Clinical Trials
Numerous clinical trials evaluate isotretinoin across diverse dermatological, oncological, and neurological indications, including acne vulgaris, oral leukoplakia, Alzheimer's disease, congenital ichthyosis, medulloblastoma, and neuroblastoma. Spanning Early Phase 1 through Phase 4, these studies are sponsored by academic institutions such as the Medical University of South Carolina and Assiut University, alongside pharmaceutical entities like Dr. Reddy's Laboratories and LEO Pharma. While several trials have been completed, others have been terminated, withdrawn, or remain active without recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06942039 | RECRUITING | CNS Embryonal Tumor; CNS, Medulloblastoma; Atypical Teratoid Rhabdoid Tumor; Medulloblastoma, Childhood; Medulloblastoma, Group 3; Medulloblastoma, Group 4; Pineoblastoma; Neuroblastoma; Embryonal Tumor With Multilayered Rosettes; Embryonal Tumor With Abundant Neuropil and True Rosettes; Ependymoblastoma; Medulloepithelioma; CNS Embryonal Tumor With Rhabdoid Features; CNS Embryonal Tumor, Nos |
C17 Council |
2025-09-23 | EARLY_PHASE1 |
| NCT03126916 | RECRUITING | Ganglioneuroblastoma; Ganglioneuroblastoma, Nodular; Neuroblastoma |
Children's Oncology Group |
2018-05-14 | PHASE3 |
| NCT06172296 | RECRUITING | Ganglioneuroblastoma, Nodular; Neuroblastoma |
National Cancer Institute (NCI) |
2024-04-19 | PHASE3 |
| NCT07629167 | NOT_YET_RECRUITING | Acneiform Drug Eruption; Acneiform Eruptions |
University of California, San Francisco |
2026-08-30 | PHASE2 |
| NCT06698263 | NOT_YET_RECRUITING | Men with Infertility |
University Hospital, Strasbourg, France |
2025-03-01 | PHASE4 |
| NCT07481370 | ENROLLING_BY_INVITATION | Oligospermia; Azoospermia, Nonobstructive; Infertility |
University of Nebraska |
2026-04-13 | PHASE2 |
| NCT06047535 | NOT_YET_RECRUITING | Neuroblastoma |
SciClone Pharmaceuticals |
2023-10-31 | PHASE4 |
| NCT07675239 | NOT_YET_RECRUITING | Tinea Corporis |
Pak Emirates Military Hospital |
2026-10-01 | PHASE4 |
| NCT06225570 | RECRUITING | Acne Vulgaris |
Medical University of South Carolina |
2025-02-01 | EARLY_PHASE1 |
| NCT07639073 | NOT_YET_RECRUITING | Acne Vulgaris |
Pakistan Institute of Medical Sciences |
2026-07 | PHASE4 |
| NCT07341659 | ACTIVE_NOT_RECRUITING | Acne |
Pierre Fabre Dermo Cosmetique |
2025-02-28 | |
| NCT06447480 | RECRUITING | Acne Vulgaris |
Centre Hospitalier Universitaire de Nice |
2025-04-29 | PHASE3 |
| NCT07309341 | COMPLETED | Smell Dysfunction |
Uşak University |
2025-06-01 | |
| NCT06485505 | RECRUITING | Onychomycosis |
Zagazig University |
2024-07-12 | PHASE1 |
| NCT04909515 | WITHDRAWN | Neuroblastoma |
Y-mAbs Therapeutics |
2021-12-02 | PHASE2 |
| NCT07264153 | COMPLETED | Sacroilitis |
Uşak University |
2025-11-24 | |
| NCT07196787 | RECRUITING | Isotretinoin; Isotretinoin Adverse Reaction |
Uşak University |
2025-09-30 | |
| NCT07054398 | RECRUITING | Acne Vulgaris |
Aswan University |
2025-01-10 | |
| NCT07142070 | NOT_YET_RECRUITING | Periodontal Diseases; Inflammation |
