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-cont...

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

Associated Therapies: -

Clinical Trials

Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: Cabozantinib
Drug: 13-cis-retinoic acid

First Posted Date: 2018-08-02

Last Posted Date: 2024-08-05

Lead Sponsor: Peter Zage

Target Recruit Count: 18

Registration Number: NCT03611595

Locations: 🇺🇸
Rady Children's Hospital - San Diego, San Diego, California, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

Phase 2

Conditions: Tinea

Interventions: Drug: Itraconazole 200 mg
Drug: Terbinafine
Drug: Isotretinoin

First Posted Date: 2018-03-20

Last Posted Date: 2018-05-01

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 100

Registration Number: NCT03471455

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Phase 3

Active, not recruiting

Conditions: Ganglioneuroblastoma
Neuroblastoma

First Posted Date: 2017-04-25

Last Posted Date: 2024-12-04

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 724

Registration Number: NCT03126916

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 158 locations

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: 2023-11-30

Lead Sponsor: University of Washington

Target Recruit Count: 36

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

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

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

Drug Development Updates

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