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Isotretinoin

Generic Name
Isotretinoin
Brand Names
Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane
Drug Type
Small Molecule
Chemical Formula
C20H28O2
CAS Number
4759-48-2
Unique Ingredient Identifier
EH28UP18IF
Background

Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.

Indication

Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.

Associated Conditions
Acne conglobata, Neuroblastoma (NB), Rosacea, Sezary Syndrome, Early Mycosis Fungoides (MF), Refractory Acne vulgaris, Severe Recalcitrant nodular acne
Clinical Trials
Related News

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

Phase 3
Completed
Conditions
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Interventions
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
First Posted Date
2007-12-05
Last Posted Date
2022-04-28
Lead Sponsor
Children's Oncology Group
Target Recruit Count
665
Registration Number
NCT00567567
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Valley Children's Hospital, Madera, California, United States

🇺🇸

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

and more 187 locations

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Phase 1
Terminated
Conditions
Glioblastoma Multiforme
Anaplastic Glioma
Interventions
Procedure: Surgical Resection
First Posted Date
2007-11-08
Last Posted Date
2024-08-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
55
Registration Number
NCT00555399
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Not Applicable
Conditions
Neuroblastoma
First Posted Date
2007-09-10
Last Posted Date
2015-07-16
Lead Sponsor
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Target Recruit Count
360
Registration Number
NCT00526318
Locations
🇩🇪

Klinikum Augsburg, Augsburg, Germany

🇩🇪

Evangelisches Krankenhauus Bielfeld, Biefeld, Germany

🇩🇪

Klinikum Duisburg, Duisburg, Germany

and more 64 locations

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

First Posted Date
2007-07-11
Last Posted Date
2021-07-06
Lead Sponsor
Children's Oncology Group
Target Recruit Count
464
Registration Number
NCT00499616
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

and more 186 locations

Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne

Phase 1
Completed
Conditions
Acne
First Posted Date
2006-12-28
Last Posted Date
2008-01-23
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Target Recruit Count
30
Registration Number
NCT00416585
Locations
🇮🇷

Shaheed Beheshti Medical University, Skin research center, Tehran, Iran, Islamic Republic of

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

Phase 3
Conditions
Neuroblastoma
First Posted Date
2006-12-13
Last Posted Date
2013-08-07
Lead Sponsor
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Target Recruit Count
642
Registration Number
NCT00410631
Locations
🇩🇪

Kinderklinik - Universitaetsklinikum Aachen, Aachen, Germany

🇩🇪

Klinikum Dortmund, Dortmund, Germany

🇩🇪

Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl, Cologne, Germany

and more 74 locations

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

Phase 3
Active, not recruiting
Conditions
Anaplastic Medulloblastoma
Medulloblastoma
Interventions
Procedure: Biospecimen Collection
Procedure: Lumbar Puncture
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
First Posted Date
2006-10-26
Last Posted Date
2024-01-26
Lead Sponsor
Children's Oncology Group
Target Recruit Count
379
Registration Number
NCT00392327
Locations
🇺🇸

Inova Fairfax Hospital, Falls Church, Virginia, United States

🇺🇸

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

🇵🇷

University Pediatric Hospital, San Juan, Puerto Rico

and more 182 locations

Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

Phase 1
Completed
Conditions
Adult Solid Neoplasm
Interventions
Other: Pharmacological Study
First Posted Date
2006-06-08
Last Posted Date
2018-04-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
51
Registration Number
NCT00334789
Locations
🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 2 locations

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

Phase 1
Terminated
Conditions
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions
First Posted Date
2006-05-11
Last Posted Date
2021-02-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
14
Registration Number
NCT00324740
Locations
🇺🇸

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Phase 1
Completed
Conditions
Childhood Acute Promyelocytic Leukemia (M3)
Childhood Atypical Teratoid/Rhabdoid Tumor
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Juvenile Myelomonocytic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Interventions
First Posted Date
2005-09-22
Last Posted Date
2014-06-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
60
Registration Number
NCT00217412
Locations
🇺🇸

Children's Oncology Group, Philadelphia, Pennsylvania, United States

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