Isotretinoin

Generic Name: Isotretinoin

Brand Names: Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₈O_₂

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

ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

Phase 1

Completed

Conditions: Neuroblastoma

Interventions: Biological: ch14.18 -NCI
Biological: ch14.18-UTC
Biological: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Biological: Aldesleukin (IL-2)
Drug: Isotretinoin

First Posted Date: 2012-05-04

Last Posted Date: 2015-09-23

Lead Sponsor: United Therapeutics

Target Recruit Count: 28

Registration Number: NCT01592045

Locations: 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 10 locations

Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease

Phase 1

Terminated

Conditions: Alzheimer's Disease

Interventions: Drug: Isotretinoin

First Posted Date: 2012-03-22

Last Posted Date: 2022-06-15

Lead Sponsor: University Hospitals Cleveland Medical Center

Target Recruit Count: 3

Registration Number: NCT01560585

Locations: 🇺🇸
Parkway Medical Building, Beachwood, Ohio, United States

High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

Not Applicable

Completed

Conditions: Neuroblastoma

Interventions: Drug: Carboplatin
Biological: Autologous stem cell infusion
Biological: Granulocyte colony stimulating factor
Radiation: Radiation therapy
Drug: Isotretinoin (13-cis-retinoic acid)
Drug: Melphalan
Drug: Etoposide

First Posted Date: 2012-02-06

Last Posted Date: 2024-02-26

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 13

Registration Number: NCT01526603

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Phase 3

Completed

Conditions: Acne

Interventions: Other: vehicle gel
Drug: Epiduo/Tactuo
Drug: doxycycline 200mg
Drug: Isotretinoin

First Posted Date: 2011-11-18

Last Posted Date: 2021-02-18

Lead Sponsor: Galderma R&D

Target Recruit Count: 266

Registration Number: NCT01474590

Locations: 🇨🇦
Galderma investigational site, Woodbridge, Canada

Isotretinoin for Proliferative Vitreoretinopathy

Phase 4

Completed

Conditions: Proliferative Vitreoretinopathy

Interventions: Drug: Isotretinoin

First Posted Date: 2011-10-03

Last Posted Date: 2018-06-01

Lead Sponsor: Wills Eye

Target Recruit Count: 109

Registration Number: NCT01445028

Locations: 🇺🇸
Wills Eye Institute, Philadelphia, Pennsylvania, United States

A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory

Phase 4

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Isotretinoin

First Posted Date: 2011-07-27

Last Posted Date: 2011-07-27

Lead Sponsor: University of Aberdeen

Target Recruit Count: 18

Registration Number: NCT01404130

Locations: 🇬🇧
Anthony Ormerod, Aberdeen, Aberdeenshire, United Kingdom

Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

Phase 2

Completed

Conditions: Recurrent Neuroblastoma

Interventions: Biological: hu14.18-IL2 fusion protein
Drug: isotretinoin
Biological: sargramostim
Other: laboratory biomarker analysis

First Posted Date: 2011-04-13

Last Posted Date: 2019-10-21

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 52

Registration Number: NCT01334515

Locations: 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇺🇸
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
🇺🇸
Natalie W Bryant Cancer Center, Tulsa, Oklahoma, United States

and more 73 locations

Aflac ST1001 Prolonged Isotretinoin

Phase 1

Withdrawn

Conditions: Neuroblastoma

Interventions: Drug: Isotretinoin

First Posted Date: 2011-03-22

Last Posted Date: 2013-12-10

Lead Sponsor: Emory University

Registration Number: NCT01319838

Locations: 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma

Phase 1

Completed

Conditions: Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma

Interventions: Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vorinostat

First Posted Date: 2010-09-24

Last Posted Date: 2015-11-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 29

Registration Number: NCT01208454

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States

and more 10 locations

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

Phase 1

Active, not recruiting

Conditions: Regional Neuroblastoma
Ganglioneuroblastoma
Localized Unresectable Neuroblastoma
Stage 4 Neuroblastoma
Localized Resectable Neuroblastoma
Stage 4S Neuroblastoma

Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide Phosphate
Radiation: External Beam Radiation Therapy
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Radiation: Intensity-Modulated Radiation Therapy
Radiation: Iobenguane I-131
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Other: Pharmacological Study
Other: Questionnaire Administration
Procedure: Therapeutic Conventional Surgery
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate

First Posted Date: 2010-08-04

Last Posted Date: 2025-01-07

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 99

Registration Number: NCT01175356

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 22 locations

Drug Development Updates

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