Peplin: Clinical Trials

28 completed, 1 withdrawn. 14 Phase 2, 7 Phase 1, 5 Phase 3.

By phase and status

Phase	Trials	Status
Phase 2	14	Completed 14
Phase 1	7	Completed 6, Withdrawn 1
Phase 3	5	Completed 5

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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
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities PEP005 (ingenol mebutate) Gel, 0.05%, Aluminium disk, OpSite(TM) disk - Superficial Basal Cell Carcinoma	Phase 2	Completed	Peplin	75	2011-04-01	2016-02-26
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects PEP005 Gel - Healthy, Actinic Keratosis	Phase 1	Completed	Peplin	100	2011-02-01	2015-09-14
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin PEP005 (ingenol mebutate) Gel - Photo-damage	Phase 2	Completed	Peplin	24	2010-10-01	2011-01-25
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis PEP005 (ingenol mebutate) Gel - Seborrheic Keratosis	Phase 2	Completed	Peplin	24	2010-10-01	2011-01-25
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Lesion count - Actinic Keratosis		Completed	Peplin	43	2009-09-01	2015-03-26
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies Lesion count - Actinic Keratosis		Completed	Peplin	117	2009-08-01	2015-03-26
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations PEP005 (ingenol mebutate) Gel, Vehicle gel - Actinic Keratoses	Phase 3	Completed	Peplin	203	2009-07-01	2015-03-06
A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study Lesion count - Actinic Keratosis		Completed	Peplin	98	2009-07-01	2015-03-26
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp) PEP005 (Ingenol Mebutate) gel, 0.015%, Vehicle Gel - Actinic Keratosis	Phase 3	Completed	Peplin	278	2009-06-01	2015-03-06
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities) PEP005 Gel - Actinic Keratosis	Phase 3	Completed	Peplin	102	2009-06-01	2015-04-15
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp) PEP005 Gel, Vehicle gel - Actinic Keratosis	Phase 3	Completed	Peplin	269	2009-06-01	2015-04-02
A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis PEP005 (ingenol mebutate) Gel, 0.05%, Vehicle Gel - Actinic Keratosis	Phase 2	Completed	Peplin	16	2009-03-01	2015-03-06
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers PEP005 (ingenol mebutate) Gel - Actinic Keratosis	Phase 1	Completed	Peplin	50	2009-02-01	2015-09-09
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers PEP005 (ingenol mebutate) Gel - Actinic Keratosis	Phase 1	Completed	Peplin	30	2009-02-01	2015-09-09
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations PEP005 (ingenol mebutate) Gel, Vehicle gel - Actinic Keratoses	Phase 3	Completed	Peplin	255	2008-09-01	2015-03-06
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp) PEP005 Topical Gel, Vehicle gel - Actinic Keratosis	Phase 2	Completed	Peplin	265	2008-06-01	2015-04-14
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2 PEP005 Topical gel - Actinic Keratosis	Phase 1	Completed	Peplin	64	2008-04-01	2015-09-14
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s) PEP005 - Warts	Phase 1	Withdrawn	Peplin		2007-10-01	2016-01-28
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand PEP005 gel - Actinic Keratosis	Phase 2	Completed	Peplin	12	2007-10-01	2015-04-02
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005 PEP005 - Actinic Keratoses	Phase 1	Completed	Peplin	8	2007-10-01	2015-02-12

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Conditions studied

Keratosis, Actinic (21)  ·  Melanosis (3)  ·  Carcinoma, Basal Cell (2)  ·  Bowen's Disease (1)  ·  Carcinoma, Squamous Cell (1)  ·  Keratosis (1)  ·  Keratosis, Seborrheic (1)  ·  Warts (1)

Interventions

3-ingenyl angelate (22)  ·  Gels (9)

Countries

United States (19)  ·  Australia (18)  ·  New Zealand (1)

Top investigators

Eugene Bauer, MD (3)  ·  Greg Siller (3)  ·  Angela Smith (2)  ·  Janelle Katsamas (2)  ·  Jonothan S Dosik, MD (2)  ·  Peter Welburn, PhD (2)  ·  Arthur P Bertolino, MD (1)  ·  George Schmieder, DO (1)  ·  Jacqueline Morley (1)  ·  Jonathan Dosik, MD (1)  ·  Jonathon Dosik, MD (1)  ·  Lawrence Anderson, Dr (1)  ·  Lawrence Anderson, MD, F.A.C.P (1)  ·  Michael Jarratt, MD (1)  ·  Robert Rosen, Dr. (1)

Results publications

PMID 22417254, PMID 23553119, PMID 24765228, PMID 25584134