Efficacy and safety of a 0.05 % nanoencapsulated imiquimod hydrogel for the treatment of actinic cheilitis: Drug release analysis and clinical study.

Actinic cheilitis (AC) is a lip disorder, with no standard treatment. Imiquimod (IMIQ) is an immunomodulator that treat precancerous lesions; however, its commercial form causes severe adverse effects. This study aimed to assess IMQ release from a chitosan hydrogel containing 0.05 % nanoencapsulated (NANO) imiquimod (IMIQ-0.05 %-NANO) and its efficacy in AC treatment. The hydrogels were prepared by incorporating chitosan into polymeric nanocapsules (NCimiq) loaded with IMQ, produced using the interfacial deposition of preformed polymer method. IMQ release was evaluated using automated Franz Cells. A triple-blind randomized controlled trial (49 subjects) compared the efficacy of: IMIQ-0.05 %-NANO, 5 % free imiquimod (IMIQ-5 %), 0.05 % free imiquimod (IMIQ-0.05 %), and placebo hydrogel. The IMIQ-NANO-0.05 % and IMIQ-5 % groups exhibited significantly higher rates of clinical improvement (p < 0.05); however, the IMIQ-5 % group experienced more adverse effects (92.3 % of subjects) compared to other groups (p < 0.05). In conclusion, in the studied sample, IMIQ-NANO-0.05 % was a safe and effective option to treat AC.

Chronic nonspecific cheilitis associated with tislelizumab treatment in a patient with a history of tongue squamous cell carcinoma: a case report.

BACKGROUND: Chronic nonspecific cheilitis is a complex condition characterized by persistent lip peeling and discomfort. This case report explores the clinical progression of a patient with history of tongue squamous cell carcinoma and subsequent Tislelizumab treatment, presenting with persistent lip peeling. CASE PRESENTATION: A patient with a history of tongue squamous cell carcinoma (T2N0M0), treated with chemotherapy, surgery, and Tislelizumab, presented with six months of persistent lip peeling. Clinical examination revealed distinct features of chronic nonspecific cheilitis with infectious angular cheilitis (Oral Candidiasis). A tailored treatment plan, emphasizing oral hygiene practices and local treatments with Sodium Bicarbonate, Tacrolimus ointment, and Chlortetracycline ointment. Follow-up visits demonstrated sustained improvement, highlighting the significance of individualized approaches. CONCLUSIONS: This case underscores the importance of recognizing and managing oral manifestations in patients with a history of cancer and immunotherapy. The patient's response to treatment suggests that a multifaceted approach, combining local therapy with lifestyle modifications, can be effective in managing chronic nonspecific cheilitis associated with immunotherapy. Routine follow-up appointments, guided by personalized medicine principles, contribute to sustained patient well-being.

CLINICAL EFFICACY OF PHOTODYNAMIC THERAPY IN MANAGEMENT OF ORAL POTENTIALLY MALIGNANT DISORDERS: A SYSTEMATIC REVIEW AND META-ANALYSIS.

OBJECTIVES: Despite phototherapy (in the form of photodynamic therapy (PDT)-mediated oxidative stress) being utilized in the management of oral potentially malignant disorders (OPMDs), the evidence of certainty remains unclear. Hence, this systematic review and meta-analysis (PROSPERO # CRD42021218748) is aimed to evaluate the clinical efficacy of PDT-induced oxidative stress in OPMDs METHODS: PubMed, Embase, Web of Science, Scopus, and Cochrane Library databases were searched without restriction of language or year of publication. In addition, gray literature was searched and a manual search was performed. Two independent reviewers screened all the studies, assessing data extraction, risk of bias and certainty of evidence. A narrative synthesis was carried out. For the meta-analysis, random effects were considered to determine the prevalence of a total and a partial remission (PR) of oral potentially malignant disorders (OPMDs). The certainty of evidence was explored using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Twenty-three studies were included in the qualitative and quantitative syntheses. A total of 880 patients were included (564 males; 218 females) with an age range between 24 and 89-years-old. The results showed the prevalence of the total and partial remissions respectively for the following OPMLs: actinic cheilitis (AC): 69.9% and 2.4%; oral leukoplakia (OL): 44% and 36.9%; oral verrucous hyperplasia (OVH): 98.5%; oral erythroleukoplakia (OEL): 92.1% and 7.9%. The prevalence of no remission of OL was 18.8%. CONCLUSIONS: PDT demonstrated significant results in clinical remission of OPMDs and most of the eligible studies have shown a total or a partial remission of the included lesions, but at a low or a very low certainty of evidence. Hence, further clinical studies with robust methodology are warranted to offer further validated data. Also, further evidence is required to understand further the mechanism of PDT-induced oxidative stress.

