LEO Pharma: Keratosis, Actinic trials

The registry lists 52 Keratosis, Actinic studies with LEO Pharma as lead sponsor. 0 are open to participants now and 23 have results posted.

Phase 1 18Phase 2 15Phase 3 14Phase 4 2No phase 8(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or ScalpTerminatedNCT03115476Phase 3Results posted
• Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-upCompletedNCT02549352Phase 3Results posted
• Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-upCompletedNCT02549339Phase 3Results posted
• Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-upCompletedNCT02547363Phase 3Results posted
• Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-upCompletedNCT02547233Phase 3Results posted
• Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or ChestCompletedNCT02361216Phase 3Results posted
• Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, RespectivelyCompletedNCT02305888Phase 2Results posted
• Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic KeratosisCompletedNCT02120456Phase 1/2Results posted
• Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic KeratosisCompletedNCT02100813Phase 1/2Results posted
• 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 KeratosisCompletedNCT01998984Phase 2Results posted
• Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%CompletedNCT01926496Phase 4Results posted
• A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic KeratosisCompletedNCT01922050Phase 1/2Results posted
• Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic KeratosisCompletedNCT01820260Phase 1/2Results posted
• A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/ExtremitiesCompletedNCT01787383Phase 3Results posted
• Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and ScalpCompletedNCT01600014Phase 3Results posted
• A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and ScalpCompletedNCT01541553Phase 3Results posted
• PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal MicroscopyCompletedNCT01449513Phase 1Results posted
• 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 LocationsCompletedNCT00942604Phase 3Results posted
• 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)CompletedNCT00916006Phase 3Results posted
• 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)CompletedNCT00915551Phase 3Results posted
• 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 KeratosisCompletedNCT00852137Phase 2Results posted
• 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 LocationsCompletedNCT00742391Phase 3Results posted
• 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)CompletedNCT00700063Phase 2Results posted
• TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients SatisfactionCompletedNCT04202445
• A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 GelCompletedNCT02650505Phase 1
• Biological Effects of LEO 43204 in Actinic KeratosisCompletedNCT02600598Phase 1
• The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical PracticeCompletedNCT02594436
• Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use ConditionsCompletedNCT02424305Phase 1
• PMS to Evaluate the Safety and Efficacy of Picato® GelCompletedNCT02421471
• Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or ScalpCompletedNCT02406014Phase 4
• The Real Life Topical Field Treatment of Actinic Keratosis StudyCompletedNCT02362152
• Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use ConditionsCompletedNCT02124239Phase 1
• Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 WeeksCompletedNCT02090465
• Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%CompletedNCT01892137Phase 1
• Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the ForearmCompletedNCT01803477Phase 1/2
• Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic KeratosisCompletedNCT01703078Phase 1
• PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by HistologyCompletedNCT01387711Phase 1
• PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy SubjectsCompletedNCT01302925Phase 1
• Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic KeratosisCompletedNCT01214564Phase 2
• 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 StudyCompletedNCT00989313
• A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 StudiesCompletedNCT00953732
• A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 StudyCompletedNCT00952783
• 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)CompletedNCT00917306Phase 3
• A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy VolunteersCompletedNCT00850811Phase 1
• A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy VolunteersCompletedNCT00850681Phase 1
• Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2CompletedNCT00659893Phase 1
• A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the HandCompletedNCT00544297Phase 2
• Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005CompletedNCT00544258Phase 1
• A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical GelCompletedNCT00427050Phase 2
• Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic KeratosesCompletedNCT00375739Phase 2
• Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical GelCompletedNCT00239135Phase 2
• Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic KeratosesCompletedNCT00107965Phase 2