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

Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin

Not Applicable

Completed

Conditions: Musculoskeletal Disease Other
Isotretinoin Adverse Reaction
Vitamin D Deficiency

Interventions: Drug: Isotretinoin

First Posted Date: 2019-12-18

Last Posted Date: 2019-12-18

Lead Sponsor: Ankara Training and Research Hospital

Target Recruit Count: 177

Registration Number: NCT04204304

Locations: 🇹🇷
Ankara Training and Research Hospital, Ankara, Turkey

Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris

Not Applicable

Conditions: Acne

Interventions: Procedure: Aminolevulinic acid photodynamic therapy
Drug: Oral conventional-dose isotretinoin
Drug: Oral low-dose isotretinoin

First Posted Date: 2019-11-19

Last Posted Date: 2020-11-24

Lead Sponsor: Shanghai Dermatology Hospital

Target Recruit Count: 234

Registration Number: NCT04167982

Locations: 🇨🇳
Lei Shi, Shanghai, Shanghai, China

Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy

Not Applicable

Completed

Conditions: Acne Vulgaris

Interventions: Radiation: 1,565nm NAFL
Drug: Oral isotretinoin
Other: Pricking blood therapy

First Posted Date: 2019-11-08

Last Posted Date: 2019-11-08

Lead Sponsor: xjpfW

Target Recruit Count: 60

Registration Number: NCT04156815

Locations: 🇨🇳
Dermatology Derpartment of Xijing Hospital, Xi'an, Shaanxi, China

A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis

Phase 2

Completed

Conditions: Congenital Ichthyosis

Interventions: Other: Vehicle
Drug: Isotretinoin

First Posted Date: 2019-11-06

Last Posted Date: 2022-08-25

Lead Sponsor: Timber Pharmaceuticals Inc.

Target Recruit Count: 34

Registration Number: NCT04154293

Locations: 🇺🇸
Minnesota Clinical Study Center, New Brighton, Minnesota, United States
🇺🇸
Yale Center for Clinical Investigation, New Haven, Connecticut, United States
🇺🇸
Austin Institute for Clinical Research, Inc, Metairie, Louisiana, United States

and more 8 locations

This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions

Phase 1

Withdrawn

Conditions: Leukoplakia, Oral

Interventions: Drug: SBS-101
Drug: Placebo

First Posted Date: 2019-05-06

Last Posted Date: 2021-10-19

Lead Sponsor: Skyline Biosciences

Registration Number: NCT03939364

Locations: 🇺🇸
PennState Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
🇺🇸
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC), Birmingham, Alabama, United States
🇺🇸
Carolinas Center for Oral Health, Charlotte, North Carolina, United States

and more 2 locations

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Phase 2

Active, not recruiting

Conditions: Ganglioneuroblastoma
High Risk Neuroblastoma

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Dexrazoxane
Biological: Dinutuximab
Drug: Doxorubicin
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Drug: Isotretinoin
Drug: Melphalan
Biological: Sargramostim
Drug: Thiotepa
Drug: Topotecan
Drug: Vincristine

First Posted Date: 2018-12-26

Last Posted Date: 2025-03-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT03786783

Locations: 🇺🇸
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
🇳🇿
Starship Children's Hospital, Grafton, Auckland, New Zealand
🇦🇺
The Children's Hospital at Westmead, Westmead, New South Wales, Australia

and more 7 locations

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

Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin

Not Applicable

Completed

Conditions: Acne Scars - Mixed Atrophic and Hypertrophic

Interventions: Device: Fraxel DUAL 1550/1927
Drug: oral isotretinoin
Drug: oral valacyclovir

First Posted Date: 2018-05-02

Last Posted Date: 2018-05-02

Lead Sponsor: David Smart

Target Recruit Count: 15

Registration Number: NCT03514771

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

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Drug: Carboplatin
Drug: Busulfan
Drug: Cisplatin
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Dexrazoxane Hydrochloride
Biological: Dinutuximab
Drug: Doxorubicin Hydrochloride
Procedure: Echocardiography
Drug: Etoposide Phosphate
Radiation: External Beam Radiation Therapy
Radiation: Iobenguane I-123
Drug: Isotretinoin
Radiation: Iobenguane I-131
Procedure: Multigated Acquisition Scan
Drug: Lorlatinib
Drug: Melphalan Hydrochloride
Procedure: Positron Emission Tomography
Procedure: Magnetic Resonance Imaging
Biological: Sargramostim
Procedure: Therapeutic Conventional Surgery
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate

First Posted Date: 2017-04-25

Last Posted Date: 2025-03-19

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 724

Registration Number: NCT03126916

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Phoenix Childrens Hospital, Phoenix, Arizona, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States

and more 158 locations

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