The burning truth about light therapy: a retrospective analysis of the MAUDE database on UV phototherapy and photodynamic therapy complications 2013-2023.

INTRODUCTION: Phototherapy and photodynamic therapy (PDT) are ultraviolet light (UV) based therapies for patients with skin diseases, and are sometimes associated with potential adverse events (AE)s, including erythema, pain, pruritus, burns, and photoaging. METHODS: We investigated UV phototherapy and PDT safety using the United States (US) Food and Drug Administration's (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database, including medical device reports (MDR)s informed by voluntary and obligatory reporters since 1991, was searched for AEs associated with UV phototherapy and PDT 1/1/91-3/1/23. RESULTS: There were 59 UV phototherapy and 33 PDT related MDRs. Burns were the most common AE type for both phototherapy and PDT. The majority of phototherapy AEs occurred during 2021 (52.3%), and were significantly more likely to occur at home than in the clinic. Overall, 76.1% of MDRs associated with home light boxes were prescribed by online retailers, most of the MDRs (59.3%) mentioned that it is prohibited to sell phototherapy devices not prescribed by physicians, and only 8.5% noted poorly written home light box instructions. DISCUSSION: The COVID-19 pandemic prohibited in-person light treatments, and social distancing requirements may have resulted in increased frequency of home-based light treatments. Hence, while at home treatment may be easier and more accessible, in-office physician supervised UV treatments are associated with less frequent AEs. Moreover, some phototherapy MDRs reported poorly written instructions accompanying the home light box, and some PDT MDRs documented patients receiving inadequate education regarding the procedure. With the rise of at-home treatment options and the ease of obtaining devices on the internet, it is physicians' duty to advise patients against self-treating with home light boxes without prescribed treatment regimens and educate patients that are considering home phototherapy to ensure safer patient experiences.

Bath psoralen plus ultraviolet-A photochemotherapy for chronic graft-versus-host disease: a retrospective cohort study.

BACKGROUND: Chronic graft-versus-host disease is a severe complication of allogeneic stem cell and bone marrow transplantation. First-line immunosuppressive agents, such as steroids, are used to prevent this disease; however, they have multiple side effects. Therefore, bath psoralen plus ultraviolet-A (PUVA) is an alternative second-line treatment. This study aimed to evaluate the clinical efficacy of bath PUVA for managing chronic graft-versus-host disease. METHODS: This retrospective, case-control study included 14 patients with extensive cutaneous chronic graft-versus-host disease, resistant to systemic corticosteroid, treated with bath PUVA. Major and partial responses were defined as clinical improvements of >70% and 50-70%, respectively. We analyzed the graft-versus-host disease clinical presentation and timing after allogeneic stem cell and bone marrow transplantation, bath PUVA doses, background diseases, additional treatments, and adverse effects. RESULTS: We observed eight major (three lichenoid and five sclerodermatoid) and six partial (three lichenoid and three sclerodermatoid) responses after a mean of 28 treatment sessions. After 6 to 25 months, four of the eight patients with sclerodermatoid lesions and all those with lichenoid lesions experienced relapse but responded to additional treatment cycles. CONCLUSIONS: Bath PUVA is well-tolerated and effective for extensive cutaneous chronic graft-versus-host disease. It allows rapid tapering of adjuvant immunosuppressants; however, most patients require prolonged maintenance phototherapy.

A Randomized Split-Face Study of Photodynamic Therapy With St. John's Wort and Indole-3-Acetic Acid for the Treatment of Acne.

