Ingenol mebutate: Clinical Trials

11 completed, 1 unknown, 1 withdrawn. 3 Phase 4, 2 Phase 1, 1 Early Phase 1, 1 Not applicable, 1 Phase 2.

By phase and status

Phase	Trials	Status
Phase 4	3	Completed 2, Unknown 1
Phase 1	2	Completed 2
Early Phase 1	1	Withdrawn 1
Not applicable	1	Completed 1
Phase 2	1	Completed 1
Phase 3	1	Completed 1

Follow Ingenol mebutate: new trials by email Literature Review of Ingenol mebutate trials Research Report on Ingenol mebutate

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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
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
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
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
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
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
Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions Ingenol mebutate - Actinic Keratosis	Phase 1	Completed	LEO Pharma	79	2014-04-01	2025-02-24
TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction Ingenol mebutate - Actinic Keratosis		Completed	LEO Pharma	1218	2014-04-01	2023-06-09
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis ingenol mebutate, Placebo - Actinic Keratosis	Phase 2	Completed	LEO Pharma	266	2014-01-01	2025-03-10
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks Ingenol Mebutate - Actinic Keratosis		Completed	LEO Pharma	840	2013-07-01	2019-12-17
Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses Ingenol Mebutate, Cryotherapy - Actinic Keratoses	Phase 4	Completed	Icahn School of Medicine at Mount Sinai	16	2013-04-01	2017-04-26
Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions Ingenol mebutate, cryotherapy - Actinic Keratosis	Early Phase 1	Withdrawn	Northwestern University		2012-10-01	2021-12-06
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Ingenol mebutate, Placebo Gel - Actinic Keratosis	Phase 1	Completed	LEO Pharma	24	2011-09-01	2025-03-07

Conditions studied

Keratosis, Actinic (13)

Sponsors

LEO Pharma (8)  ·  Icahn School of Medicine at Mount Sinai (1)  ·  Maastricht University Medical Center (1)  ·  Northwestern University (1)  ·  University of Campania Luigi Vanvitelli (1)  ·  University of Sao Paulo (1)

Countries

United States (4)  ·  Germany (2)  ·  Netherlands (2)  ·  Brazil (1)  ·  Greece (1)  ·  Italy (1)

Top investigators

Alicia D Bucko, MD (1)  ·  C. William Hanke, MD (1)  ·  Daniel M Siegel, MD, MS (1)  ·  Eggert Stockfleth, Prof Dr med (1)  ·  Gary Goldenberg, MD (1)  ·  Giuseppe Argenziano, Prof (1)  ·  Klara Mosterd, MD, PhD (1)  ·  Kostas Sitaras, MD (1)  ·  Luis Antonio Torezan, PhD (1)  ·  Murad Alam, MD (1)  ·  Sarah Moumane, MD (1)  ·  Thomas Diepgen, Prof. Dr. med. (1)

Results publications

PMID 11966728, PMID 12533168, PMID 15168956, PMID 18067627, PMID 20231500, PMID 20725550, PMID 24672213, PMID 25727104, PMID 27672408, PMID 30855743, PMID 31961446, PMID 33476658, PMID 35475852, PMID 7947197

NIH funding

2014 (1)