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

Effects of Isotretinoin on CYP2D6 Activity

Phase 4

Completed

Conditions: CYP2D6 Polymorphism

Interventions: Drug: Isotretinoin
Drug: dextromethorphan

First Posted Date: 2017-03-09

Last Posted Date: 2025-01-28

Lead Sponsor: University of Washington

Target Recruit Count: 33

Registration Number: NCT03076021

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

Phase 2

Active, not recruiting

Conditions: Neuroblastoma

Interventions: Biological: Hu3F8
Drug: GM-CSF
Drug: Isotretinoin

First Posted Date: 2017-01-26

Last Posted Date: 2024-07-03

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 59

Registration Number: NCT03033303

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Effects of Isotretinoin on The Gonads and Hirsutism

Phase 4

Completed

Conditions: Adverse Effects of Medical Drugs

Interventions: Drug: oral isotretinoin

First Posted Date: 2016-08-04

Last Posted Date: 2016-08-05

Lead Sponsor: Kayseri Education and Research Hospital

Target Recruit Count: 80

Registration Number: NCT02855138

Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study

Not Applicable

Withdrawn

Conditions: Toxic Epidermal Necrolysis

Interventions: Drug: Isotretinoin
Other: Placebo

First Posted Date: 2016-06-09

Last Posted Date: 2023-06-07

Lead Sponsor: Massachusetts General Hospital

Registration Number: NCT02795143

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Response-based Treatment of High-risk Neuroblastoma

Phase 2

Conditions: Newly Diagnosed High Risk Neuroblastoma

Interventions: Drug: Cisplatin
Drug: Doxorubicin
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Ifosfamide
Drug: Carboplatin
Procedure: Tandem HDCT/auto-SCT
Radiation: Radiotherapy
Drug: Interleukin-2
Drug: Isotretinoin
Radiation: MIBG

First Posted Date: 2016-05-13

Last Posted Date: 2016-05-24

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 54

Registration Number: NCT02771743

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

De Novo Lipogenesis of Sebaceous Glands in Acne

Early Phase 1

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Isotretinoin
Drug: Tretinoin

First Posted Date: 2015-12-03

Last Posted Date: 2021-08-05

Lead Sponsor: University of California, Davis

Target Recruit Count: 32

Registration Number: NCT02620813

Locations: 🇺🇸
Dermatology Research Area, Davis, California, United States
🇺🇸
UC Davis Department of Dermatology, Sacramento, California, United States

ABSORICA in Patients With Severe Recalcitrant Nodular Acne

Phase 4

Completed

Conditions: Acne

Interventions: Drug: Isotretinoin

First Posted Date: 2015-05-29

Last Posted Date: 2021-04-27

Lead Sponsor: Sun Pharmaceutical Industries Limited

Target Recruit Count: 201

Registration Number: NCT02457520

Locations: 🇺🇸
Texas Dermatology and Laser Specialists, San Antonio, Texas, United States

Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

Phase 2

Completed

Conditions: Actinic Keratosis

Interventions: Drug: Tretinoin 0,05% cream
Drug: Oral isotretinoin
Drug: Sunscreen FPS 60

First Posted Date: 2014-10-30

Last Posted Date: 2014-10-30

Lead Sponsor: Universidade Federal de Goias

Target Recruit Count: 60

Registration Number: NCT02278861

Locations: 🇧🇷
Dermatology Outpatient Clinic - Hospital das Clínicas - Federal University of Goias (UFG), Goiânia, Goiás, Brazil

The Lipid Profile of the Skin Surface in Acne

Completed

Conditions: Acne

Interventions: Drug: Tretinoin or Adapalene
Drug: Isotretinoin

First Posted Date: 2014-07-02

Last Posted Date: 2017-05-30

Lead Sponsor: University of California, Davis

Target Recruit Count: 30

Registration Number: NCT02180425

Locations: 🇺🇸
UC Davis Department of Dermatology, Sacramento, California, United States
🇺🇸
Dermatology Research Area, Davis, California, United States

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Not Applicable

Completed

Conditions: Neuroblastoma

Interventions: Biological: Anti-GD2 3F8 Monoclonal Antibody
Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor)
Drug: oral isotretinoin

First Posted Date: 2014-04-01

Last Posted Date: 2020-02-28

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 69

Registration Number: NCT02100930

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

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