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

Photodynamic Therapy (PDT) with 10% aminolevulinic acid (ALA) gel and narrow-band red light has been previously shown to be safe and effective for the treatment of squamous cell carcinoma in situ (SCCis) on the trunk and extremities. However, there is a paucity of data in the literature evaluating long-term disease recurrence after PDT. Hence, we performed a follow-up study in which nine of the original twelve patients from 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, indicating a long-term clearance rate of 88%. Cosmetic outcomes and patient satisfaction were favorable. Our data supports that red-light PDT with 10% ALA gel can achieve long-term clinical and histopathologic disease clearance and is a viable alternative to surgery for select SCCis.

Medical and aesthetic improvement of photodamaged skin by the combination of intense pulsed light and photodynamic therapy with 10% aminolevulinic acid hydrochloride gel.

OBJECTIVE: To evaluate the efficacy and safety of photodynamic therapy (PDT) with the novel 10% aminolevulinic acid (ALA) hydrochloride gel (10% ALA gel) and BF-RhodoLED® light (635 nm; 37 J/cm2 ) in combination with intense pulsed light (IPL) to augment the medical and aesthetic improvement of photodamaged skin of the décolleté. METHODS: This was a single-site prospective, randomized, intraindividual split chest pilot study with 20 female subjects with moderate to severe photodamage of the décolleté. Subjects were randomized to ALA-PDT + IPL to one split-side of the chest and ALA-PDT only to the contralateral side. Three blinded raters assessed aesthetic improvement using the global aesthetic improvement scale (GAIS). RESULTS: Eighteen subjects completed the study. Superior GAIS results were achieved on the ALA-PDT + IPL treatment side than on the ALA-PDT only treatment side (p < 0.001) after 24 weeks of follow-up. CONCLUSIONS: ALA-PDT using 10% ALA hydrochloride gel and BF-RhodoLED® light had superior rejuvenation effects on the décolleté when combined with IPL compared to ALA-PDT alone.

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.

BACKGROUND: Data evaluating the effectiveness of photodynamic therapy (PDT) with aminolevulinic acid (ALA) 10% nanoemulsion gel and red-light LED lamp for the treatment of squamous cell carcinoma in situ (SCCis) on the trunk and extremities is limited. Our study sought to investigate the safety and efficacy of utilizing ALA 10% gel with red-light lamp for the treatment of SCCis on the trunk and extremities. METHODS: A single center prospective study of 12 patients with biopsy proven SCCis underwent one or two cycles of red-light PDT with ALA 10 % gel and 3 hours incubation period. Each cycle consisted of two treatments approximately 10 days apart. All participants had a biopsy for histologic evaluation 4 weeks following the last treatment. RESULTS: All patients achieved clinical and histologic clearance following either one or two cycles at the 4-week post treatment follow up period. The majority of lesions were located on the extremities (n=10) with the remainder located on the trunk (n=2). The mean diameter of the lesions was 1.83 cm. Mild pain was noted in patients, with no interruption of treatment. CONCLUSIONS: Our study indicates that ALA 10% gel with a red-light lamp is a safe and effective treatment option for SCCis on the trunk and extremities.

Red light photodynamic therapy with BF-200 ALA showed superior efficacy in the treatment of actinic keratosis on the extremities, trunk, and neck in a vehicle-controlled phase III study.

BACKGROUND: Actinic keratoses (AK) may occur in all sun-exposed skin areas. Those occurring outside the head area are generally more resistant to treatment than those on the face. OBJECTIVE: To determine efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk, and neck with red light photodynamic therapy (PDT). METHODS: This phase III study had an intra-individual design with 50 patients in 6 centers in Germany. Each patient received a maximum of 2 field-directed PDTs. Clinical end points and 1-year follow-up results were recorded. RESULTS: BF-200 ALA was superior to the vehicle with respect to total lesion clearance rates (86.0% vs 32.9%; P < .0001) and patient complete clearance per patient's side (67.3% vs 12.2%, P < .0001). One-year overall lesion recurrence rate was 14.1% versus 27.4% (BF-200 ALA vs vehicle; P = .0068). Patients were more satisfied by the cosmetic outcome of BF-200 ALA/PDT than the vehicle/PDT. Adverse events were consistent with the known safety profile of BF-200 ALA/PDT. LIMITATIONS: Small number of severe lesions; limited sample size; unbalanced but representative distribution of AK. CONCLUSION: BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.

Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel and Red Light for the Treatment of Actinic Keratosis, Nonmelanoma Skin Cancers, and Acne: Current Evidence and Best Practices.

Photodynamic therapy (PDT) can be an effective treatment for actinic keratosis (AK) as well as selected non-melanoma skin cancers (NMSCs), such as Bowen's disease and superficial basal cell carcinoma. PDT has also demonstrated effectiveness in the management of acne vulgaris. Results from controlled clinical trials have shown the safety and efficacy of PDT for these conditions with the use of different photosensitizers and a wide range of light sources. PDT has been employed effectively as monotherapy and in combination with other topicals and alternate light or laser energy therapies. This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for AKs, NMSC, and acne. Here, information from clinical guidelines and a summary of supporting evidence is provided for each cutaneous condition. The authors also provide detailed guidance for employing ALA 10% gel, a photosensitizer precursor, for each of these applications.

Regression Analysis of Protoporphyrin IX Measurements Obtained During Dermatological Photodynamic Therapy.

Photodynamic therapy (PDT) is a light activated drug therapy that can be used to treat a number of dermatological cancers and precancers. Improvement of efficacy is required to widen its application. Clinical protoporphyrin IX (PpIX) fluorescence data were obtained using a pre-validated, non-invasive imaging system during routine methyl aminolevulinate (MAL)-PDT treatment of 172 patients with licensed dermatological indications (37.2% actinic keratosis, 27.3% superficial basal cell carcinoma and 35.5% Bowen's disease). Linear and logistic regressions were employed to model any relationships between variables that may have affected PpIX accumulation and/or PpIX photobleaching during irradiation and thus clinical outcome at three months. Patient age was found to be associated with lower PpIX accumulation/photobleaching, however only a reduction in PpIX photobleaching appeared to consistently adversely affect treatment efficacy. Clinical clearance was reduced in lesions located on the limbs, hands and feet with lower PpIX accumulation and subsequent photobleaching adversely affecting the outcome achieved. If air cooling pain relief was employed during light irradiation, PpIX photobleaching was lower and this resulted in an approximate three-fold reduction in the likelihood of achieving clinical clearance. PpIX photobleaching during the first treatment was concluded to be an excellent predictor of clinical outcome across all lesion types.