Skip to main content

Actinic Keratoses

14
Pipeline Programs
10
Companies
24
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
1
0
6
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
1100%
+ 18 programs with unclassified modality

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Galderma
GaldermaTX - Dallas
6 programs
4
1
Methyl Aminolaevulinate 16% CreamPhase 41 trial
MAL 16.8% creamPhase 31 trial
Metvix and natural daylight PDTPhase 31 trial
Metvix®Phase 31 trial
NDL-PDTPhase 31 trial
+1 more programs
Active Trials
NCT05725213Completed224Est. Oct 2023
NCT04085367Completed557Est. Apr 2021
NCT01475071Completed100Est. Mar 2013
+3 more trials
Biofrontera
BiofronteraGermany - Leverkusen
4 programs
2
1
1
Ameluz 10% Topical GelPhase 41 trial
BF-200 ALA and red light LED lampPhase 31 trial
AmeluzPhase 11 trial
BF-200 ALA and red light LED lampPhase 11 trial
Active Trials
NCT07053852Completed10Est. Dec 2025
NCT04319159Completed48Est. Oct 2020
NCT05662202Active Not Recruiting172Est. Jun 2026
+1 more trials
Leo Pharma
Leo PharmaDenmark - Ballerup
2 programs
1
1
Ingenol MebutatePhase 41 trial
ingenol mebutate 0.015%Phase 11 trial
Active Trials
NCT02411851Completed20Est. Jun 2016
NCT02251652Completed16Est. Aug 2015
Amryt Pharma
Amryt PharmaUK - London
1 program
1
oleogel-S10Phase 35 trials
Active Trials
NCT03068780Completed223Est. May 2022
NCT01807650Completed112Est. Sep 2014
NCT01657292Completed61Est. Jul 2014
+2 more trials
Clinuvel Pharmaceuticals
Clinuvel PharmaceuticalsAustralia - Melbourne
1 program
1
AfamelanotidePhase 2Peptide1 trial
Active Trials
NCT00829192Unknown200Est. Aug 2012
Coegin Pharma
Coegin PharmaSweden - Lund
1 program
1
AVX001Phase 1/21 trial
Active Trials
NCT05164393Unknown60Est. Mar 2022
Fitzpatrick Company
Fitzpatrick CompanyON - Waterloo
1 program
Antihistamine Cetirizine HydrochlorideN/A1 trial
Active Trials
NCT02451579Completed20Est. Jan 2017
ME Therapeutics
ME TherapeuticsNEW YORK, NY
1 program
AVX001PHASE_1_2
Pierre Fabre
Pierre FabreFrance - Aignan
1 program
5-fluorouracil 4%PHASE_41 trial
Active Trials
NCT04875026Completed146Est. Jan 2022
Rigel Pharmaceuticals
Rigel PharmaceuticalsSOUTH SAN FRANCISCO, CA
1 program
imiquimod 5% creamPHASE_41 trial
Active Trials
NCT00774787Completed27Est. Mar 2010

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
BiofronteraAmeluz 10% Topical Gel
Pierre Fabre5-fluorouracil 4%
GaldermaMethyl Aminolaevulinate 16% Cream
Leo PharmaIngenol Mebutate
Rigel Pharmaceuticalsimiquimod 5% cream
BiofronteraBF-200 ALA and red light LED lamp
GaldermaMAL 16.8% cream
Amryt Pharmaoleogel-S10
GaldermaMetvix®
GaldermaNDL-PDT
Amryt Pharmaoleogel-S10
Amryt Pharmaoleogel-S10
Amryt Pharmaoleogel-S10
GaldermaMetvix and natural daylight PDT
Amryt Pharmaoleogel-S10

Showing 15 of 24 trials with date data

Clinical Trials (24)

Total enrollment: 2,549 patients across 24 trials

NCT06745999BiofronteraAmeluz 10% Topical Gel

Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face

Start: May 2023Est. completion: Jun 202540 patients
Phase 4Unknown
NCT04875026Pierre Fabre5-fluorouracil 4%

Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

Start: Feb 2021Est. completion: Jan 2022146 patients
Phase 4Completed
NCT03511326GaldermaMethyl Aminolaevulinate 16% Cream

PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

Start: Jun 2017Est. completion: Nov 201750 patients
Phase 4Completed
NCT02251652Leo PharmaIngenol Mebutate

Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

Start: Apr 2013Est. completion: Aug 201516 patients
Phase 4Completed

Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses

Start: Oct 2008Est. completion: Mar 201027 patients
Phase 4Completed
NCT05662202BiofronteraBF-200 ALA and red light LED lamp

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp

Start: Dec 2022Est. completion: Jun 2026172 patients
Phase 3Active Not Recruiting
NCT04085367GaldermaMAL 16.8% cream

Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face

Start: Sep 2019Est. completion: Apr 2021557 patients
Phase 3Completed

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Start: Mar 2017Est. completion: May 2022223 patients
Phase 3Completed

Actinic Keratoses Treatment With Metvix® in Combination With Light

Start: Mar 2015Est. completion: Jun 201826 patients
Phase 3Completed

Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

Start: Jul 2013Est. completion: Mar 2014131 patients
Phase 3Completed

Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)

Start: Mar 2013Est. completion: Sep 2014112 patients
Phase 3Completed

Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

Start: Aug 2012Est. completion: Jul 201461 patients
Phase 3Completed

Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)

Start: Aug 2012Est. completion: Sep 2014107 patients
Phase 3Completed
NCT01475071GaldermaMetvix and natural daylight PDT

Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Start: Mar 2012Est. completion: Mar 2013100 patients
Phase 3Completed

Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

Start: Nov 2010Est. completion: Jun 201110 patients
Phase 2Completed

Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites

Start: Apr 2010Est. completion: Nov 201024 patients
Phase 2Completed

The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

Start: Oct 2008Est. completion: Nov 2010165 patients
Phase 2Completed

Phase II AK Study in Organ Transplant Patients

Start: Nov 2007Est. completion: Aug 2012200 patients
Phase 2Unknown

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

Start: Nov 2021Est. completion: Mar 202260 patients
Phase 1/2Unknown

Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage

Start: Jun 2025Est. completion: Dec 202510 patients
Phase 1Completed
NCT04319159BiofronteraBF-200 ALA and red light LED lamp

Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)

Start: Mar 2020Est. completion: Oct 202048 patients
Phase 1Completed
NCT02411851Leo Pharmaingenol mebutate 0.015%

Treatment of Actinic Keratoses (AK) on the Face

Start: Mar 2015Est. completion: Jun 201620 patients
Phase 1Completed
NCT05725213GaldermaMetvix® 160 mg/g Creme

ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis

Start: Nov 2022Est. completion: Oct 2023224 patients
N/ACompleted
NCT02451579Fitzpatrick CompanyAntihistamine Cetirizine Hydrochloride

A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

Start: Feb 2015Est. completion: Jan 201720 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs, potential near-term approvals
10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.