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Published on: May 27, 2022
Investigational drugs currently in phase II clinical trials for actinic keratosis
Flavia Lozzi1, Caterina Lanna1, Mauro Mazzeo1
1a Department of Systems Medicine , University of Rome "Tor Vergata" , Rome , Italy.
Introduction:
Actinic keratoses (AKs) are limited areas of irregular epidermal growth on a background of excessive solar exposure. The entire sun-damaged skin is considered a field of cancerization with multiple visible and subclinical lesions. AK management requires field-directed therapies to block lesion relapse and prevent squamous cell carcinoma (SCC).
Areas Covered:
In this review, we focused on phase II clinical trials for AKs, involving well-known agents and newer molecules such as proapoptotic drugs (VDA-1102, SR-T100, oleogel-S10, ICVT, eflornithine), immunomodulants (isotretinoin, tretinoin) and chemopreventive agents (nicotinamide, perillyl alcohol, liposomal T4N5). We used the website 'ClinicalTrials.Gov' as main reference. We selected and discussed completed and ongoing trials and analysed chemical structure and mechanism of action of the investigated molecules.
Expert Opinion:
AK therapy should be tailored on the patient's profile considering first of all the age and site of the AKs, which are relevant parameters for local immune response. The new molecules could be combined to obtain a synergic effect blocking the different steps of skin tumorigenesis. Phase II trials highlight a new therapeutic opportunity to block selectively cell proliferation regulators and work both on the field of cancerization and on the AKs currently present.
Insights
Actinic keratoses (AKs) management requires field-directed therapies to prevent squamous cell carcinoma (SCC). Phase II trials explore novel agents targeting cell proliferation for effective AK treatment and cancer prevention.
Area of Science:
- Dermatology
- Oncology
- Clinical Pharmacology
Background:
- Actinic keratoses (AKs) are epidermal growths on sun-damaged skin, representing a field of cancerization.
- Effective AK management necessitates field-directed therapies to prevent recurrence and squamous cell carcinoma (SCC).
Purpose of the Study:
- To review Phase II clinical trials for actinic keratoses.
- To analyze novel therapeutic agents, including proapoptotic drugs, immunomodulators, and chemopreventive agents.
Main Methods:
- Focused on Phase II clinical trials for AKs using 'ClinicalTrials.Gov' as the primary reference.
- Selected and discussed completed and ongoing trials, analyzing the chemical structure and mechanism of action of investigated molecules.
Main Results:
- Identified various agents like VDA-1102, SR-T100, oleogel-S10, ICVT, eflornithine, isotretinoin, tretinoin, nicotinamide, perillyl alcohol, and liposomal T4N5.
- Phase II trials indicate a therapeutic opportunity to selectively block cell proliferation regulators.
Conclusions:
- AK therapy should be individualized based on patient profile, age, and AK site, considering local immune response.
- Combining new molecules may offer synergistic effects to inhibit skin tumorigenesis.
- Phase II trials reveal new strategies for targeting the field of cancerization and existing AKs.
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