Medipol University |
2025-09-01 | |
| NCT03033303 | COMPLETED | Neuroblastoma |
Memorial Sloan Kettering Cancer Center |
2017-01-23 | PHASE2 |
| NCT07420894 | COMPLETED | Dermatophytosis; Trichophyton Infection; Resistant Dermatophyte Infection |
Multan Medical And Dental College |
2025-01-29 | |
| NCT07675460 | COMPLETED | Dry Eye; Choroidal Thickness; Retinal Vascularisation; Acne Cystic; Isotretinoin |
Demet Mutlu |
2024-04-01 | |
| NCT07012811 | COMPLETED | Plane Warts |
Latakia University |
2024-02-12 | PHASE4 |
| NCT07228481 | COMPLETED | Acne Cystic |
Premier Specialists, Australia |
2001-06-26 | PHASE4 |
| NCT06242288 | COMPLETED | Acne Vulgaris |
Mostafa Bahaa |
2024-01-30 | PHASE3 |
| NCT07753811 | COMPLETED | Dry Eye Disease (DED); Meibomian Gland Dysfunction (Disorder); Acne Vulgaris |
Benha University |
2024-01-01 | |
| NCT06225570 | Not yet recruiting | Acne Vulgaris |
Medical University of South Carolina |
2025-01 | Early Phase 1 |
| NCT05316675 | UNKNOWN | Acne Vulgaris |
Assiut University |
2022-12 | PHASE4 |
| NCT06378983 | UNKNOWN | Moderate to Severe Acne Vulgaris |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2022-09-01 | |
| NCT06873087 | COMPLETED | Rosacea |
SB Istanbul Education and Research Hospital |
2023-09-01 | PHASE4 |
| NCT06483971 | UNKNOWN | Cornea |
Superior University |
2023-11-01 | |
| NCT06250673 | COMPLETED | Acne Cystic; Diet, Healthy |
Igdir University |
2023-11-01 | |
| NCT06201624 | UNKNOWN | Melasma |
Zagazig University |
2023-03-01 | PHASE1 |
| NCT05869188 | COMPLETED | Acne Vulgaris |
South Valley University |
2023-06-01 | |
| NCT03076021 | COMPLETED | CYP2D6 Polymorphism |
University of Washington |
2016-07-26 | PHASE4 |
| NCT05666765 | UNKNOWN | Acne Vulgaris |
Tanta University |
2023-01-01 | PHASE4 |
| NCT04385277 | ACTIVE_NOT_RECRUITING | Ganglioneuroblastoma, Nodular; Neuroblastoma |
Children's Oncology Group |
2020-12-31 | PHASE2 |
| NCT01526603 | COMPLETED | Neuroblastoma |
Masonic Cancer Center, University of Minnesota |
2012-03-28 | |
| NCT04940767 | COMPLETED | Acne Vulgaris |
Edward Lain, MD |
2021-06-28 | PHASE4 |
| NCT03707236 | WITHDRAWN | Acne Vulgaris |
Massachusetts General Hospital |
2023-04-01 | |
| NCT04290572 | UNKNOWN | Flat Wart |
Centro Dermatológico Dr. Ladislao de la Pascua |
2020-03-15 | PHASE3 |
| NCT06451237 | COMPLETED | Acne Vulgaris |
Alexandria University |
2018-01-20 | PHASE3 |
| NCT05684861 | COMPLETED | Acne Vulgaris |
South Valley University |
2022-01-01 | PHASE2 |
| NCT05316675 | Not yet recruiting | Acne Vulgaris |
Assiut University |
2022-12 | Phase 4 |
| NCT04864717 | UNKNOWN | Acneiform Eruptions; Cancer, Treatment-Related |
Lady Davis Institute |
2021-09-01 | PHASE4 |
| NCT04167982 | UNKNOWN | Acne |
Shanghai Dermatology Hospital |
2020-03-28 | |
| NCT05218486 | UNKNOWN | Acne Vulgaris |
Alshimaa Abbas Mohamed Ebrahim |
2021-08-01 | PHASE4 |
| NCT03939364 | Withdrawn | Leukoplakia Oral |
Skyline Biosciences |
2022-01 | Phase 1 |
| NCT03786783 | COMPLETED | Ganglioneuroblastoma; High Risk Neuroblastoma |
