Phase 3 N=490 Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
Actinic Keratosis
Primary: Number of Participants With Complete Clearance of AK Lesions — 55; 41; 9 participants
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Phase 4 N=551 Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Keratosis
Primary: Number of Participants Who Experienced an Adverse Event — 472 participants
Phase 2 N=168 Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
Actinic Keratosis
Primary: Percentage of Participants With Complete Response of Actinic Keratosis — 43; 32 percentage of participants
Phase 3 N=479 Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)
Actinic Keratoses
Primary: Number of Participants With Complete Clearance of AK Lesions — 57; 49; 10 participants
Phase 4 N=30 Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Actinic Keratosis
Primary: Percent Change in the Number of Actinic Keratoses — -75 % change in number of actinic keratoses
Phase 3 N=26 Actinic Keratoses Treatment With Metvix® in Combination With Light
Actinic Keratoses
Primary: Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 — 19.6; 20.0 number of lesions — p=0.8460
Phase 2 N=21 Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
Actinic Keratosis
Primary: Number of Responders — 19 Participants
Phase 3 N=351 A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
Actinic Keratosis
Primary: Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions — 13; 54 percentage of participants — p=<0.0001
Phase 2 N=83 Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Actinic Keratosis
Primary: Complete Clearance Rate — 7; 9 Participants
Phase 3 N=60 Cryosurgery and Cream Combination for Actinic Keratosis
Actinic Keratosis
Primary: Number Participants With 100% Clearance — 12; 13 Participants
Phase 3 N=255 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
Actinic Keratoses
Primary: Patients With Complete Clearance of Actinic Keratosis (AKs) — 35; 6 Participants — p=<0.0001
Phase 3 N=203 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
Actinic Keratoses
Primary: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions — 42; 5 participants — p=0.001
Phase 2 N=33 Study of SOR007 Ointment for Actinic Keratosis
Actinic Keratosis
Primary: Number of Participants With Treatment Emergent Adverse Events — 2; 1; 3; 1 Participants
Phase 3 N=450 Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
Actinic Keratosis
Primary: Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation — 43; 9; 25; 5 participants — p=0.001
Phase 2 N=235 Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
Actinic Keratosis
Primary: Complete Clearance Rate — 14; 7; 13; 8 participants — p=0.0041
Phase 3 N=519 To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
Actinic Keratosis
Primary: Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator — 81; 76; 10 Participants
N/A N=20 Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
Actinic Keratoses
Primary: Efficacy of Tixel for Treatment of Actinic Keratosis — -90.4 percentage change
Phase 2 N=93 Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
Actinic Keratosis
Primary: Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 — -1.54; -1.34; -1.94 lesions — p=0.9518
Phase 2 N=165 The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Actinic Keratoses
Primary: Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance. — 22; 17; 19; 25 participants — p=0.60
N/A N=10 Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses
ACTINIC KERATOSES
Primary: Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline. — -72; -37.5 lesions
Phase 3 N=351 A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
Actinic Keratoses
Primary: Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions — 5; 44 percentage of participants — p=<0.0001
Phase 3 N=467 A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses
Actinic Keratosis
Primary: Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population — 12.4; 13.6; 4.8 percentage of participants — p=0.0702
Phase 2 N=100 ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Actinic Keratosis
Primary: Treatment Success at End of Study Visit — 66.7; 65.2; 76.0; 66.7 percentage of participants — p=0.799
Phase 2 N=16 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
Actinic Keratosis
Primary: Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels — NA; NA ng/mL
Phase 3 N=329 A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
Actinic Keratosis
Primary: Complete Clearance of AKs at Week 11 — 101; 80 participants
Phase 3 N=422 Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
Actinic Keratosis
Primary: Percentage of Participants With Treatment Success (Complete Clearance) at Week 6 — 33.9; 33.9; 3.3 percentage of participants — p=<0.0001
Phase 3 N=469 To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
Actinic Keratosis
Primary: Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions — 71; 71; 9 Participants
Phase 4 N=77 Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
Actinic Keratosis
Primary: CC Rate of AK Lesions in the Selected Treatment Area — 49; 8; 15; 1 Participants
Phase 4 N=27 Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Actinic Keratoses
Primary: Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment — -73.2; -62.0 Percent change
Phase 2 N=265 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)
Actinic Keratosis
Primary: Incidence of AEs Recorded Throughout the Study — 12; 12; 8; 11 participants