Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Home › Conditions › Actinic keratosis

Actinic keratosis

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Actinic keratosis

73 trials tracked for Actinic keratosis: 39 in phase 3 or 4 and 6 with published results. The most-cited published study has 402 citations.

73Trials tracked
39Phase 3 & 4
0Recruiting
6With published results
Phase distribution
Phase 4 8 Phase 3 31 Phase 2 26 Phase 1 4 Other / NA 4
  1. Phase 4 Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis Completed · 402 cited
  2. Phase 3 A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Completed · 163 cited
  3. Phase 3 Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis. Completed · 125 cited
  4. Phase 4 Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population Completed · 41 cited
  5. Phase 3 Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT) Completed · 6 cited
  6. Phase 4 Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015% Completed · 3 cited
Show 44 more trials
  1. Phase 4 Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy Completed
  2. Phase 4 Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Completed
  3. Phase 4 Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT) Completed
  4. Phase 4 Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses Completed
  5. Phase 4 A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses Completed
  6. Phase 3 Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp Completed
  7. Phase 3 Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy Completed
  8. Phase 3 Cryosurgery and Cream Combination for Actinic Keratosis Completed
  9. Phase 3 Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest Completed
  10. Phase 3 Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up Completed
  11. Phase 3 Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up Completed
  12. Phase 3 Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up Completed
  13. Phase 3 Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up Completed
  14. Phase 3 Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Completed
  15. Phase 3 Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis Completed
  16. Phase 3 A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses Completed
  17. Phase 3 An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis Completed
  18. Phase 3 A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis Completed
  19. Phase 3 A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis Completed
  20. Phase 3 Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Completed
  21. Phase 3 To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis Completed
  22. Phase 3 To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis Completed
  23. Phase 3 Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Completed
  24. Phase 3 A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis Completed
  25. Phase 3 Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer Completed
  26. Phase 3 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) Completed
  27. Phase 3 A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp Completed
  28. Phase 3 Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion Completed
  29. Phase 3 Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities Completed
  30. Phase 3 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) Completed
  31. Phase 3 Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery Completed
  32. Phase 3 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/Extremities Completed
  33. Phase 3 Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs) Completed
  34. Phase 2 Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses Completed
  35. Phase 2 Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp Completed
  36. Phase 2 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 Completed
  37. Phase 2 Study of SOR007 Ointment for Actinic Keratosis Completed
  38. Phase 2 Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively Completed
  39. Phase 2 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 Completed
  40. Phase 2 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 Keratosis Completed
  41. Phase 2 Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face Completed
  42. Phase 2 Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream Completed
  43. Phase 2 Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide Completed
  44. Phase 2 Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK) Completed

Showing the 50 most-cited and recently-updated of 73 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Actinic keratosis: what the trials found

Multiple topical and photodynamic therapies have been evaluated for the treatment of actinic keratosis (AK). Ingenol mebutate 0.015% demonstrated significant reductions in AK lesion counts, with reported decreases ranging from approximately 80% to 89% 2 and consistent efficacy across multiple trials [4, 8, 16, 17, 20, 21]. Specifically, one trial using a specialized delivery method for ingenol mebutate showed high statistical significance in primary efficacy outcomes 20.

Photodynamic therapy (PDT) and related agents show significant results in lesion reduction. Aminolevulinic Acid resulted in a 75% reduction in AK count 6, while Metvix PDT demonstrated a 95.5% reduction at week 18 and a 71% global reduction at month 15 7. A specific study on Metvix 160 mg/g cream showed significant differences in the number of new skin lesions at month 3 compared to a control group (p=0.0120) 13.

Other interventions include Imiquimod [18, 22], Tirbanibulin ointment [5, 14], and KX2-391 Ointment 1% 10. While some studies focused on patient satisfaction scores for Tirbanibulin 5 or local tolerability metrics 14, others confirmed consistent reductions in lesion counts with KX2-391 over a 57-day period 10. Biafine was also evaluated, showing a reduction in mean severity scores 9.

Recent results — preliminary, needs further review

  • * GZ21T was evaluated in a Phase 1 trial (N=41) for actinic keratosis 1.

For the clinician treating this condition

  • Ingenol mebutate 0.015% is supported by multiple trials showing significant percentage reductions in the number of AK lesions [2, 4, 8, 16, 17, 20, 21].
  • Photodynamic therapies (including Aminolevulinic Acid and Metvix) demonstrate high efficacy rates in reducing lesion counts [6, 7, 13].
  • KX2-391 Ointment 1% showed consistent reduction in lesion counts over a multi-month period with minimal serious adverse events reported 10.

AI synthesis of 10 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Oscillating abrasive device matches curettage and sandpaper for AK skin prep before ADL-PDT
Oncology RCT
Oscillating abrasive device matches curettage and sandpaper for AK skin prep before ADL-PDT New Tool Makes Sun Damage Treatment Faster
In 22 patients with actinic keratoses undergoing artificial daylight photodynamic therapy, a novel oscillating abrasive skin preparation dev…
This new device makes treating rough sun spots quicker and more comfortable without losing effectiveness.
Apr 16, 2026

Questions about Actinic keratosis

Does having actinic keratosis increase my risk of other skin cancers like Squamous Cell Carcinoma?

Yes, actinic keratosis is considered a precancerous lesion that increases your risk of developing squamous cell carcinoma (SCC).

Full answer →