National Cancer Institute (NCI) |
2019-03-04 | PHASE2 |
| NCT04594759 | COMPLETED | Acne Vulgaris |
Medical University of South Carolina |
2020-11-11 | PHASE1; PHASE2 |
| NCT05529888 | COMPLETED | Acne Vulgaris |
Aswan University |
2020-12-15 | PHASE4 |
| NCT01857934 | COMPLETED | Neuroblastoma |
St. Jude Children's Research Hospital |
2013-07-05 | PHASE2 |
| NCT04389580 | UNKNOWN | COVID-19 |
Kafrelsheikh University |
2021-09 | PHASE2 |
| NCT04353180 | UNKNOWN | COVID19 |
Kafrelsheikh University |
2021-08 | PHASE3 |
| NCT04154293 | COMPLETED | Congenital Ichthyosis |
LEO Pharma |
2019-12-03 | PHASE2 |
| NCT04361422 | UNKNOWN | COVID-19 |
Tanta University |
2020-12-01 | PHASE3 |
| NCT05218486 | Active not recruiting | Acne Vulgaris |
Alshimaa Abbas Mohamed Ebrahim|Aswan University |
2021-08-01 | Phase 4 |
| NCT04382950 | UNKNOWN | COVID |
Kafrelsheikh University |
2021-07 | PHASE1 |
| NCT05839223 | COMPLETED | Acne Vulgaris |
Jordan University of Science and Technology |
2020-09-01 | |
| NCT01701479 | UNKNOWN | Neuroblastoma |
St. Anna Kinderkrebsforschung |
2012-01 | PHASE1; PHASE2 |
| NCT04870489 | UNKNOWN | Acne Vulgaris |
Tel-Aviv Sourasky Medical Center |
2017-11-01 | PHASE2 |
| NCT04577378 | UNKNOWN | Covid19 |
Kafrelsheikh University |
2020-10-20 | PHASE2 |
| NCT04396067 | UNKNOWN | COVID-19 |
Kafrelsheikh University |
2020-10 | PHASE2 |
| NCT02795143 | WITHDRAWN | Toxic Epidermal Necrolysis |
Massachusetts General Hospital |
2016-11 | |
| NCT00867178 | COMPLETED | Medulloblastoma; Pineoblastoma; Supratentorial Embryonal Tumor, Not Otherwise Specified |
National Cancer Institute (NCI) |
2009-02-25 | PHASE1 |
| NCT02771743 | UNKNOWN | Newly Diagnosed High Risk Neuroblastoma |
Samsung Medical Center |
2015-04 | PHASE2 |
| NCT00555399 | TERMINATED | Glioblastoma Multiforme; Anaplastic Glioma |
M.D. Anderson Cancer Center |
2007-11-28 | PHASE1; PHASE2 |
| NCT03686059 | COMPLETED | Ocular Surface Disease |
Benha University |
2018-07-02 | PHASE4 |
| NCT04626817 | COMPLETED | Muscle Strength |
Cevriye Mülkoğlu |
2018-09-01 | |
| NCT04204304 | COMPLETED | Musculoskeletal Disease Other; Isotretinoin Adverse Reaction; Vitamin D Deficiency |
Ankara Training and Research Hospital |
2019-03-15 | |
| NCT00392327 | COMPLETED | Anaplastic Medulloblastoma; Medulloblastoma |
Children's Oncology Group |
2007-05-23 | PHASE3 |
| NCT03323801 | COMPLETED | Male Infertility, Azoospermia |
University of Washington |
2017-07-25 | PHASE2 |
| NCT02100930 | COMPLETED | Neuroblastoma |
Memorial Sloan Kettering Cancer Center |
2014-03 | |
| NCT03471455 | UNKNOWN | Tinea |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2018-04 | PHASE2 |
| NCT02061384 | COMPLETED | Male Infertility; Klinefelter's Syndrome; Y-chromosome Microdeletions |
University of Washington |
2014-08 | PHASE2 |
| NCT04156815 | COMPLETED | Acne Vulgaris |
xjpfW |
2018-07-05 | |
| NCT01711554 | ACTIVE_NOT_RECRUITING | Recurrent Neuroblastoma; Refractory Neuroblastoma |
National Cancer Institute (NCI) |
2013-02-04 | PHASE1 |
| NCT02457520 | COMPLETED | Acne |
