Clinical Trials
Tazarotene has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4 to assess its efficacy in dermatological conditions, primarily plaque psoriasis, scalp psoriasis, and acne vulgaris, alongside secondary indications like atrophic post-acne scarring and lentigo maligna. Sponsored by academic research centers and pharmaceutical entities such as Bausch Health, Valeant, Stiefel, and Dr. Reddy's Laboratories, the majority of these studies are completed. Nevertheless, ongoing trials actively recruit participants to evaluate novel topical formulations and therapeutic protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06331624 | COMPLETED | Idiopathic Pulmonary Fibrosis; IPF |
GRI Bio Operations, Inc. |
2024-04-24 | PHASE2 |
| NCT06042647 | COMPLETED | Psoriasis Vulgaris |
Dermatology Consulting Services, PLLC |
2023-07-13 | PHASE4 |
| NCT05872256 | COMPLETED | Scalp Psoriasis |
Dermatology Consulting Services, PLLC |
2023-06-01 | PHASE4 |
| NCT05555797 | UNKNOWN | Psoriasis |
Assiut University |
2022-10-30 | PHASE4 |
| NCT06015152 | COMPLETED | Scalp Psoriasis |
Jinnah Postgraduate Medical Centre |
2022-08-01 | |
| NCT05314127 | UNKNOWN | Warts Flat |
Zagazig University |
2022-04-15 | PHASE2 |
| NCT06015152 | Completed | Scalp Psoriasis |
Jinnah Postgraduate Medical Centre |
2022-08-01 | Not Applicable |
| NCT04720105 | COMPLETED | Palmoplantar Psoriasis; Plaque Psoriasis |
Icahn School of Medicine at Mount Sinai |
2020-11-19 | PHASE4 |
| NCT05282771 | COMPLETED | Plaque Psoriasis |
Sun Pharmaceutical Industries, Inc. |
2021-04-16 | EARLY_PHASE1 |
| NCT05704114 | COMPLETED | Acne Vulgaris; Post Inflammatory Hyperpigmentation; Post Inflammatory Pigmentation Change; Erythema; Skin Scarring |
Dr. Emmy Graber |
2021-02-01 | PHASE4 |
| NCT04071756 | TERMINATED | Solid Tumor; Hand-Foot Skin Reaction (HFSR) |
Dana-Farber Cancer Institute |
2019-12-30 | PHASE2 |
| NCT03988439 | Recruiting | Psoriasis |
Bausch Health Americas Inc. |
2021-03-24 | Phase 4 |
| NCT05573425 | COMPLETED | Acne Scar |
Jinnah Postgraduate Medical Centre |
2020-08-22 | PHASE2; PHASE3 |
| NCT03263624 | UNKNOWN | Nail Psoriasis |
Assiut University |
2017-10-01 | PHASE4 |
| NCT03341910 | COMPLETED | Acne Vulgaris |
Dr. Reddy's Laboratories Limited |
2017-08-21 | PHASE2 |
| NCT03292640 | COMPLETED | Acne Vulgaris |
Dr. Reddy's Laboratories Limited |
2017-07-06 | PHASE3 |
| NCT03599193 | COMPLETED | Acne Vulgaris |
Dr. Reddy's Laboratories Limited |
2017-10-04 | PHASE2 |
| NCT03170596 | COMPLETED | Atrophic Post Acne Scarring |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2017-06-02 | |
| NCT02886702 | COMPLETED | Plaque Psoriasis |
Fougera Pharmaceuticals Inc. |
2016-09-19 | PHASE3 |
| NCT02886715 | COMPLETED | Acne Vulgaris |
Fougera Pharmaceuticals Inc. |
2016-09-21 | PHASE3 |
| NCT02721173 | COMPLETED | Acne Vulgaris |
All India Institute of Medical Sciences, Bhubaneswar |
2016-04 | PHASE4 |
| NCT02785159 | COMPLETED | Psoriasis |
Bausch Health Americas, Inc. |
2016-02 | PHASE2 |
| NCT02938494 | COMPLETED | Acne Vulgaris |
Bausch Health Americas, Inc. |
2015-11 | PHASE2 |
| NCT02525822 | UNKNOWN | Acne Vulgaris |
Valeant Pharmaceuticals |
2015-09 | PHASE2 |
| NCT02160665 | COMPLETED | Plaque Psoriasis |
G & W Laboratories Inc. |
2014-05 | PHASE3 |
| NCT02620813 | Completed | Acne Vulgaris |
University of California Davis |
2015-10 | Early Phase 1 |
| NCT02160678 | COMPLETED | Acne Vulgaris |
G & W Laboratories Inc. |
2014-05 | PHASE3 |
| NCT02218034 | COMPLETED | Acne Vulgaris |
Allergan |
2014-08 | PHASE1 |
| NCT02411955 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2014-06 | PHASE1 |
| NCT02267746 | COMPLETED | Acne Vulgaris |
Actavis Inc. |
2014-06 | PHASE3 |
| NCT02235480 | COMPLETED | Nail Psoriasis |
Almirall, S.A. |
2014-02 | PHASE2 |
| NCT01616654 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2012-06-20 | PHASE2 |
| NCT00707174 | COMPLETED | Cancer; Lentigo Maligna |
University of Utah |
2005-03 | |
| NCT00489086 | COMPLETED | Neoplastic Syndrome |
UCSF Benioff Children's Hospital Oakland |
2004-07 | PHASE2 |
| NCT00783965 | COMPLETED | Skin Carcinoma |
UCSF Benioff Children's Hospital Oakland |
2004-07 | PHASE2 |
| NCT00779896 | UNKNOWN | Cutaneous T-Cell Lymphoma |
McGill University |
2008-10 | PHASE1; PHASE2 |
| NCT01094717 | TERMINATED | Psoriasis |
University of Utah |
2010-01 | |
| NCT00667589 | TERMINATED | Hand-foot Skin Reaction; Rash |
Northwestern University |
2008-06 | PHASE2 |
| NCT01017120 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-10-01 | PHASE3 |
| NCT01017146 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-10 | PHASE3 |
| NCT01114841 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2010-03-31 | PHASE1 |
| NCT01119651 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2010-06-14 | PHASE1 |
| NCT01112787 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2010-03-26 | PHASE1 |
| NCT01115322 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2010-04-01 | PHASE1 |
| NCT01016977 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-10 | PHASE4 |
| NCT01019603 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-10-12 | PHASE1 |
| NCT00834210 | COMPLETED | Acne Vulgaris |
Allergan |
2008-12 | PHASE4 |
| NCT00713609 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2008-06 | PHASE2 |
| NCT00829049 | TERMINATED | Acne Vulgaris |
Allergan |
2007-10 | PHASE4 |
| NCT00648986 | COMPLETED | Brittle Nails |
Columbia University |
2005-08 | PHASE4 |
| NCT00469755 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2006-02 | PHASE4 |
| NCT00145106 | COMPLETED | Acne Vulgaris |
KGL, Inc. |
2002-03 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-10-30)
Check the
Tazarotene
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>).
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Note: Technical data last updated: Sep 1, 2026.