sponsors for Isotretinoin

Sponsor Name

Sponsor Name for Isotretinoin
Sponsor Trials
National Cancer Institute (NCI) 37
Children's Oncology Group 10
M.D. Anderson Cancer Center 7
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Sponsor Type

Sponsor Type for Isotretinoin
Sponsor Trials
Other 97
NIH 43
Industry 25
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Serving leading biopharmaceutical companies globally:

McKesson
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Moodys
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Boehringer Ingelheim

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