BACKGROUND: St. John's wort (SJW) contains hypericin, a powerful photosensitizer with antimicrobial and anti-inflammatory activities. OBJECTIVE: To compare the efficacy and safety of SJW-photodynamic therapy (PDT) with that of indole-3-acetic acid (IAA)-PDT for the treatment of acne and investigate the skin rejuvenating effects of SJW-PDT. MATERIALS AND METHODS: In vitro experiments were conducted to examine the generation of reactive oxygen species and the antimicrobial effects of SJW-PDT. In the prospective, double-blind, split-face, randomized study, 31 patients with facial acne were treated with SJW or IAA with simultaneous illumination of red light and green light. RESULTS: SJW produces free radicals with visible light irradiation, and the growth of Cutibacterium acnes and Staphylococcus aureus is significantly suppressed. One week after the last treatment, the acne lesion counts were significantly decreased in both groups (56.5% reduction in SJW, p < .001 vs 57.0% in IAA, p < .001). Significant reductions in sebum secretion, erythema index, roughness, and wrinkles were observed in both groups after the treatment. No side effects were observed. CONCLUSION: SJW-PDT is a simple, safe, and effective treatment option for acne that is also beneficial for skin rejuvenation.

Pharmacological Agents Used in the Prevention and Treatment of Actinic Keratosis: A Review.

Actinic keratosis (AK) is among the most commonly diagnosed skin diseases with potentially life-threatening repercussions if left untreated. Usage of pharmacologic agents represents one of many therapeutic strategies that can be used to help manage these lesions. Ongoing research into these compounds continues to change our clinical understanding as to which agents most benefit particular patient populations. Indeed, factors such as past personal medical history, lesion location and tolerability of therapy only represent a few considerations that clinicians must account for when prescribing appropriate treatment. This review focuses on specific drugs used in either the prevention or treatment of AKs. Nicotinamide, acitretin and topical 5-fluorouracil (5-FU) continue to be used with fidelity in the chemoprevention of actinic keratosis, although some uncertainty persists in regard to which agents should be used in immunocompetent vs. immunodeficient/immunosuppressed patients. Topical 5-FU, including combination formulations with either calcipotriol or salicylic acid, as well as imiquimod, diclofenac and photodynamic light therapy are all accepted treatment strategies employed to target and eliminate AKs. Five percent of 5-FU is regarded as the most effective therapy in the condition, although the literature has conflictingly shown that lower concentrations of the drug might also be as effective. Topical diclofenac (3%) appears to be less efficacious than 5% 5-FU, 3.75-5% imiquimod and photodynamic light therapy despite its favorable side effect profile. Finally, traditional photodynamic light therapy, while painful, appears to be of higher efficacy in comparison to its more tolerable counterpart, daylight phototherapy.

PUVA therapy in persistent cutaneous histiocytosis: Case report and literature review.

BACKGROUND: Cutaneous and mucocutaneous histiocytosis (group C) comprise a wide variety of entities affecting skin and/or mucosae. Although they are considered as reactive proliferations, their exact pathophysiology remains unknown and, therefore, they lack a specific treatment. AIMS: The aim of this study is to review the evidence on cases of histiocytosis treated with UVB and/or UVA and to report a new case of relapsing group C histiocytosis that has been successfully treated with PUVA therapy. MATERIALS & METHODS: We have conducted a review of the literature published over the last 40 years on the treatment of histiocytosis with phototherapy in the online PubMed database. We also describe a new case of successful treatment of histiocytosis with PUVA therapy. RESULTS: Our patient was a 27-year-old man with persistent outbreaks of cutaneous histiocytosis over the previous 8 years. He responded successfully to PUVA therapy, and no relapse has been detected after one year of follow-up. DISCUSSION: Self-involution is usual in group C histiocytosis, so conservative management is usually the first approach. Relapsing cases pose a therapeutic challenge. Reported treatment options for these patients include isotretinoin, cryotherapy, immunosuppressants, low-dose chemotherapy, CO2 laser, radiotherapy, and surgery. Phototherapy and photochemotherapy have been used in a small number of patients with considerable success. The main limitation to provide firm recommendations on histiocytosis therapy is the absence of solid evidence, as the articles published are mainly case reports with a short follow-up. In our patient, despite the short follow-up we have considered photochemotherapy to be effective since no spontaneous remission had been achieved in the previous 8 years. CONCLUSION: PUVA therapy could be a safe and effective option to treat persistent cutaneous manifestations in patients with histiocytosis, although more evidence is required to support this statement.