Multiple noninvasive auxiliary tests-assisted photodynamic therapy in actinic cheilitis: A case report.

Actinic cheilitis (AC) is recognized as the most common precursor lesion of squamous cell carcinoma (SCC) of the lip, with a higher risk of invasiveness and metastasis. Early accurate diagnosis and appropriate therapy are essential to prevent carcinogenesis and progression of AC. Topical 5-aminolevulinic acid-mediated photodynamic therapy (ALA-PDT), a non-surgical and minimally invasive modality, has been proposed as an effective treatment for oral potentially malignant diseases (OPMDs) and oral cancers. Herein, we report a 64-year-old female patient with AC on the lower lip who received 3 sessions of ALA-PDT with an interval of 1 week. Multiple noninvasive auxiliary tests including autofluorescence imaging, toluidine blue staining, and aneuploidy with DNA image cytometry (DNA-ICM) using brushing from screening through diagnosis, treatment, and follow-up. The patient successfully showed a complete response with no adverse effects and no evidence of recurrence at the 20-month follow-up. Noninvasive auxiliary tests assisted PDT is attractive and well-tolerated and may have synergistic effects against AC.

Lip mesotherapy with dexpanthenol in the treatment of isotretinoin-induced cheilitis.

INTRODUCTION: Cheilitis is the most common mucocutaneous side effect of isotretinoin (ISO). Dexpanthenol (DXP) increases fibroblast proliferation and re-epithelialization in wound healing. We aimed to investigate the effect of DXP-mesotherapy in ISO-induced cheilitis in this study. METHODS: This study was conducted on patients who had been using ISO (0.5-1 mg/kg/day) for at least 2 months. Twenty-five patients who administered DXP-mesotherapy (mesotherapy group) and 33 patients without the procedure (control group, only ointment) participated in this study. All patients were prescribed only hamamelis virginiana distillate in ointment form as a lip balm. The efficacy of the treatment was interpreted by the change in lip balm use frequency, quality of life, and Isotretinoin Cheilitis Grading Scale (ICGS). RESULTS: There was a statistically significant decrease in all ICGS-subgroups scores in the mesotherapy group after 1 month compared with the baseline (p = <0.001), although in the controls, erythema, crust, and fissure scores significantly increased (p = 0.001, p = 0.002).While there was no difference between the groups in terms of ICGS total scores at baseline, there was a significant difference after 1 month in favor of the mesotherapy group (p < 0.001). In the mesotherapy group, lip balms were needed significantly less frequently and there was a significant improvement in quality of life compared with both the control group and at baseline after 1 month (both; p < 0.001). On the other hand, the control patients suffered more from cheilitis and dryness than at baseline (p < 0.001). CONCLUSION: Dexpanthenol-mesotherapy seems to be a safe, and so effective method in management of ISO-related cheilitis.

Efficacy of photodynamic therapy in actinic cheilitis: A systematic review.

BACKGROUND: Photodynamic therapy (PDT) has gradually developed into a promising modality for actinic cheilitis (AC), and many new PDT strategies are emerging. However, comprehensive reviews evaluating the efficacy of PDT strategies for AC are lacking. OBJECTIVE: To systematically review the safety and efficacy of PDT strategies for AC. METHODS: A systematic review was conducted using three databases to compare several types of PDT for AC in terms of clinical response (CR), histopathology response (HR), cosmetic result, and adverse events. RESULTS: A total of 19 studies were included, and 292 subjects were finally enrolled. The complete CR rate of ALA-patch PDT, traditional photodynamic therapy (T-PDT), and daylight photodynamic therapy (DL-PDT) was 80.00% (24/30), 65.14% (114/179), and 76.74% (33/43), respectively. The rate of painless patients was 87.10% (27/31) in DL-PDT, whereas the rate was only 31.25% (15/48) in T-PDT. The rates of moderate and severe local phototoxicity were 47.78% (43/90) in T-PDT, 0.00% (0/23) in DL-PDT, and 21.05% (4/19) in ALA-patch PDT. CONCLUSION: Published literature suggests that ALA-patch PDT seem to achieve high complete CR rate. Besides, DL-PDT might be a well-tolerated therapy compared with T-PDT and ALA-patch PDT. However, these assumptions are made based on very limited data. It is necessary to conduct a long-term larger sample randomized controlled trial to further evaluate the efficacy and adverse events of various PDT schemes for AC.

A single-center prospective pilot open-label study to assess the efficacy of topical application of an oxygen-enriched oil for the treatment of angular cheilitis.

