MedPath

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

Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

Early Phase 1
Not yet recruiting
Conditions
CNS Embryonal Tumor
CNS, Medulloblastoma
Atypical Teratoid Rhabdoid Tumor
Medulloblastoma, Childhood
Medulloblastoma, Group 3
Medulloblastoma, Group 4
Pineoblastoma
Embryonal Tumor With Abundant Neuropil and True Rosettes
Ependymoblastoma
Medulloepithelioma
Interventions
Drug: Topotecan IT
First Posted Date
2025-04-24
Last Posted Date
2025-04-24
Lead Sponsor
C17 Council
Target Recruit Count
15
Registration Number
NCT06942039

Changes in PACAP, CGRP, and VIP Levels in Rosacea Patients on Systemic Isotretinoin and Their Association with Erythema

Phase 4
Completed
Conditions
Rosacea
Interventions
First Posted Date
2025-03-12
Last Posted Date
2025-03-12
Lead Sponsor
SB Istanbul Education and Research Hospital
Target Recruit Count
30
Registration Number
NCT06873087
Locations
🇹🇷

Istanbul Training and Research Hospital, Istanbul, Fatih, Turkey

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

Phase 4
Not yet recruiting
Conditions
Men with Infertility
Interventions
Drug: Control group (placebo)
First Posted Date
2024-11-20
Last Posted Date
2024-11-25
Lead Sponsor
University Hospital, Strasbourg, France
Target Recruit Count
100
Registration Number
NCT06698263
Locations
🇫🇷

CECOS Alsace Strasbourg, Schiltigheim, France

Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

Phase 1
Not yet recruiting
Conditions
Onychomycosis
Interventions
Device: excimer light
First Posted Date
2024-07-03
Last Posted Date
2024-07-03
Lead Sponsor
Zagazig University
Target Recruit Count
36
Registration Number
NCT06485505

Acne Remission Maintenance by Weekend Systemic Isotretinoin

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2024-06-11
Last Posted Date
2024-06-11
Lead Sponsor
Alexandria University
Target Recruit Count
60
Registration Number
NCT06451237
Locations
🇪🇬

Alexandria University, Alexandria, Egypt

Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

Phase 3
Recruiting
Conditions
Acne Vulgaris
Interventions
Drug: Topical cream
First Posted Date
2024-06-07
Last Posted Date
2025-03-25
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
420
Registration Number
NCT06447480
Locations
🇬🇫

CH de Cayenne 3 Avenue Alexis Blaise, BP6006, Cayenne, French Guiana

🇫🇷

CHU de Nice - Hôpital de l'Archet, Nice, Alpes-Maritimes, France

🇫🇷

CHU de Bordeaux, Bordeaux, Aquitaine, France

and more 13 locations

Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne

Not Applicable
Recruiting
Conditions
Moderate to Severe Acne Vulgaris
Interventions
Other: Oral isotretinoin combined with microneedle radiofrequency therapy
First Posted Date
2024-04-23
Last Posted Date
2024-04-23
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
100
Registration Number
NCT06378983
Locations
🇨🇳

Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University., Guangzhou, China

Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2024-02-05
Last Posted Date
2025-03-04
Lead Sponsor
Mostafa Bahaa
Target Recruit Count
40
Registration Number
NCT06242288
Locations
🇪🇬

Tanta Unuversity, Tanta, Egypt

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Early Phase 1
Recruiting
Conditions
Acne Vulgaris
Interventions
First Posted Date
2024-01-26
Last Posted Date
2025-04-08
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
50
Registration Number
NCT06225570
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

Oral Isotretinoin in Melasma a Randomized Controlled Trial

Phase 1
Recruiting
Conditions
Melasma
Interventions
Drug: Triple combination formula
First Posted Date
2024-01-11
Last Posted Date
2024-01-11
Lead Sponsor
Zagazig University
Target Recruit Count
40
Registration Number
NCT06201624
Locations
🇪🇬

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University, Zagazig, Select Region, Egypt

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy