Clobetasol propionate

Overview

Clobetasol propionate is a prednisolone derivative with higher specificity for glucocorticoid receptors than mineralocorticoid receptors. It has demonstrated superior activity compared to fluocinonide and was first described in the literature in 1974. Clobetasol Propionate was granted FDA approval on 27 December 1985.

Indication

Clobetasol propionate is indicated to treat moderate to severe plaque psoriasis as well as inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Associated Conditions

Alopecia
Severe Plaque psoriasis
Corticosteroid responsive, Inflammatory Dermatosis
Corticosteroid responsive, pruritic Dermatosis
Moderate Plaque psoriasis
Moderate Scalp Psoriasis
Severe Scalp Psoriasis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Comparison of Photodynamic Therapy and Topical Clobetasol in Treatment of Oral Lichen Planus: a Split-Mouth Randomised Controlled Study	2024/12/30	NCT06752343	Phase 2	Completed	Wroclaw Medical University
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?	2024/12/19	NCT06742333	Phase 2	Recruiting	Centre Hospitalier Universitaire de Nice
Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis	2024/08/15	NCT06555497	Early Phase 1	Completed	Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)	2024/07/16	NCT06504160	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
Silver Nitrate Versus Topical Steroid For Umbilical Granuloma	2024/04/12	NCT06363539	Phase 2	Completed	Children Hospital and Institute of Child Health, Lahore
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus	2023/04/19	NCT05818618	Not Applicable	Completed	University of Catania
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population	2023/02/13	NCT05724446	Phase 3	Recruiting	Salvat
Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis	2023/01/31	NCT05706870	Phase 2	Completed	GEN İlaç ve Sağlık Ürünleri A.Ş.
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva	2022/05/06	NCT05364515	Phase 3	Withdrawn	Fundación Eduardo Anitua
Laser Vs Clobetasol for Lichen Sclerosus	2021/08/18	NCT05010421	Phase 3	Recruiting	Ruhr University of Bochum

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Clobetasol Propionate	Physicians Total Care, Inc.	54868-3584	TOPICAL	0.5 mg in 1 g	4/2/2012
Clobetasol Propionate	Taro Pharmaceuticals U.S.A., Inc.	51672-4193	TOPICAL	0.5 mg in 1 g	8/18/2020
Clobetasol Propionate	Glenmark Pharmaceuticals Inc., USA	68462-608	TOPICAL	0.5 mg in 1 g	6/21/2022
Clobetasol Propionate	HyGen Pharmaceuticals, Inc.	70030-166	TOPICAL	0.4625 mg in 1 mL	3/23/2018
clobetasol propionate	Rebel Distributors Corp	21695-201	TOPICAL	0.5 mg in 1 g	11/5/2009
CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	62332-486	TOPICAL	0.5 mg in 1 mL	12/12/2023
Clobetasol Propionate	Akorn	50383-979	TOPICAL	.5 mg in 1 mL	3/11/2022
Clobetasol Propionate	Teligent Pharma, Inc.	52565-055	TOPICAL	.05 mg in 100 mL	9/10/2019
CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	62332-547	TOPICAL	0.5 mg in 1 g	3/14/2024
Clobetasol Propionate ANDA	Macleods Pharmaceuticals Limited	33342-506	TOPICAL	0.5 mg in 1 g	1/5/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MEDODERMONE OINTMENT 0.05%	MEDOCHEMIE LTD (COGOLS FACILITY)	SIN06530P	OINTMENT	0.05% w/w	8/27/1991
DERMOVATE OINTMENT 0.05% w/w	GLAXO WELLCOME OPERATIONS, Delpharm Poznan S.A.	SIN04933P	OINTMENT	0.05% w/w	7/12/1990
CLODERM CREAM 0.05% w/w	HOE PHARMACEUTICALS SDN BHD	SIN10241P	CREAM	0.5 mg/g	10/10/1998
Clobex Lotion 0.05%	DPT Laboratories, Ltd	SIN13291P	LOTION	0.05%	6/14/2007
DERMOSOL CREAM 0.5 mg/g	Y S P INDUSTRIES (M) SDN BHD	SIN10297P	CREAM	0.5 mg/g	10/26/1998
CLODERM OINTMENT 0.05%	HOE PHARMACEUTICALS SDN BHD	SIN09101P	OINTMENT	0.05% w/w	12/20/1996
LOBESOL CREAM 0.05% w/w	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN07878P	CREAM	0.05% w/w	10/20/1994
UNIVATE OINTMENT 0.05%	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN09220P	OINTMENT	0.05% w/w	2/20/1997
DERMOVATE CREAM 0.05% w/w	GLAXO WELLCOME OPERATIONS, Delpharm Poznan S.A.	SIN04934P	CREAM	0.05% w/w	7/12/1990
STERIDERM-S CREAM 0.05%	MICRO LABS LTD	SIN09580P	CREAM	0.05% w/w	12/15/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
NIZOKOMP CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	3/21/2003
TRIDAZINE-FORTE CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/28/2009
FORTIN CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/23/2000
XYLOPAN CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	3/11/1999
LAMEBA CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	3/21/2000
RAPIDERM CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	8/23/1999
MCKAY CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	3/26/2003
BENZACIN CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	8/23/1999
POLYSTATIN CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	5/30/2001
GAMMACIN CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	3/21/2003

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CLOXOBET CREAM clobetasol propionate 0.05% w/w cream tube	386558	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023
CLOBEX clobetasol propionate 500 microgram/mL Shampoo Application Bottle	188346	Galderma Australia Pty Ltd	Medicine	A	3/21/2013
DPL-CLOBETASOL CREAM clobetasol propionate 0.05% w/w cream tube	386557	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023
CLOXOBET OINTMENT clobetasol propionate 0.05% w/w ointment tube	386562	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023
XOBET OINTMENT clobetasol propionate 0.05% w/w ointment tube	386560	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023
XOBET CREAM clobetasol propionate 0.05% w/w cream tube	386556	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023
DPL-CLOBETASOL OINTMENT clobetasol propionate 0.05% w/w ointment tube	386561	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/20/2023

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