Focused update: Guidelines of care for the management of actinic keratosis.

BACKGROUND: Actinic keratoses (AKs) are rough scaly patches that arise on chronically UV-exposed skin and can progress to keratinocyte carcinoma. OBJECTIVE: In 2021, the American Academy of Dermatology published guidelines to assist in clinical decision-making for the management of AK. The purpose of this focused guideline update is to incorporate recently available evidence on the use of topical tirbanibulin to treat AK. METHODS: A multidisciplinary work group conducted a systematic review to evaluate data on the use of tirbanibulin for AK and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of the evidence and formulating and grading a clinical recommendation. The graded recommendation was voted on to achieve consensus. RESULTS: Two trials were identified, and analysis of the evidence resulted in 1 recommendation. LIMITATIONS: This analysis is based on the best available evidence at the time it was conducted. Long-term efficacy and safety data are not currently available. CONCLUSIONS: A strong recommendation for the use of topical tirbanibulin to join the currently recommended list of topical therapies for AK was made on the basis of the available evidence.

Evidence-Based Consensus Recommendations for the Evolving Treatment of Patients with High-Risk and Advanced Cutaneous Squamous Cell Carcinoma.

Cutaneous squamous cell carcinoma is the second most common skin cancer in the United States. Currently, there is no standardized management approach for patients with cutaneous squamous cell carcinoma who develop metastatic or locally advanced disease and are not candidates for curative surgery or curative radiation. To address this issue, the Expert Cutaneous Squamous Cell Carcinoma Leadership program convened an expert steering committee to develop evidence-based consensus recommendations on the basis of a large, structured literature review. Consensus was achieved through modified Delphi methodology. The steering committee included five dermatologists, three medical oncologists, two head and neck surgeons, one radiation oncologist, and a patient advocacy group representative. The steering committee aligned on the following clinical topics: diagnosis and identification of patients considered not candidates for surgery; staging systems and risk stratification in cutaneous squamous cell carcinoma; the role of radiation therapy, surgery, and systemic therapy in the management of advanced disease, with a focus on immunotherapy; referral patterns; survivorship care; and inclusion of the patient's perspective. Consensus was achieved on 34 recommendations addressing 12 key clinical questions. The Expert Cutaneous Squamous Cell Carcinoma Leadership steering committee's evidence-based consensus recommendations may provide healthcare professionals with practically oriented guidance to help optimize outcomes for patients with advanced cutaneous squamous cell carcinoma.

Guidelines of care for the management of actinic keratosis: Executive summary.

BACKGROUND: Actinic keratoses (AK) are rough scaly patches that arise on chronically ultraviolet-exposed skin and can progress to keratinocyte carcinoma. Treatment options for AK include topical medications, photodynamic therapy, cryosurgery, and laser ablation. OBJECTIVE: This executive summary provides a synopsis of the 18 evidence-based recommendations for the treatment of AK detailed in the Guidelines of Care for the Management of Actinic Keratosis. METHODS: A multidisciplinary workgroup conducted a systematic review to address 5 clinical questions on the management of AKs and applied the Grading of Recommendations Assessment, Development and Evaluation approach for assessing the certainty of the evidence and formulating and grading clinical recommendations. Graded recommendations were voted on to achieve consensus. RESULTS: Analysis of the evidence resulted in 18 recommendations, suggesting there are several effective treatments available for AK. LIMITATIONS: The analysis informing the recommendations was based on the best available evidence at the time it was conducted. The results of future studies may necessitate a revision of current recommendations. CONCLUSIONS: Strong recommendations are presented for using ultraviolet protection, topical imiquimod, topical 5-fluorouracil, and cryosurgery. Conditional recommendations are presented for the use of photodynamic therapy and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.

A Series of Tattoo-associated Mycobacterium Fortuitum Infections.

Mycobacterium fortuitum is a rapidly growing mycobacterium known to spread through many sources, including tap water. This organism can have variable presentation between patients which can lead to a delay in diagnosis. Here, we report a series of eight cases of tattoo-associated M. fortuitum infections that presented between December 2010 and January 2011, which were later linked to a single tattoo provider using gray tattoo ink made by diluting black ink with nonsterile tap water. In this case series, we emphasize the lack of pathognomonic features of these infections, the variability in culture and biopsy results, the importance of obtaining a culture in addition to a biopsy, and the importance of identifying the source of infection when determining management.

Guidelines of care for the management of actinic keratosis.

