Long-term follow up of ALA 10% gel and red-light photodynamic therapy for the treatment of squamous cell carcinoma in situ


We have previously demonstrated that amino-

levulinic acid (ALA) 10% gel with red-light PDT is

safe and effective for the treatment of squamous

cell carcinoma in situ (SCCis) of the trunk and

extremities.1 We performed a follow-up study in

which nine of the original twelve patients in our pilot

study returned 29 – 40 months after their last PDT

treatment. All patients were clinically clear of

disease and only one of seven patients biopsied

had residual disease. Our data supports that 10%

ALA gel with red-light PDT can achieve long-term

clinical and histopathologic disease clearance and is

a viable alternative to surgery for select SCCis.

Synopsis

• Nine out of the original twelve patients in the pilot

study returned for evaluation at least one year

after their last PDT treatment

• Clinical assessment and possible punch biopsy

were performed to evaluate clinical and

histopathologic recurrence of SCCis

• Cosmetic outcomes (rated 1-4) per the patient

and investigator as well as patient satisfaction

with PDT treatment were evaluated

Methods

ALA 10% gel with red-light PDT is effective to treat

and induce long-term remission of SCCis of the

trunk and extremities.

Conclusion

To determine the long-term efficacy of ALA 10% gel

with red-light PDT for the treatment of SCCis of the

trunk and extremities in immuno-competent patients.

Objective

• All patients were clinically clear of disease

• Seven of the eight patients* who underwent a
biopsy were clear of disease, indicating a long-term
clearance rate of 88%

• Lesions that recurred were initially > 2 cm

• Cosmetic assessment evaluated by the patient was
congruent with that of the investigator, which was
good to excellent

• Seven out of nine patients were satisfied with PDT

Results

1. Cervantes JA, Zeitouni NC. Photodynamic therapy utilizing 10% ALA nano-emulsion gel and red-light for the treatment of squamous cell 

carcinoma in-situ on the trunk and extremities: Pilot study and literature update. Photodiagnosis Photodyn Ther. 2021;35:102358

* one of the patients that declined biopsy had a previous 

negative biopsy performed 6 months after last PDT

Long-term Follow Up of ALA 10% Gel and Red-Light Photodynamic 
Therapy for the Treatment of Squamous Cell Carcinoma In Situ 

Paul Shim1, Nathalie Zeitouni MD1, 2
1 University of Arizona College of Medicine, Phoenix, Arizona

2 Medical Dermatology Specialists, Phoenix, Arizona

This study was investigator-initiated and funded by Biofrontera, Inc.