PURPOSE: The aim of this pilot study was to clarify the acceptability and clinical efficacy of an oxygen-enriched oil-based gel for treatment of angular cheilitis. METHODS: A class IIb medical preparation, packaged in appropriate syringes, was tested. Patients were instructed how to use the gel for 10 days: finger rub application (3 times daily) on the dried lesion after meals, without eating, drinking, or speaking for at least 30 min thereafter. The Wilcoxon signed-rank test was used to assess whether there were any differences in the distributions of reported pain and lesion dimension. A microbiological examination was also performed with oral swabs; chi-squared test was used to compare the difference in the presence of microorganisms before and after treatment. RESULTS: Thirty patients were treated. A significant improvement in reported outcome and a significant reduction in the initially measured largest dimension of the lesion were observed after use of the clinical protocol. Additionally, a significant reduction in the pathogen count was found. CONCLUSION: Even if with limitations, data showed that this medical preparation facilitated prompt recovery from reported pain, without adverse reactions. Further work with a larger study population, and possibly a randomized control medication, will be needed.

Topical tacrolimus with different frequency for exfoliative cheilitis: a pilot study.

BACKGROUND: Tacrolimus is a new type immunosuppressant. The aim of this study was to evaluate the effectiveness of topical tacrolimus 0.1% ointment at 2 different frequencies in treating patients with exfoliative cheilitis. METHODS: A total of 40 patients with exfoliative cheilitis were randomly divided into the QD group receiving topical tacrolimus 0.1% ointment once a day or the QOD group receiving topical tacrolimus 0.1% ointment once-two-day. Patients were also applied wet dressing of saline twice a day. The effectiveness of treatment was defined as the percentage of improvement in signs or symptoms. RESULTS: 37 patients completed the 2-week treatment. And, a full set was analyzed. The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in the QD group, respectively. For the QOD group, the effectiveness of sign and symptom relief was 50% and 73.5%. There was no significant difference of effectiveness between application topical tacrolimus once a day and once 2 days. CONCLUSION: Our data suggested that application of topical tacrolimus 0.1% ointment once a day and once 2 days had similar clinical effectiveness for sign and symptom relief in patients with exfoliative cheilitis.

Use of topical anti-inflammatory and antineoplastic agents in the treatment of young-aged actinic cheilitis: A systematic review.

INTRODUCTION: Several treatments have been used to reduce inflammation and to reverse epithelial alterations in actinic cheilitis (AC). AIM: A systematic review was conducted to analyze the potential of topical treatments for remission and clinical improvement of AC as well as patient acceptability. METHODS: A systematic review of clinical trials was conducted following the PICO strategy to answer the following question: Are topical anti-inflammatory and antineoplastic agents effective in the treatment of actinic cheilitis? The quality of the studies was assessed by ROB-2, and the certainty of evidence was rated by GRADE guidelines. RESULTS: Eight clinical trials were selected, including four that investigated the use of anti-inflammatory drugs and four use of antineoplastic agents. The use of 3% diclofenac sodium was associated with partial remission of AC, while 5% imiquimod and ingenol mebutate promoted complete remission. Furthermore, 5% fluorouracil was the drug most associated with complications during treatment. Diclofenac sodium (3%) and fludroxycortide showed the best acceptance by the patients, especially in terms of symptom relief and comfort provided. CONCLUSION: The anti-inflammatory and antineoplastic agents analyzed largely provided good clinical outcomes, with evidence of remission of AC lesions, development of few local adverse reactions during treatment, and good patient adherence.

Abordagens terapêuticas não-cirúrgicas para a queilite actínica / Non-surgical therapeutics approaches for actinic cheilitis

A queilite actínica (QA) é uma desordem potencialmente maligna que se desenvolve principalmente no lábio inferior, decorrente da exposição crônica a luz solar. O objetivo desse estudo é elucidar, a partir de uma revisão da literatura, as abordagens não cirúrgicas mais atuais para o tratamento da QA. Foi realizada uma busca nas bases de dados PubMed, Scielo e Cochrane, sendo obtidos 280 artigos e após aplicação dos critérios de elegibilidade, foram utilizados no presente traba lho 16 estudos. Várias abordagens, como, diclofenaco sódico, mebutato de ingenol, imiquimode, 5-fluorouracil, fludroxicortida e terapia fotodinâmica, são apontadas e estudadas como forma de tratamento para a QA. Entretanto, faltam trabalhos para que se estabeleça um consenso sobre a terapêutica não-cirúrgica mais adequada... (AU)

Actinic cheilitis (AC) is a potentially malignant disorder that develops mainly on the lower lip, result ing from a chronic exposure to sunlight. The objective of this study is to elucidate, from a literature review, the most current non-surgical approaches for the treatment of AC. A search was performed in the PubMed, Scielo and Cochrane databases, obtaining 280 papers and after applying the eligibility cri teria, 16 studies were used in the present study. Various approaches, such as diclofenac sodium, ingenol mebutate, imiquimod, 5-fluorouracil, fludroxycortide and photodynamic therapy are pointed out and studied as a form of treatment for AC. However, there is a lack of work to establish a consensus on the most appropriate non-surgical therapy... (AU)

Combination of Laser Therapy and Photodynamic Therapy with 5-Aminolevulinic Acid Patch for the Treatment of Actinic Cheilitis.

