37 completed. 22 Phase 3, 5 Not applicable, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Completed 22 |
| Not applicable | 5 | Completed 5 |
| Phase 1 | 3 | Completed 3 |
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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 |
|---|---|---|---|---|---|---|
| Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis roflumilast cream 0.3%, Zoryve, Placebo - Plaque Psoriasis | Phase 3 | Completed | Padagis LLC | 416 | 2023-02-07 | 2026-08-26 |
| To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes Brinzolamide/brimonidine ophthalmic suspension, Simbrinza 0.2%/1% Ophthalmic Suspension - Glaucoma, Open-Angle, Ocular Hypertension | Phase 3 | Completed | Padagis LLC | 447 | 2021-05-28 | 2025-04-02 |
| To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions Mupirocin Calcium, Vehicle - Secondarily Infected Traumatic Skin Lesions | Phase 3 | Completed | Padagis LLC | 657 | 2019-10-15 | 2022-11-03 |
| To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes Brinzolamide 1% ophthalmic suspension, Azopt 1% Ophthalmic Suspension - Glaucoma, Open-Angle, Ocular Hypertension | Phase 3 | Completed | Padagis LLC | 495 | 2019-06-24 | 2023-03-06 |
| Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face Adapalene and Benzoyl Peroxide Topical Gel, Epiduo Topical Product, Placebo - Acne Vulgaris | Phase 3 | Completed | Padagis LLC | 825 | 2017-12-13 | 2021-11-08 |
| An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea Oxymetazoline - Rosacea, Erythema | Phase 3 | Completed | Padagis LLC | 50 | 2017-10-18 | 2021-11-08 |
| Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face Azelaic acid foam, Azelaic acid foam - Placebo - Rosacea | Phase 3 | Completed | Padagis LLC | 667 | 2016-11-01 | 2021-11-08 |
| Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy estrace cream (Perrigo), estrace cream (Reference), Placebo cream - Atrophy | Phase 3 | Completed | Padagis LLC | 695 | 2016-05-01 | 2021-11-02 |
| Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea Ivermectin, Ivermectin (reference), Placebo - Rosacea | Phase 3 | Completed | Padagis LLC | 486 | 2016-05-01 | 2021-11-02 |
| Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris Clindamycin and Benzoyl Peroxide Gel (combination), Clindamycin and Benzoyl Peroxide Gel (Reference) (combination), Placebo gel (combination) - Acne | Phase 3 | Completed | Padagis LLC | 890 | 2015-07-01 | 2021-11-08 |
| To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference), Placebo gel - Actinic Keratosis | Phase 3 | Completed | Padagis LLC | 469 | 2015-05-01 | 2021-11-02 |
| Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea Brimonidine Topical Gel, 0.33 percent (Perrigo), Brimonidine Topical Gel, 0.33 percent (Reference), Placebo gel - Rosacea | Phase 3 | Completed | Padagis LLC | 552 | 2015-03-01 | 2021-10-22 |
| To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference), Placebo gel - Actinic Keratosis | Phase 3 | Completed | Padagis LLC | 519 | 2015-02-01 | 2021-11-02 |
| Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis Acyclovir 5 percent (Perrigo), Acyclovir 5 percent (Reference), Placebo cream - Herpes Labialis | Phase 3 | Completed | Padagis LLC | 4076 | 2014-10-06 | 2021-10-22 |
| Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray, Placebo nasal spray - Seasonal Allergic Rhinitis | Phase 3 | Completed | Padagis LLC | 951 | 2014-08-01 | 2021-10-22 |
| A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR) Mometasone furoate, Nasonex Nasal Spray, Placebo nasal spray - Seasonal Allergic Rhinitis | Phase 3 | Completed | Padagis LLC | 1220 | 2012-08-01 | 2021-10-22 |
| A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%, Acanya Gel, Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product - Acne | Phase 3 | Completed | Padagis LLC | 1180 | 2012-02-01 | 2021-10-22 |
| Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris Adapalene and Benzoyl Peroxide Gel, Adapalene and Benzoyl Peroxide Gel (Reference), Placebo gel - Acne | Phase 3 | Completed | Padagis LLC | 903 | 2011-12-01 | 2021-11-02 |
| Safety and Maintenance Study of Entocort for Children With Crohn's Disease Entocort - Crohn's Disease | Phase 3 | Completed | Padagis LLC | 55 | 2011-12-01 | 2022-01-06 |
| Safety Study of Entocort for Children With Crohn's Disease Entocort - Crohn's Disease | Phase 3 | Completed | Padagis LLC | 123 | 2011-11-01 | 2022-01-06 |
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Acne Vulgaris (6) · Rosacea (4) · Candidiasis, Vulvovaginal (2) · Crohn Disease (2) · Glaucoma, Open-Angle (2) · Keratosis, Actinic (2) · Ocular Hypertension (2) · Rhinitis, Allergic, Seasonal (2) · Tinea Pedis (2) · Atrophy (1) · Candidiasis (1) · Erythema (1) · Herpes Labialis (1)
Budesonide (3) · 3-ingenyl angelate (2) · Adapalene (2) · Clindamycin (2) · Fluticasone (2) · Mometasone Furoate (2) · brinzolamide (2) · clindamycin phosphate benzoyl peroxide combination (2) · halobetasol (2) · Acanya Gel (1) · Benzoyl Peroxide (1) · Clobetasol (1) · Flavoxate (1) · Ivermectin (1) · Mesalamine (1)
United States (17) · Canada (2) · Germany (2) · Italy (2) · Poland (2)
Stanley Cohen, MD (2) · Stefan Eklund, MD (2)