Combined therapy of 5-aminolevulinic acid photodynamic therapy and intense pulsed light for rosacea.

Rosacea is difficult to treat. Therefore, new alternative modalities are necessary to demonstrate. The present study was conducted to assess the efficacy and safety of the combined therapy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) and intense pulsed light (IPL) for rosacea to provide a new treatment option for rosacea. The study was conducted from November 2017 to April 2019 at the Department of Dermatology, The First Hospital of China Medical University. Patients aged 18-65 years and diagnosed clinically as erythematotelangiectatic (ET) or papulopustular (PP) rosacea were enrolled. Three times of ALA-PDT at 10 days interval followed by 3 times of IPL at 3-4 weeks interval were defined as 1 session and applied to the whole face of each patient. ALA-PDT: 5% ALA, red light (fluency dose 60-100 mW/cm2, 20 min); IPL: 560/590/640 nm, double/triple-pulse mode, pulse width 3.0 to 4.5 ms, delay time 30-40 ms, energy fluency 14-17 J/cm2. Ten patients were enrolled in the study. Among them, 4 patients received only 1 session, while 6 patients received 2 sessions. After all treatments, 50% of patients achieved 75-100% improvement, and 30% achieved 50-75% improvement. Forty percent of patients were graded very satisfaction and 30% graded moderate satisfaction. All noninvasive measurements showed no significant differences among all time points (p > 0.05). The side effects were pain, burning sensation, itching, erythema, desquamation, slight edema, slight exudation, and hyperpigmentation. All of which were tolerable and recovered in a few days. The combined therapy of ALA-PDT and IPL showed an effective option for rosacea with a safety profile.

Half-fluence Photodynamic Therapy for Central Serous Chorioretinopathy in a Patient Receiving Corticosteroids for Behçet's Uveitis

Corticosteroid-induced central serous chorioretinopathy (CSCR) has been reported to develop in many intraocular inflammatory diseases and usually resolves spontaneously after discontinuation of corticosteroids. Patients without any improvement may require alternative therapies. In this case report, we present the case of a 35-year-old man with Behçet's disease who had complaints of decreased vision due to CSCR in his left eye while using systemic corticosteroids along with cyclosporine and azathioprine. Half-fluence photodynamic therapy (PDT) was performed because the CSCR did not regress despite discontinuation of systemic corticosteroids. After treatment, his visual acuity increased with complete resolution of the subfoveal fluid. Half-fluence PDT seems to be an effective and safe treatment for patients who develop acute CSCR while under systemic or local corticosteroid therapy for intraocular inflammatory diseases such as Behçet's uveitis and do not improve despite steroid discontinuation.

Photodynamic Therapy for Colorectal Cancer: A Systematic Review of Clinical Research.

BACKGROUND: Photodynamic therapy (PDT) is a therapeutic modality that can be used to ablate tumors using the localized generation of reactive oxygen species by combining a photosensitizer, light, and molecular oxygen. This modality holds promise as an adjunctive therapy in the management of colorectal cancer and could be incorporated into neoadjuvant treatment plans under the auspices of prospective clinical trials. METHODS: We conducted a search of primary literature published until January 2021, based on PRISMA guidelines. Primary clinical studies of PDT for the management of colorectal cancer were included. Screening, inclusion, quality assessment, and data collection were performed in duplicate. Analyses were descriptive or thematic. RESULTS: Nineteen studies were included, most of which were case series. The total number of patients reported to have received PDT for colorectal cancer was 137, almost all of whom received PDT with palliative intent. The most common photosensitizer was hematoporphyin derivative or Photofrin. The light dose used varied from 32 J/cm2 to 500 J/cm2. Complete tumor response (cure) was reported in 40%, with partial response reported in 43.2%. Symptomatic improvement was reported in 51.9% of patients. In total, 32 complications were reported, the most common of which was a skin photosensitivity reaction. CONCLUSIONS: PDT for the management of colorectal cancer has not been well studied, despite promising results in early clinical case series. New, well designed, prospective clinical trials are required to establish and define the role of PDT in the management of colorectal cancer.

Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial.

BACKGROUND: In mouse models of skin cancer, high-dose oral vitamin D3 (VD3; cholecalciferol) combined with photodynamic therapy (PDT) can improve the clearance of squamous precancers (actinic keratoses [AKs]). OBJECTIVE: To determine whether oral VD3 can improve the clinical efficacy of a painless PDT regimen in humans with AK. METHODS: The baseline lesion counts and serum 25-hydroxyvitamin D3 levels were determined. In group 1, 29 patients underwent gentle debridement and 15-minute aminolevulinic acid preincubation with blue light (30 minutes; 20 J/cm2). In group 2, 29 patients took oral VD3 (10,000 IU daily for 5 or 14 days) prior to debridement and PDT. Lesion clearance was assessed at 3 to 6 months. RESULTS: In group 1, the mean clearance rates of facial AK were lower in patients with VD3 deficiency (25-hydroxyvitamin D3 level < 31 ng/dL; clearance rate, 40.9% ± 42%) than in patients with normal 25-hydroxyvitamin D3 levels (62.6% ± 14.2%). High-dose VD3 supplementation (group 2) significantly improved the overall AK lesion response (72.5% ± 13.6%) compared with that in group 1 (54.4% ± 22.8%). No differences in side effects were noted. LIMITATIONS: Nonrandomized trial design (interventional cohort matched to registry-based controls). CONCLUSIONS: Oral VD3 pretreatment significantly improves AK clinical responses to PDT. The regimen appears promising and well tolerated.

Diffuse Lamellar Keratitis in a Patient Undergoing Collagen Corneal Cross-Linking 18 Years After Laser In Situ Keratomileusis Surgery.

PURPOSE: To report a case of diffuse lamellar keratitis (DLK) after corneal collagen cross-linking in an eye with a remote history of laser in situ keratomileusis (LASIK) surgery. METHODS: This is a case report and literature review. RESULTS: This report describes the development of unilateral stage IV DLK in a patient who underwent bilateral corneal cross-linking for corneal ectasia 18 years after LASIK surgery. The patient was treated with high-dose topical steroids that were tapered over 1 month and multiple flap lifts. The ultimate best-corrected visual outcome was 20/60. CONCLUSIONS: DLK is a potential sight-threatening complication of refractive surgery that can occur at any time in the postoperative period, even years after the procedure. Undergoing a subsequent corneal procedure that may disrupt or promote inflammation within the surgical flap-stromal interface, such as corneal collagen cross-linking, is a recognized risk factor for the development of DLK. This case suggests that patients with any history of LASIK surgery undergoing corneal cross-linking or other lamellar corneal surgeries may benefit from closer follow-up (eg, daily) than patients with no history of LASIK.

Tailoring photosensitive ROS for advanced photodynamic therapy.

Photodynamic therapy (PDT) has been considered a noninvasive and cost-effective modality for tumor treatment. However, the complexity of tumor microenvironments poses challenges to the implementation of traditional PDT. Here, we review recent advances in PDT to resolve the current problems. Major breakthroughs in PDTs are enabling significant progress in molecular medicine and are interconnected with innovative strategies based on smart bio/nanomaterials or therapeutic insights. We focus on newly developed PDT strategies designed by tailoring photosensitive reactive oxygen species generation, which include the use of proteinaceous photosensitizers, self-illumination, or oxygen-independent approaches. While these updated PDT platforms are expected to enable major advances in cancer treatment, addressing future challenges related to biosafety and target specificity is discussed throughout as a necessary goal to expand the usefulness of PDT.

Contrasting the efficacy of pulsed dye laser and photodynamic methylene blue nanoemulgel therapy in treating acne vulgaris.

