Ulobetasol

Overview

Ulobetasol is a highly potent corticosteroid. It is structurally related to clobetasol. Due to its high potency, it is mainly prescribed in the treatment of severe plaque psoriasis and corticosteroid responsive dermatoses. Ulobetasol was granted FDA approval on 17 December 1990.

Indication

Ulobetasol cream and ointment are indicated in the treatment of inflammatory and pruritic corticosteroid responsive dermatoses. Ulobetasol lotion is indicated in the treatment of plaque psoriasis.

Associated Conditions

Psoriasis Vulgaris (Plaque Psoriasis)
Corticosteroid responsive, Inflammatory Dermatosis
Corticosteroid responsive, pruritic Dermatosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis	2023/09/18	NCT06042647	Phase 4	Completed	Dermatology Consulting Services, PLLC
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)	2022/11/08	NCT05608499	Phase 3	Active, not recruiting	Icahn School of Medicine at Mount Sinai
A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.	2022/03/16	NCT05282771	Early Phase 1	Completed	Taro Pharmaceuticals USA
Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis	2020/09/30	NCT04571151	Phase 4	UNKNOWN	Skin Sciences, PLLC
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis	2019/06/20	NCT03992261	Phase 4	Completed	Mayne Pharma International Pty Ltd
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis	2017/10/02	NCT03298581	Phase 2	Withdrawn	Sun Pharmaceutical Industries Limited
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%	2017/07/11	NCT03212963	Phase 4	Terminated	Sun Pharmaceutical Industries Limited
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis	2017/02/23	NCT03058744	Phase 1	Completed	Bausch Health Americas, Inc.
Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis	2016/05/27	NCT02785172	Phase 2	Completed	Bausch Health Americas, Inc.
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis	2016/05/27	NCT02785185	Phase 2	Completed	Bausch Health Americas, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Halobetasol Propionate	Physicians Total Care, Inc.	54868-4907	TOPICAL	0.5 mg in 1 g	10/27/2010
Halobetasol Propionate	Physicians Total Care, Inc.	54868-5482	TOPICAL	0.5 mg in 1 g	10/27/2010
Duobrii	Bausch Health US, LLC	0187-0653	TOPICAL	0.1 mg in 1 g	1/1/2020
Halobetasol Propionate	Bryant Ranch Prepack	72162-2258	TOPICAL	0.5 mg in 1 g	2/23/2024
Halobetasol Propionate	Bryant Ranch Prepack	63629-8665	TOPICAL	0.5 mg in 1 g	7/18/2023
Halobetasol propionate	Mayne Pharma	51862-606	TOPICAL	0.5 mg in 1 g	3/31/2023
Ultravate	Sun Pharmaceutical Industries, Inc.	10631-122	TOPICAL	0.5 mg in 1 g	9/2/2020
Halobetasol Propionate	Taro Pharmaceuticals U.S.A., Inc.	51672-1322	TOPICAL	0.5 mg in 1 g	1/29/2020
Halobetasol Propionate	Taro Pharmaceuticals U.S.A., Inc.	51672-1321	TOPICAL	0.5 mg in 1 g	5/12/2017
LEXETTE	Mayne Pharma	51862-604	TOPICAL	0.5 mg in 1 g	3/31/2023

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BRYHALI	bausch health, canada inc.	02506262	Lotion - Topical	0.01 % / W/W	8/6/2021
DUOBRII	bausch health, canada inc.	02499967	Lotion - Topical	0.01 % / W/W	8/4/2020
ULTRAVATE	bausch health, canada inc.	01962701	Cream - Topical	0.05 % / W/W	12/31/1993
ULTRAVATE	bausch health, canada inc.	01962728	Ointment - Topical	0.05 % / W/W	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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