Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate clobetasol propionate for inflammatory and autoimmune dermatological conditions, including plaque-type psoriasis, vulvar lichen sclerosus, oral lichen planus, and bullous pemphigoid. Sponsored by a range of pharmaceutical companies and academic institutions, these studies evaluate therapeutic efficacy and safety across completed, actively recruiting, and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06135402 RECRUITING
Lichen Sclerosus
Kantonsspital Winterthur KSW
 2023-11-10
NCT07666620 NOT_YET_RECRUITING
Hypertrophic Lichen Planus
Noor Aziz
 2026-10-01 PHASE4
NCT07240389 NOT_YET_RECRUITING
Vulvar Lichen Sclerosus
Milosz Pietrus
 2025-12-01
NCT07278999 RECRUITING
Oral Lichen Planus; Erosive Lichen Planus; Mucosal Lesions
Medical University of Silesia
 2025-12-01
NCT07641725 RECRUITING
Oral Lesions in Patients With Pemphigus Vulgaris
Damascus University
 2025-11-01
NCT07398807 RECRUITING
Vitiligo
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
 2025-08-08 EARLY_PHASE1
NCT05724446 RECRUITING
Cataracts Infantile
Salvat
 2022-12-12 PHASE3
NCT03926377 COMPLETED
Osteoporosis; Bullous Pemphigoid
Centre Hospitalier Universitaire, Amiens
 2020-12-11 PHASE4
NCT06856590 COMPLETED
Hand-Foot Skin Reaction (HFSR)
Gazi University
 2025-02-20
NCT04951206 COMPLETED
Vulvar Lichen Sclerosus
Medstar Health Research Institute
 2022-03-01 PHASE4
NCT03926299 COMPLETED
Chronic Skin Disease; Vulvar Lichen Sclerosus
Prof. Dr. Volker Viereck
 2019-07-15
NCT04364555 ACTIVE_NOT_RECRUITING
Oral Lichen Planus
Malmö University
 2020-05-18 PHASE2; PHASE3
NCT05364515 WITHDRAWN
Lichen Sclerosus of Vulva
Fundación Eduardo Anitua
 2021-12-23 PHASE3
NCT06555497 COMPLETED
Pilot Study; Psoriasis
Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
 2022-01-01 EARLY_PHASE1
NCT04649697 UNKNOWN
Rheumatoid Arthritis
Cairo University
 2020-12-01 PHASE3
NCT06042647 COMPLETED
Psoriasis Vulgaris
Dermatology Consulting Services, PLLC
 2023-07-13 PHASE4
NCT06119672 UNKNOWN
Oral Lichen Planus
October 6 University
 2023-05-01 PHASE3
NCT05885269 COMPLETED
Alopecia Areata
Combined Military Hospital Abbottabad
 2022-11-01 PHASE1
NCT06363539 COMPLETED
Umbilical Granuloma
Children Hospital and Institute of Child Health, Lahore
 2022-09-20 PHASE2
NCT07536737 COMPLETED
Oral Lichen Planus
Medical University of Bialystok
 2021-09-30
NCT04246801 COMPLETED
Cataract
Salvat
 2020-06-10 PHASE3
NCT04249076 COMPLETED
Cataract
Salvat
 2020-06-04 PHASE3
NCT03847389 TERMINATED
Atopic Dermatitis
Hill Dermaceuticals, Inc.
 2019-09-09 PHASE1; PHASE2
NCT03592342 COMPLETED
Oral Lichen Planus
Dermtreat
 2018-06-28 PHASE2
NCT02573883 COMPLETED
Vulvar Lichen Sclerosus
Medstar Health Research Institute
 2015-10 PHASE3
NCT03779360 COMPLETED
Inflammation; Skin
Centre for Human Drug Research, Netherlands
 2018-10-12
NCT03758365 COMPLETED
Vasoconstriction
MC2 Therapeutics
 2018-11-05 PHASE1
NCT03386643 COMPLETED
Oral Lichen Planus
University of Sao Paulo
 2017-11-06 PHASE2
NCT03026478 UNKNOWN
Oral Lichen Planus
Garlapati Komali
 2016-05-06 PHASE2
NCT02368886 COMPLETED
Colon Adenocarcinoma; Rectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v7; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IV Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7
Academic and Community Cancer Research United
 2015-03-27 PHASE2
NCT03535233 COMPLETED
Alopecia Areata
Cairo University
 2016-03 PHASE4
NCT03179605 Terminated
Psoriasis
Primus Pharmaceuticals|Prosoft Clinical
 2017-05-02 Phase 2
NCT02936492 TERMINATED
Psoriasis
Bayer
 2016-10-24 PHASE1
NCT02360202 COMPLETED
Bullous Pemphigoid
University Hospital, Rouen
 2015-02-17 PHASE4
NCT02940002 COMPLETED
Psoriasis
Bayer
 2016-10-12 PHASE1
NCT02416531 COMPLETED
Vulvar Lichen Sclerosus
Daniela de Fátima Teixeira da Silva
 2015-01
NCT02492373 COMPLETED
Lentigines; Post Inflammatory Hyperpigmentation
Mahidol University
 2015-02
NCT02131324 COMPLETED
Psoriasis
Promius Pharma, LLC
 2014-05-08 PHASE2
NCT02733874 COMPLETED
Psoriasis
First Hospital of China Medical University
 2015-04 PHASE4
NCT02376049 COMPLETED
Atopic Dermatitis
LEO Pharma
 2015-02 PHASE1
NCT02392130 COMPLETED
Skin Tissue Diseases; Connective Tissue Diseases
LEO Pharma
 2015-03 PHASE1
NCT02313870 COMPLETED
Bullous Pemphigoid
University Hospital, Montpellier
 2008-01-22 PHASE3
NCT02355639 COMPLETED
Skin and Connective Tissue Diseases
LEO Pharma
 2015-01 PHASE1
NCT02487212 COMPLETED
Hypertrophic Scars
Mahidol University
 2014-04 PHASE4
NCT01282515 COMPLETED
Genital Lichen Planus
Oslo University Hospital
 2011-08 PHASE2; PHASE3
NCT01126255 TERMINATED
Vulvar Lichen Sclerosus
Insel Gruppe AG, University Hospital Bern
 2011-03 PHASE2
NCT01745133 COMPLETED
Psoriasis
Leon Kircik, M.D.
 2013-01 PHASE4
NCT01893567 COMPLETED
Plaque Psoriasis
Galderma R&D
 2013-07 PHASE4
NCT01703325 COMPLETED
Psoriatic Nails
Mahidol University
 2010-11 PHASE4
NCT01235442 COMPLETED
Psoriasis
Amgen
 2010-09 PHASE3
NCT01381445 COMPLETED
Dermatitis, Atopic
GlaxoSmithKline
 2011-04-14 PHASE1
NCT01323673 COMPLETED
Dermatitis, Chronic
Stiefel, a GSK Company
 2010-11-15 PHASE4
NCT00715975 COMPLETED
Psoriasis
Azidus Brasil
 2008-07 PHASE2; PHASE3
NCT01043224 COMPLETED
Psoriasis Vulgaris
LEO Pharma
 2010-01 PHASE1
NCT00988637 COMPLETED
Plaque Psoriasis
Galderma R&D
 2009-10 PHASE4
NCT01111981 UNKNOWN
Alopecia
Callender Center for Clinical Research
 2009-10 PHASE4
NCT00862654 COMPLETED
Scalp Seborrheic Dermatitis
Galderma R&D
 2009-03 PHASE3
NCT00881868 COMPLETED
Scalp Psoriasis
Galderma R&D
 2009-04 PHASE4
NCT00757874 COMPLETED
Vulvar Lichen Sclerosus
Deana Funaro
 2006-04 PHASE2
NCT00852761 COMPLETED
Plaque-Type Psoriasis
Stiefel, a GSK Company
 2009-03 PHASE4
NCT00828464 COMPLETED
Hand Dermatosis
Stiefel, a GSK Company
 2008-10 PHASE4
NCT00658788 COMPLETED
Psoriasis
Galderma R&D
 2008-03 PHASE3
NCT00733954 COMPLETED
Plaque Psoriasis
Galderma R&D
 2007-08 PHASE4
NCT00438399 COMPLETED
Scalp Psoriasis
Galderma R&D
 2007-02 PHASE3
NCT00842153 COMPLETED
Psoriasis
Stiefel, a GSK Company
 2007-11 PHASE4
NCT00437255 COMPLETED
Plaque Psoriasis
Galderma R&D
 2006-08 PHASE4
NCT00436540 COMPLETED
Psoriasis
Galderma R&D
 2006-03 PHASE4
NCT00757874 Completed
Vulvar Lichen Sclerosus
Deana Funaro|Astellas Pharma Inc|St. Justine''s Hospital
 2006-04 Phase 2
NCT00864500 COMPLETED
Healthy
Actavis Inc.
 2005-11 PHASE1
NCT01453686 COMPLETED
Alopecia Areata
The Hospital for Sick Children
 2002-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-23)

Check the Clobetasol propionate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clobetasol propionate selectively binds to cytosolic glucocorticoid receptors, inducing receptor translocation to the nucleus to repress pro-inflammatory gene transcription and inhibit cytokine release, thereby dampening inflammatory cell recruitment and activation. This potent immunosuppressive and anti-inflammatory activity suppresses epidermal proliferation and vascular permeability, providing therapeutic efficacy in clinical conditions such as psoriasis, lichen sclerosus, and severe inflammatory dermatoses.

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.