Numerous clinical trials span Phase 1 through Phase 4 to investigate MC903 (calcipotriene) across various indications, including psoriasis vulgaris, nail psoriasis, actinic keratoses, alopecia areata, graft-versus-host disease, and breast cancer immunoprevention. Sponsored by both pharmaceutical companies and academic medical institutions, these studies range from early safety evaluations to post-marketing research. The trial portfolio exhibits varied recruitment statuses, encompassing completed, actively recruiting, not yet recruiting, and terminated studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07352566 | NOT_YET_RECRUITING | Psoriasis; Atopic Dermatitis |
University of California, San Francisco |
2026-08-01 | PHASE4 |
| NCT03370406 | RECRUITING | Carcinoma, Squamous Cell |
Melissa Pugliano-Mauro |
2018-08-03 | PHASE1 |
| NCT06851507 | RECRUITING | Multiple Actinic Keratoses |
M.D. Anderson Cancer Center |
2025-10-06 | PHASE3 |
| NCT05381597 | RECRUITING | Superficial Basal Cell Carcinoma; Squamous Cell Carcinoma in Situ |
Boston University |
2022-10-15 | PHASE2; PHASE3 |
| NCT05699603 | ACTIVE_NOT_RECRUITING | Actinic Keratosis |
University of Arizona |
2024-07-02 | PHASE2 |
| NCT06203470 | Not yet recruiting | Psoriasis Vulgaris |
Assiut University |
2024-06 | Phase 4 |
| NCT04839731 | UNKNOWN | Squamous Cell Carcinoma |
Carilion Clinic |
2021-04-14 | EARLY_PHASE1 |
| NCT04227288 | COMPLETED | Nail Psoriasis |
University of Alabama at Birmingham |
2021-11-01 | PHASE4 |
| NCT05954104 | Completed | Alopecia Areata |
Egymedicalpedia |
2023-07-01 | Not Applicable |
| NCT04555707 | UNKNOWN | Psoriasis |
Derm Research, PLLC |
2020-06-24 | PHASE4 |
| NCT04372277 | RECRUITING | Psoriasis |
Psoriasis Treatment Center of Central New Jersey |
2020-04-28 | PHASE4 |
| NCT03596073 | TERMINATED | Breast Cancer |
Massachusetts General Hospital |
2018-11-07 | PHASE1 |
| NCT03731091 | COMPLETED | Psoriasis Vulgaris |
Glenmark Pharmaceuticals Ltd. India |
2018-10-31 | PHASE3 |
| NCT03996252 | TERMINATED | Actinic Keratoses |
Tulane University |
2019-07-01 | EARLY_PHASE1 |
| NCT03506477 | COMPLETED | Plaque Psoriasis; Psoriasis |
Icahn School of Medicine at Mount Sinai |
2018-05-21 | PHASE4 |
| NCT03827876 | RECRUITING | Psoriasis |
Psoriasis Treatment Center of Central New Jersey |
2019-01-16 | PHASE4 |
| NCT03469336 | COMPLETED | Psoriasis |
Pfizer |
2018-04-24 | PHASE1 |
| NCT03093805 | COMPLETED | Graft Vs Host Disease |
Children's Hospital Medical Center, Cincinnati |
2017-03-15 | |
| NCT03448081 | COMPLETED | Pruritus; Psoriasis |
Sienna Biopharmaceuticals |
2018-02-12 | PHASE2 |
| NCT03596073 | Terminated | Breast Cancer |
Massachusetts General Hospital |
2018-11-07 | Phase 1 |
| NCT03331523 | COMPLETED | Scalp Psoriasis |
Glenmark Pharmaceuticals Ltd. India |
2017-10-20 | PHASE3 |
| NCT03584360 | COMPLETED | Psoriasis Vulgaris |
Centre Hospitalier Universitaire de Nice |
2018-09-24 | PHASE2 |
| NCT01582932 | COMPLETED | Psoriasis |
Mayne Pharma International Pty Ltd |
2013-04 | PHASE1 |
| NCT03079973 | WITHDRAWN | Nail Psoriasis |
Polichem S.A. |
2017-05-15 | PHASE3 |
| NCT03476746 | Completed | Healthy |
LEO Pharma |
2018-03-20 | Phase 1 |
| NCT03122353 | COMPLETED | Scalp Psoriasis |
Tolmar Inc. |
2017-04-11 | PHASE1 |
| NCT03080545 | COMPLETED | Psoriasis |
Psoriasis Treatment Center of Central New Jersey |
2017-05-01 | PHASE4 |
| NCT02680717 | WITHDRAWN | Scleroderma |
Medical College of Wisconsin |
2016-03 | PHASE1 |
| NCT02858713 | COMPLETED | Adherence |
Odense University Hospital |
2017-01-09 | PHASE4 |
| NCT02940002 | COMPLETED | Psoriasis |
Bayer |
2016-10-12 | PHASE1 |
| NCT02411643 | TERMINATED | Morphea; Localized Scleroderma |
Northwestern University |
2015-03 | EARLY_PHASE1 |
| NCT01563068 | COMPLETED | Psoriasis |
Mayne Pharma International Pty Ltd |
2012-04 | PHASE1 |
| NCT01745133 | COMPLETED | Psoriasis |
Leon Kircik, M.D. |
2013-01 | PHASE4 |
| NCT01694433 | COMPLETED | Acne Vulgaris |
University of California, Los Angeles |
2013-02 | PHASE2; PHASE3 |
| NCT03399526 | COMPLETED | Psoriasis |
Bayer |
2013-02-11 | PHASE1 |
| NCT00817219 | COMPLETED | Psoriasis Vulgaris |
LEO Pharma |
2009-07 | PHASE2 |
| NCT01188928 | COMPLETED | Psoriasis Vulgaris |
LEO Pharma |
2010-09 | PHASE3 |
| NCT01268527 | COMPLETED | Psoriasis Vulgaris |
Eisai Limited |
2010-03-15 | PHASE2 |
| NCT01139580 | COMPLETED | Psoriasis |
Stiefel, a GSK Company |
2010-05 | PHASE3 |
| NCT00608777 | TERMINATED | Plaque Psoriasis |
Derm Research, PLLC |
2008-01 | PHASE4 |
| NCT00820950 | COMPLETED | Psoriasis |
Incyte Corporation |
2007-05-31 | PHASE2 |
| NCT00625326 | COMPLETED | Plaque-type Psoriasis |
Deltanoid Pharmaceuticals |
2008-01 | PHASE2 |
| NCT00437255 | COMPLETED | Plaque Psoriasis |
Galderma R&D |
2006-08 | PHASE4 |
| NCT00279162 | COMPLETED | Psoriasis |
LEO Pharma |
2005-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-03)
Check the
MC903 (Calcipotriene)
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.