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
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
- First Posted Date
- 2013-10-25
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Target Recruit Count
- 76
- Registration Number
- NCT01969058
- Locations
- 🇺🇸
601 University of California, Los Angeles CARE Center CRS, Los Angeles, California, United States
🇺🇸107 Brigham and Women's Hosp. ACTG CRS, Boston, Massachusetts, United States
🇺🇸3203 Greensboro CRS, Greensboro, North Carolina, United States
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
- First Posted Date
- 2013-06-27
- Last Posted Date
- 2013-06-27
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Target Recruit Count
- 35
- Registration Number
- NCT01888289
- Locations
- 🇺🇸
AAI, Quadrangle Drive, Chapel Hill,, North Carolina, United States
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
- First Posted Date
- 2013-06-27
- Last Posted Date
- 2013-06-27
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Target Recruit Count
- 61
- Registration Number
- NCT01888224
- Locations
- 🇮🇳
Lambda Therapeutic Research Ltd.,, Ahmedabad, Gujarat, India
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
- First Posted Date
- 2013-06-27
- Last Posted Date
- 2013-06-27
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Target Recruit Count
- 41
- Registration Number
- NCT01888341
- Locations
- 🇺🇸
AAI, Quadrangle Drive, Chapel Hill,, North Carolina, United States
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
- First Posted Date
- 2013-06-27
- Last Posted Date
- 2013-06-27
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Target Recruit Count
- 26
- Registration Number
- NCT01888328
- Locations
- 🇺🇸
AAI, Quadrangle Drive, Chapel Hill,, North Carolina, United States
Bioequivalence Study for an Isotretinoin
- First Posted Date
- 2013-05-29
- Last Posted Date
- 2017-07-18
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 36
- Registration Number
- NCT01863615
- Locations
- 🇲🇽
GSK Investigational Site, Monterrey, Nuevo León, Mexico
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
- First Posted Date
- 2013-05-23
- Last Posted Date
- 2013-06-19
- Lead Sponsor
- Pierre Fabre Dermatology
- Target Recruit Count
- 45
- Registration Number
- NCT01861626
Therapy for Children With Advanced Stage Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Procedure: peripheral blood stem cell harvestProcedure: surgical resectionBiological: peripheral blood stem cell transplantationBiological: natural killer cell infusionRadiation: radiation therapyDevice: CliniMACS
- First Posted Date
- 2013-05-20
- Last Posted Date
- 2025-03-10
- Lead Sponsor
- St. Jude Children's Research Hospital
- Target Recruit Count
- 153
- Registration Number
- NCT01857934
- Locations
- 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
- Conditions
- Recurrent NeuroblastomaRefractory Neuroblastoma
- Interventions
- Other: Laboratory Biomarker AnalysisOther: Pharmacological Study
- First Posted Date
- 2012-10-22
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 27
- Registration Number
- NCT01711554
- Locations
- 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)
- First Posted Date
- 2012-10-05
- Last Posted Date
- 2020-07-14
- Lead Sponsor
- St. Anna Kinderkrebsforschung
- Target Recruit Count
- 288
- Registration Number
- NCT01701479
- Locations
- 🇪🇸
Hospital Universitario La Fe, Valencia, Spain
🇮🇹Gaslini Children's Hospital, Genova, Italy
🇫🇷Institut Gustave Roussy, Villejuif, France
Drug Development Updates
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