Numerous clinical trials spanning all phases evaluate the therapeutic utility and safety of acitretin across conditions such as plaque psoriasis, pustular palmoplantar psoriasis, chronic hand dermatitis, primary cutaneous amyloidosis, and non-melanomatous skin cancers. Sponsored by academic medical centers, university hospitals, and specialized dermatological research organizations, these studies investigate dosing and combination regimens involving phototherapy or biologic agents. Recruitment statuses across these trials encompass completed, actively recruiting, withdrawn, and unknown categories.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04537689 | RECRUITING | Plaque Psoriasis |
Singapore General Hospital |
2020-12-10 | PHASE4 |
| NCT04239859 | NOT_YET_RECRUITING | Plaque Psoriasis |
Singapore General Hospital |
2024-01 | PHASE4 |
| NCT06998875 | RECRUITING | Primary Cutaneous Amyloidosis |
Army Medical University, China |
2025-03-01 | PHASE4 |
| NCT07708480 | COMPLETED | Hidradenitis Suppurativa |
Hayat Abad Medical Complex, Peshawar |
2024-12-22 | PHASE4 |
| NCT06739551 | NOT_YET_RECRUITING | Lichen Planus |
Sheikh Zayed Medical College |
2024-12-10 | PHASE2 |
| NCT05184348 | COMPLETED | Psoriasis Vulgaris |
South Valley University |
2021-09-01 | PHASE1 |
| NCT05401006 | UNKNOWN | Psoriasis |
South Valley University |
2021-06-05 | PHASE4 |
| NCT04245319 | UNKNOWN | Hyperlipidemias; Xerosis; Depression; Liver Diseases |
Cairo University |
2020-01-01 | |
| NCT04841187 | Completed | Psoriasis |
Assistance Publique - Hôpitaux de Paris|Société de Dermatologie Française |
2021-09-06 | -- |
| NCT05203354 | COMPLETED | Psoriasis |
Mahmoud Ahmed Ali Ahmed |
2018-09-01 | PHASE4 |
| NCT04245319 | Unknown status | Hyperlipidemias|Xerosis|Depression|Liver Diseases |
Cairo University |
2020-01-01 | Not Applicable |
| NCT03753867 | WITHDRAWN | HIV Infections |
Ottawa Hospital Research Institute |
2019-01-07 | PHASE1 |
| NCT05203354 | Completed | Psoriasis |
Mahmoud Ahmed Ali Ahmed|Aswan University Hospital |
2018-09-01 | Phase 4 |
| NCT02715960 | UNKNOWN | Psoriasis Vulgaris |
Central South University |
2015-12 | PHASE2 |
| NCT00488384 | WITHDRAWN | Carcinoma, Squamous Cell |
Günther Hofbauer |
2007-06 | PHASE4 |
| NCT02050321 | TERMINATED | Malignant Melanoma |
University of Arizona |
2013-12 | PHASE2 |
| NCT02181790 | TERMINATED | Psoriasis, Skin or Nails |
Icahn School of Medicine at Mount Sinai |
2014-06 | PHASE4 |
| NCT01545284 | COMPLETED | Chronic Hand Dermatitis |
Innovaderm Research Inc. |
2012-03 | PHASE2; PHASE3 |
| NCT02191020 | COMPLETED | Psoriasis |
Xijing Hospital |
2013-02 | |
| NCT01078168 | COMPLETED | Alzheimer Disease |
K. Lieb |
2010-03 | PHASE2 |
| NCT01443338 | UNKNOWN | Psoriasis Vulgaris |
Ministry of Health, China |
2011-09 | PHASE4 |
| NCT01228409 | UNKNOWN | Psoriasis |
Frankel, Amylynne, M.D. |
2010-10 | PHASE4 |
| NCT01299220 | WITHDRAWN | Skin Rash |
University of Pittsburgh |
2010-11 | PHASE4 |
| NCT01094717 | TERMINATED | Psoriasis |
University of Utah |
2010-01 | |
| NCT00936065 | COMPLETED | Moderate to Severe Psoriasis |
Pfizer |
2009-07 | PHASE4 |
| NCT00832364 | WITHDRAWN | Plaque Psoriasis |
Stiefel, a GSK Company |
2009-10 | PHASE4 |
| NCT00811005 | UNKNOWN | Pustular Palmoplantar Psoriasis |
Medical University of Vienna |
2008-10 | PHASE3 |
| NCT00707070 | UNKNOWN | Chronic Plaque Psoriasis |
Universita di Verona |
2008-09 | PHASE4 |
| NCT00156247 | COMPLETED | Psoriasis |
University of Medicine and Dentistry of New Jersey |
2005-09 | PHASE2 |
| NCT01039142 | COMPLETED | Psoriasis |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2008-03 | PHASE4 |
| NCT00395941 | COMPLETED | Psoriasis |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2006-12 | PHASE2 |
| NCT01039142 | Completed | Psoriasis |
Post Graduate Institute of Medical Education and Research Chandigarh|PIMERIndia |
2008-03 | Phase 4 |
| NCT00488384 | Withdrawn | Carcinoma Squamous Cell |
Günther Hofbauer|University of Zurich |
2007-06 | Phase 4 |
| NCT00723437 | COMPLETED | Psoriasis |
Istituti Fisioterapici Ospitalieri |
2005-01 | PHASE4 |
| NCT00644384 | COMPLETED | Non-melanomatous Skin Cancer |
Mayo Clinic |
2003-02 | |
| NCT00156247 | Completed | Psoriasis |
University of Medicine and Dentistry of New Jersey|Connetics Corp.|Rutgers The State University of New Jersey |
2005-09 | Phase 2 |
| NCT00003611 | COMPLETED | Non-melanomatous Skin Cancer |
Alliance for Clinical Trials in Oncology |
2000-05 | |
| NCT00002143 | COMPLETED | HIV Infections; Psoriasis |
Hoffmann-La Roche |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2022-11-25)
Check the
Acitretin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.