Halobetasol

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

• Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

• Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.contraindicated

Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Halobetasol Propionate Ointment should not be used with occlusive dressings.

In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Halobetasol Propionate Ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Pregnancy Teratogenic effects: Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol Propionate Ointment. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits. There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. Halobetasol Propionate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Metabolism

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration.

Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

• Dec 16, 2004ANDAANDA077123Padagis Israel
• Dec 16, 2004ANDAANDA076872Padagis Israel
• Jun 14, 2005ANDAANDA077109Cosette
• Apr 24, 2007ANDAANDA078162Cosette
• Nov 6, 2015NDANDA208183Lacer Pharma
• Nov 6, 2018NDANDA209355Bausch
• Apr 25, 2019NDANDA209354Bausch
• Oct 6, 2020ANDAANDA213560Quagen

1. 1Drug Ineffective27518%
2. 2Psoriasis22715%
3. 3Pruritus1308.7%
4. 4Rash1016.8%
5. 5Product Use In Unapproved Indication1006.7%
6. 6Fatigue805.4%
7. 7Pain785.2%
8. 8Arthralgia684.6%
9. 9Dermatitis Atopic674.5%
10. 10Headache654.4%
11. 11Product Dose Omission Issue644.3%
12. 12Diarrhoea624.2%
13. 13Off Label Use614.1%
14. 14Skin Exfoliation594.0%
15. 15Dry Skin583.9%

The 10 most recently updated of 31 ClinicalTrials.gov registrations naming Halobetasol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
  Terminated · Phase 3 · Interventional · 15 enrolled · Icahn School of Medicine at Mount Sinai
  NCT05608499updated 2025-11-04
• Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults
  Completed · Phase 3 · Interventional · 21 enrolled · Austin Institute for Clinical Research
  NCT05203315updated 2024-07-19
• Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis
  Completed · Phase 4 · Interventional · 10 enrolled · Dermatology Consulting Services, PLLC
  NCT06042647updated 2023-11-18
• A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis
  Completed · Phase 4 · Interventional · 20 enrolled · Dermatology Consulting Services, PLLC
  NCT05872256updated 2023-11-18
• Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
  Completed · Phase 4 · Interventional · 22 enrolled · Icahn School of Medicine at Mount Sinai
  NCT04720105updated 2023-10-27
• Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids
  Completed · Phase 2 · Interventional · 304 enrolled · Citius Pharmaceuticals, Inc.
  NCT05348200updated 2023-08-31
• Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis
  Completed · Interventional · 90 enrolled · Jinnah Postgraduate Medical Centre
  NCT06015152updated 2023-08-29
• Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
  Completed · Phase 4 · Interventional · 24 enrolled · Mayne Pharma International Pty Ltd
  NCT03992261updated 2023-07-06
• 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.
  Completed · Early phase 1 · Interventional · 402 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT05282771updated 2022-03-16
• Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
  Terminated · Phase 4 · Interventional · 16 enrolled · Sun Pharmaceutical Industries Limited
  NCT03212963updated 2021-12-07

Frequently asked questions

How does Halobetasol work?

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

What is Halobetasol used for?

According to FDA labeling, Halobetasol carries indications including: Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Halobetasol?

Halobetasol is classified as Corticosteroids, potent (group III), Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Decreased Immunologically Active Molecule Activity, Decreased Protein Synthesis, Vasoconstriction.

What are the brand names for Halobetasol?

Halobetasol is marketed under brand names including Bryhali, Duobrii, Lexette, Ultravate.

What are the contraindications for Halobetasol?

Halobetasol labeling lists contraindications including: Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.. Always consult the full prescribing information and a clinician.