The treatment of acne remains a challenge for dermatologists. A variety of conventional therapies are available for acne treatment such as topical and systemic medications. Although many of these traditional acne treatments are effective, the wide-spread nature of the disease and its sometimes resistant nature delineate the need for alternative therapies. Therefore, over the past decade, phototherapy has been introduced for the treatment of acne, such as pulsed dye lasers (PDLs) and photodynamic therapy (PDT). The aim of this study was to compare the safety and efficacy of PDL and methylene blue-mediated photodynamic therapy (MB-PDT) in the treatment of mild to moderate acne. Split-face clinical trial including fifteen patients presenting with mild to moderate acne were treated with 585 nm PDL on the right side of the face and MB-PDT with 665-nm diode laser on the left side. The photosensitizer MB was prepared in nanoemulgel formulation, and the treatment was carried out for three sessions maximum at 2-weeks intervals. Results revealed that both PDL and MB-PDT were effective therapies in the treatment of acne, as manifested by the reduction of inflammatory and non-inflammatory lesions throughout the treatment period. However, the latter therapy was proven more potent in the reduction of acne severity, and in terms of patients' tolerance. Therefore, it can be concluded that MB in the nanoemulgel form is a promising treatment approach for acne, and can be further experimented in the treatment of other dermatological diseases.

Safe and effective use of phototherapy and photochemotherapy in the treatment of psoriasis.

Psoriasis is a chronic, multisystem inflammatory disease, predominantly affecting the skin and joints, which is present in 2-3% of the world's population. Narrow band ultraviolet B (NB-UVB) and Psoralen + ultraviolet A (PUVA) are recognised, effective and, in the case of UVB, economical second-line treatments for psoriasis where topical therapies fail to control the disease or are an impracticable option due to the extent of skin involvement. This article examines the history of phototherapy and photochemotherapy and looks at current phototherapy treatments used for psoriasis. It discusses side effects of treatment and regimens that can be followed to increase effectiveness of treatment and minimise risks. The role of the nurse phototherapist is also discussed.

A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination.

BACKGROUND: Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination. OBJECTIVE: To compare a conventional regimen (1 hour of 5-aminolevulinic acid [ALA] preincubation, followed by blue light) versus a new modified regimen in which blue light is started immediately after ALA application. METHODS: A clinical trial with a bilaterally controlled, intrapatient study design was conducted with 23 patients. Topical 20% ALA was applied to the entire face and/or scalp. On 1 side of the body, blue light was started immediately and continued for either 30, 45, or 60 minutes (simultaneous PDT). On the contralateral side, the blue light began 1 hour after ALA application and lasted 1000 seconds (conventional PDT). Pain was evaluated on a scale from 0 to 10. Actinic keratosis lesion counts were determined by clinical examination and photography. RESULTS: All patients experienced significantly less pain during simultaneous illumination than during the conventional regimen. At 3 months after treatment, lesion clearance was nearly identical on the 2 sides, as determined by statistical testing of noninferiority ± 15% margin. LIMITATIONS: Although bilaterally controlled, the study was relatively small. Additional studies are recommended. CONCLUSION: The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.

The feasibility of using Saffron to reduce the photosensitivity reaction of selected photosensitizers using red blood cells and staphylococcusAureus bacteria as targets.

BACKGROUND: The photosensitivity reaction which appears after a Photodynamic therapy treatment session is a challenge that needs further investigation. The goal of this research is to evaluate the possibility of using saffron to reduce or control this photosensitivity reaction and to present mathematical modeling of the cell survival curves and their dependency on saffron concentration. METHODS: Red blood cells (RBC) and Staphylococcus aureus Bacteria (STB) were used as targets in this study. The Photosensitivity of Rose Bengali, Methylene Blue, and Photofrin independently and incorporated with saffron was investigated for continued irradiation at different Saffron concentrations. Gompertz's function was used to fit the survival curve parameters. The 50% cell survival rate was fit to an empirical formula based on Saffron concentrations. RESULTS: Saffron inhibits the photosensitivity reaction of the three photosensitizers and causes a significant increase in the 50% survival rate time (t50) for RBC`s and STB. Saffron didn't show phototoxicity when incubated alone with RBC`s and STB. The survival curve parameters of the RBCs and STB showed a good fit to the Gompertz function. Saffron concentration is related to the RBC`s t50 based on power dependency of 0.56, 0.38 and 0.31 for Photofrin, Methylene Blue and Rose Bengali respectively and 0.1 on STB for Rose Bengali. CONCLUSION: Saffron can efficiently be used to reduce the photosensitivity reaction of Photosensitizers after a PDT treatment session. Gompertz function was found to be an appropriate mathematical model for survival rate curves. The t50 and the saffron concentration are well related through a power dependence empirical formula.

