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Background: Actinic keratosis (AK) is one of the most common dermatologic diagnoses. While there are several treatment options, many topical therapies have poor adherence due to duration of treatment and local skin reactions (LSRs). Objective: To review the available literature on the most commonly used patient-administered field-directed therapies for AK and create consensus statements on the role of medication adherence in improving AK outcomes. Methods: A literature search of PubMed was completed for English-language original research articles reporting efficacy, safety, and tolerability data for 5-FU, diclofenac gel, imiquimod cream, and tirbanibulin. Once the articles were selected, they were distributed to a panel consisting of seven dermatologists with extensive expertise in managing AKs. Each panelist reviewed the articles and assigned them a level of evidence based on Strength of Recommendation Taxonomy (SORT) criteria. The panelists then met to review and discuss the studies and created consensus statements on the management of AKs and the importance of medication compliance. A modified Delphi process was used to approve the adoption of each statement. Results: The literature search produced 1,326 articles that met search criteria. After screening these articles for relevance and applying the inclusion criteria, 17 articles were chosen to be reviewed by the panel and assigned a level of evidence based on SORT criteria. The panel then created six consensus statements that received a unanimous vote for adoption. Conclusion: While there are several options for the treatment of AK, there is little consensus on a standard of care. Clearance rates for the most common topical field therapies vary significantly but are also difficult to directly compare due to differences in methodology for measuring and assessing outcomes. Overall, it is clear that an efficacious, tolerable, and convenient treatment for AKs is critical to optimal adherence and management and, given the results of recent studies, tirbanibulin may be the best topical option for meeting these criteria.

Background: Patients' experiences regarding topical actinic keratosis (AK) treatments may optimize clinical outcomes. PROAK study aimed to evaluate patient- and clinician-reported outcomes among adult patients with AK on face or scalp who were prescribed tirbanibulin in real-world clinical practice in the United States. Methods: Key primary endpoint was quality of life (QoL) assessed by Skindex-16. Additional endpoints were tirbanibulin treatment effectiveness and satisfaction (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire). Results: 290 patients were included in this analysis. At week 8, Skindex-16 scores improved in all domains (mean change from baseline [standard deviation, SD]: -14.3 [27.8] in symptoms, -24.9 [33.0] in emotions, and -9.8 [23.7] in functioning domain). Clinicians and patients reported high global satisfaction with tirbanibulin (mean [SD] scores of 78.8 [20.1] and of 74.5 [23.5]). Overall skin appearance improved from baseline to week 8 (91.0% clinicians; 84.1% patients). In comparison with previous treatments, tirbanibulin had shorter skin reactions duration (89.2% clinicians; 73.9% patients); milder skin reaction severity (91.0% clinicians; 76.6% patients); better daily activities impact (87.4% clinicians; 64.0% patients); and was easier to use (88.3% clinicians; 71.2% patients). Investigator’s Global Assessment (IGA) success (0-1) was achieved by 73.8% of the patients. Skin photodamage severity reduction from baseline to week 8 was significant (77.4% vs. 39.6%; p

Actinic keratosis (AK) is a common pre-neoplastic skin lesion constituted by uncontrolled proliferation of atypical keratinocytes that may evolve to squamous cell carcinoma. With global prevalence increasing, AK is expected to be the most common carcinoma of the skin. Tirbanibulin is a reversible tubulin polymerization inhibitor with potent anti-proliferative and anti-tumoral effects. In-vivo and in-vitro studies have shown that tirbanibulin significantly inhibits cell proliferation, tumor growth and downregulates Src signaling with no overt toxicity. Early phase and Phase III trials have shown high lesion clearance, compliance, and few side effects of once daily tirbanibulin treatment. This review discusses tirbanibulin anti-cancer activity, focusing on tubulin polymerization and Src signaling inhibitory effects, highlighting relevant literature and novel preclinical results from the ATNXUS-KX01-001 study. Furthermore, we address the relevant findings obtained in recent clinical trials to evaluate the safety, efficacy, pharmacokinetics, clearance efficacy, and side effects of the 1% tirbanibulin ointment applied once daily. In summary, we highlight preclinical and clinical evidence on the use of tirbanibulin as an effective and safe treatment option for AK.