Background: Actinic cheilitis (AC) is a premalignant lesion of the lips that can evolve into squamous cell carcinoma. Among nonsurgical treatments, photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) patch might represent a new noninvasive therapeutic approach for AC. Objective: We sought to investigate the potential role of fractional CO2 laser pretreatment in boosting ALA penetration and distribution into AC treated with PDT. Methods: We report a case of a woman with AC on the lower lip, treated with ablative fractional CO2 laser to boost drug delivery of 5-ALA patch before PDT treatment. Reflectance confocal microscopy was performed to assess diagnosis and treatment response. Results: We detected a good clinical and cosmetic outcome after two applications of combined treatment. Erythema, crust, and edema were reported as side effects. Conclusions: This case report shows that ablative fractional CO2 laser-assisted PDT might be an effective therapeutic alternative for patients with AC who refuse or are contraindicated for surgical procedures.

COMPLEX THERAPY OF ATOPIC CHEILITIS.

OBJECTIVE: The aim: Was to evaluate clinical data after the use of pimecrolimus (1% cream "Elidel") in patients with mild and moderate severity of atopic cheilitis, according to modern therapeutic requirements. There was an algorithm of treatment the patients with cheilitis proposed it based on the data from literary sources and personal clinical experience. PATIENTS AND METHODS: Materials and methods: 22 patients with atopic cheilitis aged from 19 to 40 agreed on a clinical examination in accordance with the protocol of the study. Patients were prescribed "Elidel" in the form of 1% cream for lubrication of the affected areas of the skin and lips, and antihistamine "Erius", for the normalization of the general condition used sedatives and vitamins after consultation of specialists in the general profile. RESULTS: Results: Patients of both groups during the re-examination after 3, 7, 10 days recorded a positive dynamics of the red border of the lips and skin: a significant reduction in the inflammatory process, normalization of indicators of general blood analysis, improvement in the overall quality of life of patients. CONCLUSION: Conclusions: The results of treatment allow to consider 1% cream "Elidel" (pimecrolimus) as a preparation of choice in the complex treatment of patients with atopic cheilitis of mild and moderate severity.

Effectiveness Of Oral Omega 3 In Reducing Mucocutaneous Side Effects Of Oral Isotretinoin In Patients With Acne Vulgaris.

BACKGROUND: Acne vulgaris has been a common clinical condition. Due to. high prevalence and unclear etio-pathogenesis of acne vulgaris, large number of treatment options have been available across the globe. Limited work has been done to explore the options which may manage or prevent these adverse effects and improve the adherence to the prescribed medications. We therefore conducted this trial to look for effectiveness of oral omega 3 in reducing mucocutaneous side effects of oral isotretinoin in patients with acne vulgaris. OBJECTIVE: To look for effectiveness of oral omega 3 in reducing mucocutaneous side effects of oral isotretinoin in patients with acne vulgaris. It was a randomized control trial conducted at Department of Dermatology Pak Emirates Military Hospital Rawalpindi. Ten months, June 2019 to May 2020. METHODS: A total of 60 patients of acne vulgaris put on oral isotretinoin by consultant dermatologist were included in the study. Patients were randomized into groups by lottery method. Group A received the placebo along with oral isotretinoin while Group B received oral omega 3 in standard dose in addition to oral isotretinoin. Comparison was made in both the groups regarding common mucocutaneous side effects. RESULTS: Out of 60patients with acne vulgaris and put on isotretinoin included in the study, 26 (43.3%) received placebo in addition to isotretinoin while 34 (56.7%) received omega 3 in addition to isotretinoin. Forty (66.7%) patients were female while 20 (33.3%) were male. Cheilitis 35 (58.3%) was the commonest side effect followed by lip dryness 33 (55%). Application of chi-square test revealed that cheilitis, lip dryness and xerosis were significantly found in more patients who received placebo as compared to those who received omega 3 along with isotretinoin. CONCLUSION: Mucocutaneous side effects were a very common finding among patients of acne vulgaris managed with isotretinoin. Cheilitis was the most reported mucocutaneous side effects among the target population. This RCT demonstrated that omega 3 was superior to placebo in order to prevent or manage cheilitis, xerosis or dry lips.