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A Randomized Trial of Broad Area ALA-PDT for Field Cancerization Mitigation in High-Risk Patients
Background:
The relationship between actinic keratoses (AKs) and nonmelanoma skin cancers (NMSCs) is well established. Patients with field cancerization are at high risk of developing new lesions. A treatment to interrupt new lesion formation or progression is required.
Objective:
To evaluate occurrence of AKs in high-risk patients after field aminolevulinic acid–photodynamic therapy (ALA–PDT).
Methods:
In this randomized, parallel-group, evaluator-blinded, 52-week study, patients with 4–15 facial AKs (N = 166) were random-ized (ALA 2x vs ALA 3x vs vehicle [VEH]-pooled [VEH 2x+VEH 3x], 1:1:1) to receive 2 or 3 PDT treatments (1-hour incubation) following cryotherapy at screening.
Results:
More ALA-treated patients than VEH-treated patients had no AKs at week 52 (ALA 2x, 36.0%, P=0.0102; ALA 3x, 37.5%, P=0.0089; VEH, 18.9%). Week 52 lesion recurrence rates were 7.7% (P=0.0004) and 6.1% (P<0.0001) for ALA 2x and ALA 3x, respec-tively, versus 15.5% for VEH. Therapy was well tolerated; no patient requested early termination of light treatment. ALA 3x reduced NMSC development versus VEH (5 vs 12 lesions, P=0.0014).
Conclusion:
2 or 3 ALA–PDT treatments with 1-hour incubation can significantly reduce occurrence of AKs after 1 year in patients at high risk of NMSC versus VEH–PDT (NCT02239679). J Drugs Dermatol. 2020;19(5):452-458. doi:10.36849/JDD.2020.4930.
Insights
Aminolevulinic acid–photodynamic therapy (ALA-PDT) significantly reduced actinic keratoses (AKs) in high-risk patients. Two or three ALA-PDT treatments effectively prevented new AK lesion development over one year.
Area of Science:
- Dermatology
- Oncology
- Photomedicine
Background:
- Actinic keratoses (AKs) are precursors to nonmelanoma skin cancers (NMSCs).
- Patients with field cancerization face a high risk of developing new skin lesions.
- Effective treatments are needed to prevent AK progression and new NMSC formation.
Purpose of the Study:
- To assess the efficacy of aminolevulinic acid–photodynamic therapy (ALA-PDT) in reducing AK occurrence.
- To evaluate the long-term impact of ALA-PDT on lesion recurrence in high-risk patients.
Main Methods:
- A randomized, evaluator-blinded, 52-week study involving 166 patients with facial AKs.
- Patients received either 2 or 3 ALA-PDT treatments or vehicle (VEH)-PDT, with a 1-hour incubation period.
- Cryotherapy was administered at screening prior to PDT sessions.
Main Results:
- Significantly fewer patients in ALA-PDT groups (36.0% for 2x, 37.5% for 3x) were AK-free at 52 weeks compared to the VEH group (18.9%).
- Lesion recurrence rates at 52 weeks were lower for ALA-PDT (7.7% and 6.1%) versus VEH (15.5%).
- ALA-PDT, particularly 3x, demonstrated a significant reduction in NMSC development (5 lesions) compared to VEH (12 lesions).
Conclusions:
- Two or three ALA-PDT treatments with a 1-hour incubation effectively reduce AK occurrence in high-risk patients over one year.
- ALA-PDT is a well-tolerated treatment option for managing AKs and preventing NMSC development.
- The study confirms ALA-PDT's role in managing field cancerization and reducing the burden of NMSCs.