Synergistic effect of photodynamic therapy at 400 nm and doxycycline against Helicobacter pylori.

Aim: The objective of this study was to investigate the possible synergy between doxycycline and photodynamic therapy against Helicobacter pylori and to evaluate the possible side effects on adenocarcinoma gastric cells with and without protoporphyrin IX. Materials & methods: Three H. pylori strains (ATCC 700392, 43504 and 49503) were grown on solid medium either with, or without, doxycycline at subinhibitory concentrations, and irradiated for 10, 20 and 30 minutes with a 400 nm-peaked light source. The phototoxicity tests on AGS cells were evaluated by MTT assay. Results: The photodynamic therapy and doxycycline combination showed an antibacterial synergistic effect with no significant toxicities. Conclusion: The synergistic treatment could be considered as an interesting therapeutic option.

Prise en charge thérapeutique des kératoses actiniques: Treatment of actinic keratoses.

Dermatologists have many therapeutic options for the management of actinic keratoses (AK), in order to treat individual lesions or wider areas. Field cancerization is an area of sun-damaged skin, where visible and subclinical lesions co-exist, and is prone to the development of further AK lesions and sun-related skin cancers (SC). Treatments available are instrumental or medical. Resistance to treatment or atypical symptoms must lead to a biopsy for histological exam. Cryotherapy is the most frequently used method to destroy small or isolated AK, whereas photodynamic therapy (PDT), 5-fluoro-uracil (5-FU), imiquimod, ingenol mebutate and diclofenac are required for large, multiple lesions, and for the treatment of field cancerization. Side-effects of these therapies are essentially local, including pain, irritation, erythema, edema and scars. There is no randomized comparative study reviewing all these treatments, therefore physicians must also consider clinical characteristics, patient's compliance, side-effects and cost when treating AK. Medicoeconomic data of these treatments have been analyzed in several countries, and annual costs are estimated between 250 € and 2 000 €, with an uncertain cost-effective relation. Finally, beyond treatment of AK lesions, patients with AK are at high risk of developing SC, and must therefore have regular full-body examination, in order to be detected and treated precociously. © 2019 Elsevier Masson SAS. All rights reserved. Cet article fait partie du numéro supplément Kératoses actiniques : comprendre et traiter réalisé avec le soutien institutionnel de Galderma International.

Combined Cancer Chemo-Photodynamic and Photothermal Therapy Based on ICG/PDA/TPZ-Loaded Nanoparticles.

Although photodynamic therapy (PDT) has been an attractive strategy for several cancer treatments in the clinical setting, PDT efficacy is attenuated by consumption of oxygen. To address this photodynamic issue, we adopted a phototherapy-chemotherapy combination strategy based on targeted delivery of the near-infrared photosensitizer indocyanine green (ICG), photothermal conversion agent polydopamine (PDA), and tirapazamine (TPZ), a hypoxia-activated prodrug. Under laser irradiation, ICG consumption of oxygen and aggravated hypoxia in tumor sites can activate TPZ to damage DNA. In parallel, ICG produces reactive oxygen species which work in synergy with PDA to enhance phototherapeutic efficiency. Herein, hybrid CaCO3/TPGS nanoparticles delivering ICG, PDA, and TPZ (ICG-PDA-TPZ NPs) were designed for effective and safe cancer therapy. ICG-PDA-TPZ NPs showed significantly improved cellular uptake and accumulation in tumors. Furthermore, we demonstrated that ICG-PDA-TPZ NPs showed intensive photodynamic and photothermal effects in vitro and in vivo, which synergized with TPZ in subcutaneous U87 malignant glioma growth and orthotopic B16F10 tumor inhibition, with negligible side effects. Thus, ICG-PDA-TPZ NPs could be an effective strategy for improvement of PDT.

