48 completed, 4 withdrawn, 2 unknown. 19 Phase 2, 11 Phase 1, 11 Phase 3, 6 Phase 4, 2 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 17, Unknown 1, Withdrawn 1 |
| Phase 1 | 11 | Completed 9, Withdrawn 2 |
| Phase 3 | 11 | Completed 11 |
| Phase 4 | 6 | Completed 5, Unknown 1 |
| Early Phase 1 | 2 | Withdrawn 2 |
| Not applicable | 2 | Completed 2 |
Follow 3-ingenyl angelate: new trials by email Literature Review of 3-ingenyl angelate trials Research Report on 3-ingenyl angelate
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 |
|---|---|---|---|---|---|---|
| Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment Ingenol mebutate gel - Actinic Cheilitis | Phase 1 / Phase 2 | Withdrawn | Instituto Nacional de Cancer, Brazil | 2020-02-01 | 2019-06-19 | |
| Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma Picato 0.05% Topical Gel - Carcinoma | Phase 2 | Completed | Centre Hospitalier Universitaire de Nice | 24 | 2018-07-26 | 2023-07-21 |
| Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients Picato - Molluscum Contagiosum | Early Phase 1 | Withdrawn | Center for Clinical Studies, Texas | 2017-12-20 | 2022-04-01 | |
| Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy Ingenol mebutate, cryotherapy - Actinic Keratosis | Phase 4 | Completed | University of Campania Luigi Vanvitelli | 50 | 2017-04-12 | 2019-09-24 |
| Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients ingenol mebutate gel 0.015% - Actinic Keratosis | Phase 4 | Completed | University of California, San Francisco | 20 | 2016-10-06 | 2022-03-09 |
| An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam - ACTINIC KERATOSIS | Phase 3 | Completed | Actavis Inc. | 507 | 2016-08-19 | 2020-01-14 |
| Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands. ingenol mebutate 0.05% gel - Verruca Vulgaris, Common Warts | Phase 1 | Completed | Neal D. Bhatia, MD | 16 | 2016-04-27 | 2017-07-17 |
| The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice Ingenol mebutate - Actinic Keratosis | Completed | LEO Pharma | 440 | 2015-12-01 | 2019-01-22 | |
| Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin Ingenol Mebutate (Picato®) 0.015% gel - Actinic Keratosis, Photo-aged Skin | Not applicable | Completed | Skin Laser & Surgery Specialists | 23 | 2015-11-09 | 2018-04-26 |
| 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 |
| Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp Ingenol Mebutate Gel, 0.015%, Diclofenac sodium gel 3% - Actinic Keratosis (AK) | Phase 4 | Completed | LEO Pharma | 502 | 2015-04-01 | 2025-02-24 |
| Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest Ingenol Mebutate, Vehicle - Actinic Keratosis | Phase 3 | Completed | LEO Pharma | 729 | 2015-04-01 | 2025-03-10 |
| Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts Picato - Anogenital Warts | Phase 2 | Completed | LEO Pharma | 40 | 2015-02-01 | 2025-02-24 |
| A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam - Actinic Keratosis | Phase 3 | Completed | Actavis Inc. | 441 | 2015-02-01 | 2020-05-12 |
| 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 |
| Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis Ingenol mebutate Picato® and MAL PDT day 1, day 5, Ingenol mebutate Picato® day 2, 3, 4, MAL PDT day 5 - Actinic Keratosis | Phase 2 | Unknown | Pacific Dermaesthetics | 20 | 2015-01-01 | 2019-03-26 |
| IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis Imiquimod, 5-fluorouracil, Ingenol mebutate - Keratosis, Actinic | Phase 4 | Unknown | Maastricht University Medical Center | 624 | 2014-11-01 | 2017-10-30 |
| PMS to Evaluate the Safety and Efficacy of Picato® Gel Ingenol mebutate 0.015 percent or 0.05 percent gel - Actinic Keratosis | Completed | LEO Pharma | 1324 | 2014-09-01 | 2019-12-13 | |
| The Real Life Topical Field Treatment of Actinic Keratosis Study Ingenol mebutate, 5-fluorouracil, Imiquimod - Actinic Keratosis | Completed | LEO Pharma | 1168 | 2014-07-01 | 2019-12-13 | |
| Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis ingenol mebutate, 5% 5-FU - Actinic Keratosis | Not applicable | Completed | University of Sao Paulo | 100 | 2014-05-01 | 2014-09-17 |
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Keratosis, Actinic (42) · Carcinoma, Basal Cell (3) · Melanosis (3) · Warts (2) · Actinic cheilitis (1) · Bowen's Disease (1) · Carcinoma (1) · Carcinoma, Squamous Cell (1) · Condylomata Acuminata (1) · Facies (1) · Keratosis (1) · Keratosis, Seborrheic (1) · Molluscum Contagiosum (1)
Peplin (22) · LEO Pharma (15) · Actavis Inc. (2) · Icahn School of Medicine at Mount Sinai (2) · Padagis LLC (2) · Center for Clinical Studies, Texas (1) · Centre Hospitalier Universitaire de Nice (1) · Instituto Nacional de Cancer, Brazil (1) · Maastricht University Medical Center (1) · Neal D. Bhatia, MD (1) · Northwestern University (1) · Pacific Dermaesthetics (1) · Skin Laser & Surgery Specialists (1) · University of California, San Francisco (1) · University of Campania Luigi Vanvitelli (1)
United States (22) · Australia (15) · Germany (5) · France (2) · Italy (2) · Netherlands (2) · Brazil (1) · Denmark (1) · Greece (1) · New Zealand (1) · South Korea (1) · United Kingdom (1)
Greg Siller (3) · Angela Smith (2) · Eugene Bauer, MD (2) · Janelle Katsamas (2) · Jonothan S Dosik, MD (2) · Alicia D Bucko, MD (1) · Arthur P Bertolino, MD (1) · C. William Hanke, MD (1) · Daniel Cohen Goldemberg, PhD (1) · Daniel M Siegel, MD, MS (1) · Eggert Stockfleth, Prof Dr med (1) · Eggert Stockfleth, Prof.Dr.med. (1) · Gary Goldenberg, MD (1) · Giuseppe Argenziano, Prof (1)
PMID 22417254, PMID 24765228, PMID 11966728, PMID 12533168, PMID 15087400, PMID 15168956, PMID 18067627, PMID 20231500, PMID 20546215, PMID 20725550, PMID 22055282, PMID 24672213, PMID 25584134, PMID 25727104, PMID 26239203, PMID 26300464, PMID 27612149, PMID 27672408, PMID 27932240, PMID 29030864, PMID 30855743, PMID 31961446, PMID 33476658, PMID 35475852, PMID 7947197
2014 (1)