Sun Pharmaceutical Industries Limited |
2015-01-21 | PHASE4 |
| NCT00334789 | COMPLETED | Adult Solid Neoplasm |
National Cancer Institute (NCI) |
2006-06-12 | PHASE1 |
| NCT02620813 | COMPLETED | Acne Vulgaris |
University of California, Davis |
2015-10 | EARLY_PHASE1 |
| NCT03514771 | COMPLETED | Acne Scars - Mixed Atrophic and Hypertrophic |
David Smart |
2016-01-28 | |
| NCT03042429 | COMPLETED | Neuroblastoma |
University of Cologne |
2007-01-01 | PHASE3 |
| NCT00526318 | UNKNOWN | Neuroblastoma |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
2007-01 | |
| NCT01175356 | COMPLETED | Ganglioneuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma |
Children's Oncology Group |
2011-12-21 | PHASE1 |
| NCT01969058 | COMPLETED | HIV-1 Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2014-07-02 | PHASE2 |
| NCT00098020 | COMPLETED | Collapsing Glomerulopathy; Glomerulosclerosis, Focal Segmental |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2004-11-26 | PHASE2 |
| NCT02752763 | COMPLETED | Dry Eye |
Niğde State Hospital |
2015-10 | PHASE4 |
| NCT02855138 | COMPLETED | Adverse Effects of Medical Drugs |
Kayseri Education and Research Hospital |
2015-01 | PHASE4 |
| NCT00567567 | COMPLETED | Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma |
Children's Oncology Group |
2007-11-05 | PHASE3 |
| NCT00112502 | COMPLETED | Brain and Central Nervous System Tumors; Glioblastoma Multiforme |
M.D. Anderson Cancer Center |
2005-09 | PHASE2 |
| NCT01208454 | COMPLETED | Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma |
National Cancer Institute (NCI) |
2010-12 | PHASE1 |
| NCT01560585 | TERMINATED | Alzheimer's Disease |
University Hospitals Cleveland Medical Center |
2012-04 | PHASE1; PHASE2 |
| NCT00499616 | COMPLETED | Neuroblastoma |
Children's Oncology Group |
2007-10-08 | PHASE3 |
| NCT01592045 | COMPLETED | Neuroblastoma |
United Therapeutics |
2012-08 | PHASE1; PHASE2 |
| NCT02278861 | COMPLETED | Actinic Keratosis |
Universidade Federal de Goias |
2011-11 | PHASE2 |
| NCT01334515 | COMPLETED | Recurrent Neuroblastoma |
Children's Oncology Group |
2011-09 | PHASE2 |
| NCT01041638 | COMPLETED | High Risk Neuroblastoma |
National Cancer Institute (NCI) |
2009-12-21 | PHASE3 |
| NCT01319838 | WITHDRAWN | Neuroblastoma |
Emory University |
2011-03 | PHASE1 |
| NCT01445028 | COMPLETED | Proliferative Vitreoretinopathy |
Wills Eye |
2011-09 | PHASE4 |
| NCT02498288 | COMPLETED | Acne Vulgaris |
GlaxoSmithKline |
2013-05-31 | PHASE1 |
| NCT01474590 | COMPLETED | Acne |
Galderma R&D |
2011-11 | PHASE3 |
| NCT01861626 | COMPLETED | Healthy Volunteers |
Pierre Fabre Dermatology |
2013-05 | PHASE1 |
| NCT01103375 | TERMINATED | Adult Anaplastic Astrocytoma; Adult Anaplastic Oligodendroglioma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Oligodendroglioma; Recurrent Adult Brain Tumor |
Wake Forest University Health Sciences |
2010-05 | PHASE1 |
| NCT01139749 | UNKNOWN | Seborrhea; Seborrheic Dermatitis; Quality of Life |
Federal University of São Paulo |
2011-10 | PHASE4 |
