Actinic keratosis

Report Year
Trial Code
Trial Title
Clinicaltrials.gov
EudraCTno.
Source
2017
LP0084-1228
Biological Effects of LEO 43204 in Actinic Keratosis Assessed by Histopathology
N/A
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
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
N/A
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
N/A
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
N/A
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
N/A
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
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%
2012-004191-20
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
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
N/A
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
2011-001577-18
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
2011-001560-22
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)
N/A
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
N/A
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
N/A
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
N/A
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)
N/A
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)
N/A
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)
N/A
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)
N/A
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
N/A
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)
N/A
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
N/A
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)
N/A
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
N/A
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
N/A
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
N/A
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
N/A
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
Active Substance
N/A
LEO Pharma Product
N/A
Formulation
gel
Trial Phase
1
Population
adults
 
 
 

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