Comparison of the efficacy of low-level laser therapy and photodynamic therapy on oral mucositis in rats.

Cancer treatment with chemotherapy or radiotherapy is associated with some side effects including in the oral cavity. One of the more significant oral complications is oral mucositis (OM) which induces severe pain and limits fundamental life behaviors such as eating, drinking, and talking. Although advancements in cancer treatment improved the survival rate, severe OM and opportunistic infection affect treatment adversely. Therefore, the control of OM is important for oral health quality of life and prognosis. Low-level laser therapy (LLLT) and photodynamic therapy (PT) are noninvasive methods that reduce inflammation and pain during wound healing. The aim of this study is to evaluate immunohistochemical and histological examination of the OM region of the PT comparing LLLT. In this study, 24 Sprague-Dawley rats were divided into three groups as control, LLLT, and PT groups. All groups received 5-fluorouracil intraperitoneally and a linear trauma to the mouth pouch with a needle. After the formation of OM in the mouth, the control group had no treatment; the LLLT group was administered LLLT, and the PT group had LLLT after indocyanine green application. Then all groups were sacrificed, and histological analyses and protein level detection of basic fibroblast growth factor (bFGF), transforming growth factor (TGF-ß), and platelet-derived growth factor (PDGF-BB) were evaluated in all groups. PT was determined to be more statistically significantly than LLLT with bFGF and PDGF-BB. However, regarding TGF-ß, no statistically significant difference was observed between the groups. Within the limitations of this study, indocyanine green may accelerate the LLLT effect. However, further studies on this subject are required.

Topical treatment with oleocanthal extract in reducing inflammatory reactions after photodynamic therapy: a prospective quasi-experimental pilot study.

OBJECTIVE: Photodynamic therapy (PDT) is an effective treatment against skin field cancerization. Its main side effect is local inflammation in the treated area. The phenolic compound oleocanthal (decarboxy methyl ligstroside aglycone), which is present in extra virgin olive oil (EVOO), has anti-inflammatory properties. The purpose of this study was to evaluate the topical efficacy of an oily fluid enriched with oleocanthal (OC) extract, in comparison with a conventional oily fluid, in reducing the degree of inflammatory reaction after conventional PDT. METHODS: Quasi-experimental pilot study, before-after with a control group, performed with a cohort of consecutive patients diagnosed with actinic keratosis/field cancerization (AK/FC) in the forehead and/or scalp, treated by PDT. The study was carried out from April 2016 to November 2017 at a speciality hospital in southern Spain. A group of 24 consecutive patients received the topical application, three times daily for one week, of an emollient oily fluid in the area treated with PDT. Subsequently, another group, of 23 consecutive patients, received the same treatment pattern with an oily fluid enriched with OC extract. The post-PDT inflammatory reaction was measured by an independent member of the hospital's dermatology department, using the following visual scale of erythema (from 0 to 4).The assessment was conducted at 30 min and at 48 h post-PDT. RESULTS: In the assessment at 48 h after treatment, the inflammation had improved more among the patients treated with OC (median: 25%, 95%CI: -5.3 to 28.5) than in the non-OC group (median: 0%; 95%CI: -45.2 to -6.2). The difference was statistically significant (p<0.01), and the Cohen's d value was 0.89 (large effect). At three months after PDT, a complete response had been obtained by 60.9% of the patients treated with OC compared to 29.2% of the non-OC group, and the difference was close to statistical significance (p=0.059). CONCLUSIONS: The topical application of an oily fluid enriched with OC extract achieved a greater reduction in post-PDT cutaneous inflammation and a better treatment response, in comparison with the application of a conventional oily fluid.