| NCT00026312 | COMPLETED | Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma |
National Cancer Institute (NCI) |
2001-10-26 | PHASE3 |
| NCT01863615 | COMPLETED | Skin Infections (Acne) |
GlaxoSmithKline |
2011-08-26 | PHASE1 |
| NCT01020539 | COMPLETED | Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Juvenile Myelomonocytic Leukemia |
Columbia University |
2002-09-11 | PHASE1 |
| NCT01206348 | COMPLETED | Acne |
Medicis Global Service Corporation |
2010-09 | PHASE4 |
| NCT01888224 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2011-06 | PHASE1 |
| NCT00975143 | COMPLETED | Severe Nodular Acne |
Cipher Pharmaceuticals Inc. |
2009-09 | PHASE3 |
| NCT00324740 | TERMINATED | Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer |
National Cancer Institute (NCI) |
2006-03 | PHASE1; PHASE2 |
| NCT00410631 | UNKNOWN | Neuroblastoma |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
2004-10 | PHASE3 |
| NCT00939133 | COMPLETED | Acne |
Dermatrials Research |
2009-07 | PHASE4 |
| NCT01404130 | COMPLETED | Acne Vulgaris |
University of Aberdeen |
2008-09 | PHASE4 |
| NCT00138151 | TERMINATED | Cervical Cancer |
University of Medicine and Dentistry of New Jersey |
2001-03 | PHASE2 |
| NCT00842907 | UNKNOWN | Photodamage; Photoaging |
Federal University of São Paulo |
2009-05 | PHASE2 |
| NCT00217412 | COMPLETED | Childhood Acute Promyelocytic Leukemia (M3); Childhood Atypical Teratoid/Rhabdoid Tumor; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Juvenile Myelomonocytic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Relapsing Chronic Myelogenous Leukemia; Unspecified Childhood Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2005-08 | PHASE1 |
| NCT00882531 | COMPLETED | Papular-pustular Rosacea |
Laboratoires Bailleul-Biorga |
2007-02 | PHASE3 |
| NCT00098891 | COMPLETED | Adult Grade III Lymphomatoid Granulomatosis; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2004-10 | PHASE1 |
| NCT00701740 | COMPLETED | Photoaging; Epidermal p53 Expression |
Federal University of São Paulo |
2007-07 | PHASE2 |
| NCT00004188 | COMPLETED | Neuroblastoma |
Children's Oncology Group |
2001-02 | PHASE3 |
| NCT00025038 | COMPLETED | Juvenile Myelomonocytic Leukemia |
National Cancer Institute (NCI) |
2001-06 | PHASE2 |
| NCT00176527 | TERMINATED | Prostate Cancer |
University of Medicine and Dentistry of New Jersey |
2002-11 | PHASE2 |
| NCT00040872 | COMPLETED | Neuroblastoma |
Memorial Sloan Kettering Cancer Center |
2000-06 | PHASE2 |
| NCT00089258 | COMPLETED | Neuroblastoma |
Memorial Sloan Kettering Cancer Center |
2004-07 | PHASE2 |
| NCT00070200 | COMPLETED | Neuroblastoma |
Children's Oncology Group |
2004-03 | PHASE1 |
| NCT00078988 | COMPLETED | Brain Tumor; Central Nervous System Tumor |
Children's Oncology Group |
2004-10 | PHASE3 |
| NCT00017368 | COMPLETED | Neuroblastoma |
Children's Oncology Group |
2001-04 | PHASE2 |
| NCT00038376 | COMPLETED | Lymphoma, T-Cell; Mycosis Fungoides; Hematologic Neoplasms |
M.D. Anderson Cancer Center |
1990-05-08 | PHASE2 |