OBJECTIVE: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. METHODS: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability. RESULTS: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12–17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions (P

Objectives: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment in alleviating AK disease burden in patients with AKs is not adequately understood. Objective of the analysis is to evaluate changes in patient-reported AK symptoms, emotions, and functioning, among patients with AKs treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, week-8 (timeframe for main endpoints) and week-24. Skindex-16, completed at baseline and week-8, is a 16-item survey with 3 domains: symptoms (items 1-4), emotions (items 5-11) and functioning (items 12-16), with each item scored on a seven-point adjectival response scale, with a potential score of 0 (never bothered) to 6 (always bothered). Changes from baseline in proportion of patients reporting a score of 0 or 1 (never or least bothered; i.e., least disease burden) was analyzed for all Skindex-16 items at week-8. Results: A total of 290 patients with AKs completed the study assessments at week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Within symptoms domain of Skindex-16 related to itching, burning/stinging, hurting, and irritation, proportion of patients reporting “never or least bothered” increased significantly for each item at week-8 (p

Introduction: The objective of this analysis was to compare patient and clinician satisfaction with tirbanibulin treatment’s ability to improve ‘how skin looks’ and ‘skin texture’ in the treated area, among patients with Actinic Keratosis (AK) treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with once-daily tirbanibulin treatment (5-day course) in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Patient’s self-reported satisfaction and clinician satisfaction with tirbanibulin treatment’s ability to improve ‘how skin looks’ and ‘skin texture’ in the treated area at individual patient-level were assessed among study patients at Week-8 on a seven-point adjectival response scale of 1 (extremely dissatisfied) – 7 (extremely satisfied). Results: A total of 290 patients with AKs completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture at baseline was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. All patients (100%) completed their 5-day once-daily treatment course. At Week-8, 75.86% & 78.97% of the patients and clinicians respectively reported extremely/very/satisfied with tirbanibulin’s ability to improve ‘how skin looks’, while 14.14% & 14.14% respectively reported somewhat satisfied, and 10.00% & 6.55% respectively reported extremely/very/dissatisfied. At Week-8, 74.83% & 80.69% of patients and clinicians respectively reported extremely/very/satisfied with tirbanibulin’s ability to improve their ‘skin texture’, while 15.52% & 12.41% respectively reported somewhat satisfied, and 9.65% & 6.55% respectively reported extremely/very/dissatisfied. Conclusion: A majority of patients with AKs and their clinicians reported satisfaction with the ability of 5-day treatment course of tirbanibulin to improve ‘how skin looks’ or ‘skin texture’ in the tirbanibulin-treated area, at Week-8.

The tubulin polymerization and Src kinase signaling inhibitor tirbanibulin is being investigated as a topical treatment for actinic keratosis, a precursor of squamous-cell carcinoma.In two identically designed double-blind trials, we randomly assigned, in a 1:1 ratio, adults with actinic keratoses on the face or scalp to receive either topical tirbanibulin or vehicle (placebo) ointment. The ointment was applied by the patients to a 25-cmA total of 702 patients were enrolled in the two trials (351 patients per trial). Complete clearance in trial 1 occurred in 44% of the patients (77 of 175) in the tirbanibulin group and in 5% of those (8 of 176) in the vehicle group (difference, 40 percentage points; 95% confidence interval [CI], 32 to 47; P0.001); in trial 2, the percentages were 54% (97 of 178 patients) and 13% (22 of 173), respectively (difference, 42 percentage points; 95% CI, 33 to 51; P0.001). The percentages of patients with partial clearance were significantly higher in the tirbanibulin groups than in the vehicle groups. At 1 year, the estimated percentage of patients with recurrent lesions was 47% among patients who had had a complete response to tirbanibulin. The most common local reactions to tirbanibulin were erythema in 91% of the patients and flaking or scaling in 82%. Adverse events with tirbanibulin were application-site pain in 10% of the patients and pruritus in 9%, all of which resolved.In two identically designed trials, tirbanibulin 1% ointment applied once daily for 5 days was superior to vehicle for the treatment of actinic keratosis at 2 months but was associated with transient local reactions and recurrence of lesions at 1 year. Trials comparing tirbanibulin with conventional treatments and that have longer follow-up are needed to determine the effects of tirbanibulin therapy on actinic keratosis. (Funded by Athenex; ClinicalTrials.gov numbers, NCT03285477 and NCT03285490.).

Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment on patients with AKs is not adequately understood. The primary objective of the study was to evaluate patient-reported outcomes in terms of AK symptoms, and impact of AKs on emotions and functioning, among AK patients treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AK of the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Skindex-16, completed at baseline and Week-8, is a 16-item survey with 3 domains: symptoms (4 items), emotions (7 items) and functioning (5 items), with each domain score computed on a scale of 0 to 100 with higher score indicating severe impairment due to AKs. Changes from baseline in Skindex-16 scores were analyzed. Results: A total of 290 AK patients completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Baseline Skindex-16 domain scores were: symptoms: 22.30, emotions: 38.17, functioning: 14.41. At Week-8, a statistically significant (p

Introduction: Actinic Keratosis (AK) are epidermal lesions with potential to progress to squamous cell carcinomas if left untreated. AKs have also been shown to negatively affect emotional functioning and skin-related quality of life of patients. The primary objective of the analysis was to evaluate IGA success at Week-8, and clinician-reported likelihood to consider tirbanibulin again for future treatments, among patients with AKs administered tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Clinicians assessed AK responses using an IGA on a five-point adjectival response scale of 0 (completely cleared), 1 (partially cleared), 2 (moderately cleared), 3 (minimally cleared) and 4 (not cleared). IGA success was defined as achieving an IGA score of 0 or 1 at Week-8. Clinicians also reported their likelihood to reuse tirbanibulin treatment for their patients, as a surrogate measure of satisfaction with the treatment. Results: A total of 290 AK patients completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). At Week-8, proportion of patients with completely/partially cleared AK (Approximately 75-100% clearance of AK lesions in the treated area, IGA 1/0) was 73.79%; moderately cleared (IGA 2) was 17.24%, and minimally cleared/not cleared (IGA 3/4) was 8.97%. Correspondingly, IGA success in this cohort of patients treated with tirbanibulin was 73.79%. Proportion of patients for whom clinicians noted that they would ‘somewhat or very likely’ consider tirbanibulin treatment again, if need arises, was 85.17%, with 7.59% reporting a neutral response, and 7.24% reporting ‘somewhat or very unlikely’ to consider treatment with tirbanibulin again. Conclusion: Overwhelming majority of patients with AK using tirbanibulin experienced IGA success at Week-8, and an overwhelming majority of clinicians reported their desire to consider tirbanibulin again to treat AK lesions for their patients.

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.

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Objective: Hyaluronic acid sodium salt gel 0.2% is a topical device effective in reducing skin inflammation. Facial seborrheic dermatitis, characterized by erythema and or flaking/scaling in areas of high sebaceous activity, affects up to five percent of the United States population. Despite ongoing study, the cause of the condition is yet unknown, but has been associated with yeast colonization and resultant immune derived inflammation. First-line management typically is with keratolytics, topical steroids, and topical antifungals as well as the targeted immunosuppressant agents pimecrolimus and tacrolimus. The objective of this study was to evaluate the efficacy and safety of a novel topical antiinflammatory containing low molecular weight hyaluronic acid. Design and setting: Prospective, observational, non-blinded safety and efficacy study in an outpatient setting. Participants: Individuals 18 to 75 years of age with facial seborrheic dermatitis. Measurements: Outcome measures included scale, erythema, pruritus, and the provider global assessment, all measured on a five-point scale. Subjects were assessed at baseline, Week 2, Week 4, and Week 8. Results: Final data with 13 of 17 subjects are presented. Hyaluronic acid sodium salt gel 0.2% was shown through visual grading assessments to improve the provider global assessment by 65.48 percent from baseline to Week 4. Reductions in scale, erythema, and pruritus were 76.9, 64.3, and 50 percent, respectively, at Week 4. At Week 8, the provider global assessment was improved from baseline in 92.3 percent of subjects. Conclusion: Treatment with topical low molecular weight hyaluronic acid resulted in improvement in the measured endpoints. Final data reveal continued improvement from that seen in the interim data shown previously. Topical low molecular weight hyaluronic acid is another option that may be considered for the treatment of facial seborrheic dermatitis in the adult population. Compliance and tolerance were excellent.

Cutaneous mastocytosis appears to occur sporadically; however, familial inheritance has been reported in 50 families since the mid-1880s. We report four cases of telangiectasia macularis eruptiva perstans (TMEP) occurring in three generations of a family. Whereas most patients with TMEP manifest in adulthood, all of the members of this family developed initial lesions during childhood. This is the third documented instance of familial mastocytosis affecting members of three generations, and the first report of familial TMEP. Although the inheritance pattern is unknown, the presentation of disease in this family further supports the hypothesis of an autosomal dominant mode of transmission with incomplete penetrance.