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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

Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

Phase 1
Completed
Conditions
HIV Infections
Anus Neoplasms
First Posted Date
2001-08-31
Last Posted Date
2021-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
98
Registration Number
NCT00000764
Locations
🇺🇸

University of Washington AIDS CRS, Seattle, Washington, United States

Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

Phase 1
Completed
Conditions
Epidermolysis Bullosa
First Posted Date
2001-04-11
Last Posted Date
2015-03-25
Lead Sponsor
University of North Carolina
Target Recruit Count
20
Registration Number
NCT00014729
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