Actinic keratosis

 

Report Year

Trial Code

Trial Title

Clinicaltrials.gov

EudraCTno.

Source

2018

LP0105-1032

Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest

NCT02361216

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

3

Population

adults

2015

LP0105-1020

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

NCT01998984

N/A

Summary

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

2

Population

adults

2015

LP0105-1012

Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2 on the Chest in Subjects With Actinic Keratosis

NCT01820260

N/A

Summary

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1 & 2

Population

adults

2015

LP0084-1013

Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis

NCT01922050

N/A

Summary

Report Part 1

Report

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel & cream

Trial Phase

1 & 2

Population

adults

2017

LP0084-1228

Biological Effects of LEO 43204 in Actinic Keratosis Assessed by Histopathology

NCT02600598

N/A

Summary

Report

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2016

LP0041-1120

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

NCT02406014

2014-003218-98

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

4

Population

adults

2016

LP0084-1077

Pharmacokinetics of LEO 43204 gel in actinic keratosis administered under maximum use conditions

NCT02424305

N/A

Summary

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2016

LP0084-1148

Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively

NCT02305888

N/A

Summary

Report

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

2

Population

elderly

2015

LP0084-1015

Safety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on full balding scalp in subjects with actinic keratosis two consecutive days on approximately 250 cm2 on trunk and extremities in subjects with actinic keratosis

NCT02120456

N/A

 

Summary

Report Part 1

Report

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

2b

Population

adults

2015

LP0105-1034

Pharmacokinetics of ingenol mebutate gel in actinic keratosis under maximum use conditions

NCT02124239

N/A

Summary

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2015

LP0084-1014

Safety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on full balding scalp in subjects with actinic keratosis

NCT02100813

2014-000037-23

Summary

Report Part 1

Report

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

2b

Population

adults

2014

LP0041-62

Histological confirmation of clinical clearance of actinic keratoses following treatment with ingenol mebutate gel, 0.05%

NCT01892137

2012-004191-20

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

adults

2014

LP0041-22

Ingenol mebutate gel, 0.015% repeat use for multiple actinic keratoses on face and scalp

NCT01600014

2011-005018-13

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2013

LP0041-21

A sequential treatment regimen of cryotherapy and Picato® (ingenol mebutate) gel, 0.015% field therapy compared to cryotherapy alone for the treatment of actinic keratosis on the face and scalp

NCT01541553

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2012

LP0041-03

PEP005 gel – biological effects in actinic keratosis assessed by reflectance confocal microscopy

NCT01449513

2011-001577-18

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

adults

2012

LP0041-02

PEP005-gel – biological effects in actinic keratosis assessed by histology

NCT01387711

2011-001560-22

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

adults

2011

PEP005-30

A 12-month, long-term follow-up study of patients with actinic keratosis on the head (face or scalp) who have completed day 57 in studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

NCT00953732

N/A

Summary

Report

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

3

Population

adults

2011

PEP005-31

A 12-month, long-term follow-up study of patients with actinic keratosis on non-head areas (trunk and extremities) who have completed day 57 in study PEP005-020

NCT00952783

N/A

Summary

Report

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

3

Population

adults

2011

PEP005-032

A 12 month, long-term follow-up study of patients with actinic keratosis on non-head locations (trunk and extremities) who have completed day 57 in study PEP005-028

NCT00989313

N/A

Summary

Report

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2010

PEP005-014

Ingenol mebutate gel, 0.015% repeat use for multiple actinic keratoses on face and scalp

NCT00742391

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2010

PEP005-016

A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.015% in patients with actinic keratoses on the head (face or scalp)

NCT00916006

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2010

PEP005-025

A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.015% in patients with actinic keratoses on the head (face or scalp) (REGION-IIb)

NCT00915551

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2010

PEP005-028

A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.05% in patients with actinic keratoses on non-head locations (REGION-llb)

NCT00942604

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2010

PEP005-020

A multi-center, open-label study to evaluate the safety and efficacy of PEP005 (ingenol mebutate) gel, 0.05% in patients with actinic keratosis on non-head locations (trunk and extremities)

NCT00917306

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3b

Population

adults

2010

PEP005-017

A randomized, double-blind, vehicle-controlled 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

NCT02124237

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

2

Population

adults

2009

PEP005-015

A multicenter, randomized, double-blind, vehicle-controlled, dose-ranging study to evaluate the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 topical gel when used to treat actinic keratoses on the head (face or scalp)

NCT00700063

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

2

Population

adults

2009

PEP005-018

A multicenter, open-label study to examine the safety and toleration of 0.05% PEP005 topical gel in patients with actinic keratoses on the dorsum of the hand

NCT00544297

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

3

Population

adults

2009

PEP005-22

A multicenter, open-label, dose-area escalation, cohort study to evaluate the safety and tolerability of 0.05% PEP005 topical gel applied for two consecutive days to treatment area(s) of up to a total of 100 cm2 in patients with actinic keratoses on the extensor (dorsal aspect) forearm(s)

NCT00659893

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

adults

2009

PEP005-007

An open-label, multi-centre, dose-escalation, cohort study to determine the optimal tolerated regime and safety of PEP005 topical gel when applied to a 25 cm2 contiguous actinic keratoses treatment area on the face or face and scalp

NCT00427050

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

2a

Population

adults

2009

PEP005-013

A phase I, pharmacokinetic study to evaluate the extent of systemic absorption of PEP005, when applied as 0.05% PEP005 topical gel to a 100 cm2 (5 cm x 20 cm) contiguous actinic keratosis (AK) treatment area on extensor (dorsal aspect) forearm

NCT00544258

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

adults

2008

PEP005-001

A multi-center, randomized, double-blind, parallel-group, vehiclecontrolled study to determine the safety of PEP005 0.0025%, 0.01%, and 0.05% gel with two treatment schedules, day 1 and day 2 or day 1 and day 8 applications to actinic keratosis

NCT00107965

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

2a

Population

adults

2006

PEP005-004

An open-label, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 topical gel when applied on day 1 and day 2 to actinic keratoses on the shoulders, chest, back, or arms followed by a post-treatment follow-up period lasting at least four weeks

NCT00239135

N/A

Summary

Report

Active Substance

 ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

2a

Population

adults

2004

AGN204332004

A multicentre, double-blind, parallel, randomised, vehicle-controlled study of the safety of a single application of up to 0.2 ml of 0.01% PEP005 gel to actinic keratoses on the shoulders, chest, back and/or arms followed by a post-treatment follow-up period lasting at least 2 weeks

N/A

N/A

Summary

Report

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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