14 completed, 2 terminated, 1 withdrawn. 7 Phase 2, 4 Phase 1, 2 Phase 3, 2 Phase 4, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 4 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
Follow halobetasol: new trials by email Literature Review of halobetasol trials Research Report on halobetasol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis 0.01% Halobetasol, 0.045% Tazarotene, 0.05% Clobetasol Propionate - Psoriasis Vulgaris | Phase 4 | Completed | Dermatology Consulting Services, PLLC | 10 | 2023-07-13 | 2023-11-18 |
| Duobrii Treatment of Acne Keloidalis Nuchae (AKN) Duobrii, Placebo, Bryhali - Acne Keloidalis Nuchae, AKN | Phase 3 | Terminated | Icahn School of Medicine at Mount Sinai | 15 | 2022-10-26 | 2025-11-04 |
| Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids Monad 1, Monad 2, Monad 3 - Hemorrhoids | Phase 2 | Completed | Citius Pharmaceuticals, Inc. | 304 | 2022-04-22 | 2023-08-31 |
| 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. Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%, Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%, Placebo - Plaque Psoriasis | Early Phase 1 | Completed | Sun Pharmaceutical Industries, Inc. | 402 | 2021-04-16 | 2022-03-16 |
| Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis Duobrii® - Palmoplantar Psoriasis, Plaque Psoriasis | Phase 4 | Completed | Icahn School of Medicine at Mount Sinai | 22 | 2020-11-19 | 2023-10-27 |
| Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis Treatment with Halobetasol propionate 0.05% topical spray - Atopic Dermatitis | Phase 2 | Terminated | Sun Pharmaceutical Industries Limited | 20 | 2017-07-24 | 2019-09-25 |
| Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis Halobetasol Propionate - Plaque Psoriasis | Phase 2 | Withdrawn | Sun Pharmaceutical Industries Limited | 2017-01-01 | 2021-06-14 | |
| Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis IDP-122 Vehicle Lotion, IDP-122 Vehicle Cream, IDP-122 Lotion - Psoriasis | Phase 2 | Completed | Bausch Health Americas, Inc. | 150 | 2016-06-01 | 2020-08-27 |
| Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis IDP-118 Vehicle Lotion, IDP-118 Vehicle Cream, IDP-118 Lotion - Psoriasis | Phase 2 | Completed | Bausch Health Americas, Inc. | 154 | 2016-04-01 | 2020-08-20 |
| Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis IDP-118 Lotion, HP Monad Lotion, Ultravate Cream - Psoriasis | Phase 1 | Completed | Bausch Health Americas, Inc. | 94 | 2015-04-01 | 2017-06-09 |
| Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis Halobetasol 0.05% ointment, Placebo Ointment - Psoriasis | Phase 1 | Completed | Patel, Rita Vikram, M.D. | 10 | 2011-06-01 | 2011-07-28 |
| Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis Halobetasol Proprionate Lotion 0.05%, Halobetasol Proprionate Cream 0.05% - Plaque Psoriasis | Phase 2 | Completed | Therapeutics, Inc. | 43 | 2010-07-01 | 2016-05-16 |
| Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis halobetasol, clobetasol - Psoriasis | Phase 2 / Phase 3 | Completed | Azidus Brasil | 140 | 2008-07-01 | 2010-09-02 |
| Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams Halobetasol Propionate 0.05% Cream-Reference Product, Halobetasol Propionate 0.05% Cream-Test product 1, Halobetasol Propionate 0.05% Cream-Test Product 2 - Healthy | Completed | Padagis LLC | 60 | 2004-01-01 | 2021-10-18 | |
| Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects Halobetasol Propionate 0.05% Ointment, single exposure, Ultravate® 0.05% ointment, single exposure - Healthy | Phase 1 | Completed | Actavis Inc. | 71 | 2003-12-01 | 2010-08-17 |
| The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects Ultravate® 0.05% ointment, single exposure - Healthy | Phase 1 | Completed | Actavis Inc. | 20 | 2003-12-01 | 2010-08-17 |
| Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments Halobetasol Propionate 0.05% Ointment-Reference Product, Halobetasol Propionate 0.05% Ointment-Test Product - Healthy | Completed | Padagis LLC | 76 | 2003-07-01 | 2021-10-15 |
Psoriasis (6) · Acne Keloid (1) · Dermatitis, Atopic (1) · Hemorrhoids (1) · Plaque, Amyloid (1)
Bausch Health Americas, Inc. (3) · Actavis Inc. (2) · Icahn School of Medicine at Mount Sinai (2) · Padagis LLC (2) · Sun Pharmaceutical Industries Limited (2) · Azidus Brasil (1) · Citius Pharmaceuticals, Inc. (1) · Dermatology Consulting Services, PLLC (1) · Patel, Rita Vikram, M.D. (1) · Sun Pharmaceutical Industries, Inc. (1) · Therapeutics, Inc. (1)
United States (12) · Brazil (1)
Binu J Alexander, MD (2) · Paul A. Lehman,, M.Sc. (2) · Alan Lader, PhD (1) · Alice Gottlieb, MD, PhD (1) · Benjamin N Ungar (1) · Binu Alexander (1) · Lindsey Mathew (1) · Rajinder K Jalali, MD (1) · Zaidoon A. Al-Zubaidy (1)