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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

Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients

Phase 4
Active, not recruiting
Conditions
Acne Vulgaris
Interventions
First Posted Date
2022-02-01
Last Posted Date
2022-09-06
Lead Sponsor
Alshimaa Abbas Mohamed Ebrahim
Target Recruit Count
60
Registration Number
NCT05218486
Locations
🇪🇬

Aswan university, Aswan, Egypt

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2021-06-28
Last Posted Date
2023-06-22
Lead Sponsor
Edward Lain, MD
Target Recruit Count
31
Registration Number
NCT04940767
Locations
🇺🇸

Austin Institute for Clinical Research, Inc., Pflugerville, Texas, United States

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Phase 2
Withdrawn
Conditions
Neuroblastoma
Interventions
First Posted Date
2021-06-01
Last Posted Date
2022-09-01
Lead Sponsor
Y-mAbs Therapeutics
Registration Number
NCT04909515
Locations
🇷🇺

National Medical Research Center Pediatric Hematology, Oncology and Immunology n.a Dmitry Rogachev, Moscow, Russian Federation

🇸🇬

ICON Cancer Centre Novena, Singapore, Singapore

🇷🇺

Research Institute of Pediatric Oncology ad Hematology of N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation

and more 6 locations

Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI

Phase 4
Conditions
Cancer, Treatment-Related
Acneiform Eruptions
Interventions
First Posted Date
2021-04-29
Last Posted Date
2021-09-08
Lead Sponsor
Lady Davis Institute
Target Recruit Count
98
Registration Number
NCT04864717
Locations
🇨🇦

Jewish General Hospital, Montreal, Quebec, Canada

Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate

Completed
Conditions
Nail Abnormality
Isotretinoin
Interventions
First Posted Date
2020-12-09
Last Posted Date
2020-12-09
Lead Sponsor
Sinan Özçelik
Target Recruit Count
70
Registration Number
NCT04660916
Locations
🇹🇷

Balikesir University, Balıkesir, Turkey

Weekly Isotretinoin Therapy Study

Phase 1
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2020-10-20
Last Posted Date
2022-05-09
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
22
Registration Number
NCT04594759
Locations
🇺🇸

Samantha Karline, Charleston, South Carolina, United States

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Phase 2
Active, not recruiting
Conditions
Ganglioneuroblastoma, Nodular
Neuroblastoma
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: FDG-Positron Emission Tomography
Radiation: Iobenguane I-123
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
First Posted Date
2020-05-12
Last Posted Date
2024-10-22
Lead Sponsor
Children's Oncology Group
Target Recruit Count
41
Registration Number
NCT04385277
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

and more 74 locations

Isotretinoin in Treatment of COVID-19

Phase 3
Conditions
COVID-19
Interventions
First Posted Date
2020-04-24
Last Posted Date
2020-09-23
Lead Sponsor
Tanta University
Target Recruit Count
300
Registration Number
NCT04361422

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized)

Phase 3
Conditions
COVID19
Interventions
Drug: Aerosolized 13 cis retinoic acid
Drug: Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment
Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment
Drug: Standard treatment
First Posted Date
2020-04-20
Last Posted Date
2021-08-05
Lead Sponsor
Kafrelsheikh University
Target Recruit Count
100000
Registration Number
NCT04353180
Locations
🇪🇬

Faculty of Medicine, Kafr El-sheikh University, Cairo, Egypt

Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts

Phase 3
Conditions
Flat Wart
Interventions
First Posted Date
2020-03-02
Last Posted Date
2020-03-03
Lead Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Target Recruit Count
162
Registration Number
NCT04290572
Locations
🇲🇽

Centro Dermatológico "Dr. Ladislao de la Pascua", Mexico City, Mexico

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