11 completed, 1 unknown. 6 Phase 2, 5 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 5, Unknown 1 |
| Phase 3 | 5 | Completed 5 |
| Phase 1 | 1 | Completed 1 |
Follow Omiganan: new trials by email Literature Review of Omiganan trials Research Report on Omiganan
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 |
|---|---|---|---|---|---|---|
| Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis Omiganan, Ketoconazole, Placebo - Seborrheic Dermatitis | Phase 2 | Unknown | Maruho Co., Ltd. | 36 | 2018-10-22 | 2019-05-01 |
| Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis Omiganan, Placebo - Atopic Dermatitis | Phase 2 | Completed | Maruho Co., Ltd. | 80 | 2017-03-08 | 2017-12-27 |
| Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers Omiganan, Imiquimod, Omiganan 1% and Imiquimod - Healthy | Phase 1 | Completed | Maruho Co., Ltd. | 16 | 2017-02-06 | 2017-05-22 |
| Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts Omiganan (CLS001) topical gel, Vehicle topical gel - Condylomata Acuminata (External) | Phase 2 | Completed | Maruho Co., Ltd. | 24 | 2016-07-01 | 2017-03-31 |
| Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle CLS001 (Omiganan), Vehicle - Rosacea | Phase 3 | Completed | Maruho Co., Ltd. | 463 | 2015-12-01 | 2022-08-02 |
| Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN Omiganan (CLS001) topical gel, Vehicle topical gel - Usual Type Vulval Intraepithelial Neoplasia (uVIN) | Phase 2 | Completed | Maruho Co., Ltd. | 12 | 2015-11-01 | 2017-08-03 |
| Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle CLS001 (Omiganan), Vehicle - Rosacea | Phase 3 | Completed | Maruho Co., Ltd. | 263 | 2015-10-01 | 2022-08-02 |
| A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris Omiganan (CLS001) Topical Gel, Vehicle Topical Gel - Acne Vulgaris | Phase 2 | Completed | Maruho Co., Ltd. | 320 | 2015-10-01 | 2017-03-27 |
| Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel Omiganan - Rosacea | Phase 3 | Completed | Maruho Co., Ltd. | 307 | 2015-10-01 | 2022-07-19 |
| A Twelve Week Safety and Efficacy Study in Rosacea omiganan, placebo - Papulopustular Rosacea | Phase 2 | Completed | Maruho Co., Ltd. | 240 | 2013-03-01 | 2015-05-20 |
| Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects omiganan 1% gel, chlorhexidine 2% solution - Infection | Phase 3 | Completed | Cadence Pharmaceuticals | 30 | 2008-05-01 | 2010-01-26 |
| Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters Omiganan 1% gel, Povidone-Iodine 10% - Infection | Phase 3 | Completed | Cadence Pharmaceuticals | 1859 | 2005-08-01 | 2009-08-13 |
Rosacea (4) · Infections (2) · Acne Vulgaris (1) · Condylomata Acuminata (1) · Dermatitis, Atopic (1) · Dermatitis, Seborrheic (1)
Maruho Co., Ltd. (10) · Cadence Pharmaceuticals (2)
Netherlands (8) · United States (7) · France (4) · Australia (3) · Canada (3) · Germany (3) · New Zealand (3) · Sweden (3) · United Kingdom (3) · Spain (1)
Catherine J Hardalo, MD (1) · Robert Rissmann, PhD (1)
2016 (2), 2015 (1)