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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

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Phase 3
Recruiting
Conditions
Ganglioneuroblastoma, Nodular
Neuroblastoma
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan
Procedure: Hematopoietic Cell Transplantation
Procedure: Leukapheresis
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Radiation: Radiation Therapy
Procedure: Radionuclide Imaging
Other: Survey Administration
Procedure: Tumor Resection
First Posted Date
2023-12-15
Last Posted Date
2025-05-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
478
Registration Number
NCT06172296
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

USA Health Strada Patient Care Center, Mobile, Alabama, United States

🇺🇸

Banner Children's at Desert, Mesa, Arizona, United States

and more 150 locations

The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris

Recruiting
Conditions
Acne Vulgaris
Interventions
Diagnostic Test: Hormone
First Posted Date
2023-06-15
Last Posted Date
2023-06-15
Lead Sponsor
Marmara University
Target Recruit Count
40
Registration Number
NCT05903716
Locations
🇹🇷

Marmara University School of Medicine,Department of Dermatology., Istanbul, Turkey

Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

Not Applicable
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2023-05-22
Last Posted Date
2024-12-09
Lead Sponsor
South Valley University
Target Recruit Count
60
Registration Number
NCT05869188
Locations
🇪🇬

Qena Hospital, Qinā, Egypt

Serum TWEAK Levels in Acne Vulgaris

Phase 2
Completed
Conditions
Acne Vulgaris
Interventions
Diagnostic Test: ELISA Assays of Serum TWEAK.
First Posted Date
2023-01-13
Last Posted Date
2023-01-13
Lead Sponsor
South Valley University
Target Recruit Count
150
Registration Number
NCT05684861
Locations
🇪🇬

South Valley University, Qinā, Qena, Egypt

Comparison Between Isotretinoin, Silymarin and Both in the Treatment of Acne Vulgaris

Phase 4
Not yet recruiting
Conditions
Acne Vulgaris
Interventions
First Posted Date
2022-12-28
Last Posted Date
2022-12-28
Lead Sponsor
Tanta University
Target Recruit Count
75
Registration Number
NCT05666765
Locations
🇪🇬

Tanta University, Tanta, Egypt

Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2022-09-07
Last Posted Date
2022-09-07
Lead Sponsor
Aswan University
Target Recruit Count
60
Registration Number
NCT05529888
Locations
🇪🇬

Aswan University-Faculty of Medicine, Aswan, New Aswan City, Egypt

Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar

Completed
Conditions
Isotretinoin
Acne Vulgaris
Atrophic Acne Scar
Interventions
First Posted Date
2022-06-09
Last Posted Date
2022-06-09
Lead Sponsor
Istanbul Training and Research Hospital
Target Recruit Count
30
Registration Number
NCT05413200
Locations
🇹🇷

Istanbul Training and Research Hospital, Istanbul, Turkey

Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma

Phase 1
Completed
Conditions
High-risk Neuroblastoma
Interventions
First Posted Date
2022-05-13
Last Posted Date
2024-10-04
Lead Sponsor
BeiGene
Target Recruit Count
8
Registration Number
NCT05373901
Locations
🇨🇳

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, Shanghai, China

🇨🇳

Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China

🇨🇳

The Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Impact of Isotretinoin in Different Doses on Quality of Life

Phase 4
Not yet recruiting
Conditions
Acne Vulgaris
Interventions
First Posted Date
2022-04-07
Last Posted Date
2022-04-07
Lead Sponsor
Assiut University
Target Recruit Count
100
Registration Number
NCT05316675

The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis

Phase 3
Completed
Conditions
Ichthyosis
Interventions
Drug: Matching Vehicle
First Posted Date
2022-03-25
Last Posted Date
2025-02-25
Lead Sponsor
Timber Pharmaceuticals Inc.
Target Recruit Count
209
Registration Number
NCT05295732
Locations
🇺🇸

University of Miami, Dermatology Clinical Trial Unit, Miami, Florida, United States

🇺🇸

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States

🇫🇷

Hopital Necker APHP, Paris, France

and more 30 locations
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