| NCT00054561 | COMPLETED | Head and Neck Cancer |
Eastern Cooperative Oncology Group |
2003-11-26 | PHASE3 |
| NCT00004110 | COMPLETED | Neuroblastoma |
Memorial Sloan Kettering Cancer Center |
1999-08 | PHASE2 |
| NCT00005847 | COMPLETED | Prostate Cancer |
Eastern Cooperative Oncology Group |
2001-04-05 | PHASE2 |
| NCT01888341 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2002-08 | PHASE1 |
| NCT00005576 | COMPLETED | Disseminated Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma |
National Cancer Institute (NCI) |
2001-01 | PHASE1 |
| NCT01888289 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2001-07 | PHASE1 |
| NCT00003585 | COMPLETED | Kidney Cancer |
University of New Mexico |
1996-08 | PHASE1; PHASE2 |
| NCT01888328 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2001-05 | PHASE1 |
| NCT00002737 | COMPLETED | Kidney Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
1996-03 | PHASE3 |
| NCT00021359 | COMPLETED | Multiple Myeloma and Plasma Cell Neoplasm |
Fox Chase Cancer Center |
1999-08 | PHASE2 |
| NCT00003405 | WITHDRAWN | Leukemia |
Rush University Medical Center |
1998-04 | PHASE2 |
| NCT00002506 | COMPLETED | Cervical Cancer; Esophageal Cancer; Head and Neck Cancer; Lung Cancer; Non-melanomatous Skin Cancer; Penile Cancer |
Hoag Memorial Hospital Presbyterian |
1992-08 | PHASE2 |
| NCT00030719 | UNKNOWN | Neuroblastoma |
University of Leicester |
2001-12 | PHASE3 |
| NCT00025012 | COMPLETED | Melanoma (Skin); Non-melanomatous Skin Cancer |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
1991-06 | |
| NCT00416585 | COMPLETED | Acne |
Shahid Beheshti University of Medical Sciences |
2005-10 | PHASE1 |
| NCT00003564 | WITHDRAWN | Brain and Central Nervous System Tumors |
M.D. Anderson Cancer Center |
PHASE3 | |
| NCT00003599 | WITHDRAWN | Lung Cancer |
M.D. Anderson Cancer Center |
PHASE3 | |
| NCT00003619 | COMPLETED | Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Thrombocytopenia |
Drexel University College of Medicine |
1998-02 | PHASE1; PHASE2 |
| NCT00939965 | UNKNOWN | Neuroblastoma |
Children's Cancer and Leukaemia Group |
2009-02 | |
| NCT00014729 | COMPLETED | Epidermolysis Bullosa |
University of North Carolina |
2000-10 | PHASE1 |
| NCT00000764 | COMPLETED | HIV Infections; Anus Neoplasms |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00001073 | COMPLETED | HIV Infections; Cervix, Dysplasia |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-07-14)
Check the
Isotretinoin (13-cis retinoic acid)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Jump to
- Isotretinoin (13-cis retinoic acid) Solubility in DMSO
- Isotretinoin (13-cis retinoic acid) Stock Solution
- Isotretinoin (13-cis retinoic acid) Storage
- Isotretinoin (13-cis retinoic acid) Stability
- Isotretinoin (13-cis retinoic acid) Molecular Weight
- Isotretinoin (13-cis retinoic acid) SMILES
- Isotretinoin (13-cis retinoic acid) CAS Number
- Isotretinoin (13-cis retinoic acid) Chemical Structure (2D and 3D)
- Isotretinoin (13-cis retinoic acid) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.