BACKGROUND: Actinic keratoses (AK) are rough scaly patches that arise on chronically ultraviolet-exposed skin and can progress to keratinocyte carcinoma. OBJECTIVE: This analysis examined the literature related to the management of AK to provide evidence-based recommendations for treatment. Grading, histologic classification, natural history, risk of progression, and dermatologic surveillance of AKs are also discussed. METHODS: A multidisciplinary Work Group conducted a systematic review to address 5 clinical questions on the management of AKs and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of the evidence and formulating and grading clinical recommendations. Graded recommendations were voted on to achieve consensus. RESULTS: Analysis of the evidence resulted in 18 recommendations. LIMITATIONS: This analysis is based on the best available evidence at the time it was conducted. The pragmatic decision to limit the literature review to English language randomized trials may have excluded data published in other languages or limited identification of relevant long-term follow-up data. CONCLUSIONS: Strong recommendations are made for using ultraviolet protection, topical imiquimod, topical 5-fluorouracil, and cryosurgery. Conditional recommendations are made for the use of photodynamic therapy and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.

Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis.

OBJECTIVE: To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis. METHODS: A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16. RESULTS: 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated. CONCLUSIONS: In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.

Postmarket Experience of Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: This report synthesizes 12 years of postmarket surveillance data (PMSD) for polymethylmethacrylate (PMMA)-collagen gel dermal filler. OBJECTIVE: To present PMMA-collagen gel PMSD findings on real-world safety. METHODS: Postmarket surveillance data were collected from January 2007 to December 2018 and evaluated to determine the overall adverse event (AE) complaint rate, the nature of reported AEs, and whether the complaint included on-label, off-label, both, or unknown areas. RESULTS: In the 12 years examined, 754,229 PMMA-collagen gel syringes were distributed worldwide, and 839 product-related complaints (including those classified as unknown) resulted in an overall complaint rate of 0.11%. The 3 most frequent primary complaints in AE reports were lump/bump (309/839, 37%), nodule (152/839, 18%), and swelling (138/839, 16%). Histologically confirmed granuloma accounted for 17/839 complaints (2.0%; overall complaint rate of 0.002%), and histologically unconfirmed granuloma accounted for 66/839 complaints (8%; overall rate of 0.009%). There were 666 complaints representing AEs related to off-label injection in which the periocular area was most frequently represented. CONCLUSION: Although a limiting factor across all PMSD is voluntary reporting and resultant underrepresentation of AEs, the PMSD reported here are consistent with safety findings from US clinical studies in more than 1,500 patients with up to 5 years of follow-up.

Novel Tretinoin 0.05% Lotion for the Once-daily Treatment of Moderate-to-severe Acne Vulgaris in a Preadolescent and Adolescent Population.

Background: The efficacy of tretinoin is well documented in adolescent acne, with limited data available in preadolescents. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well tolerated in moderate-to-severe acne. Objective: We sought to evaluate the safety and efficacy of tretinoin 0.05% lotion in preadolescent (≤13 years) and adolescent (14-17 years) subjects with acne. Methods: This study involved the post-hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase III studies. Preadolescent (n=154) and adolescent (n=575) subjects were randomized (1:1) to tretinoin 0.05% lotion or vehicle used once daily for 12 weeks. Efficacy assessments included lesion count reductions, treatment success (at least a two-grade reduction in the Evaluator's Global Severity Score and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated. Results: At Week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% in preadolescents and 50.5% and 41.2% in adolescents, compared to 31.4%, 18.8%, 35.9%, and 23.8% for the vehicle, respectively (all p≤0.001). Treatment success was achieved by 23.7% (preadolescent) and 17.5% (adolescent) of subjects by Week 12, compared to 7.2% (p=0.009) and 8.8% (P=0.004) with the vehicle. The majority of AEs were mild and transient; the most frequent occurrences were application site pain and dryness in 5.6% and 2.8% of preadolescents and 3.2% and 3.6% of adolescents. Local cutaneous safety and tolerability assessments were generally mild-to-moderate, with slight transient increases in mean scores at Week 4. Conclusions: Tretinoin 0.05% lotion was significantly more effective than the vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent and adolescent acne. It was well tolerated, and all treatment-related AEs were mild or moderate.

Enhancing Outcomes in Seborrheic Keratosis: Using a Novel Treatment Solution

Seborrheic keratosis (SK) is an extremely common benign cutaneous lesion that often appears on individuals older than the age of 50. SK lesions can appear in numerous clinical variations, but typically, SKs present with a well-demarcated, "stuck-on" appearance having a waxy or keratotic surface. Even though SK lesions are usually benign, many individuals elect for SK treatment or removal due to cosmetic concerns. One study regarding SK appearance reported that 61% of women tried to conceal the appearance of the SKs by using certain hairstyles, make-up, and clothes. Conventional treatment for SK lesions ranges from cryosurgery to curettage. Although these removal methods are effective for SK treatment, each method contains a potential for side effects such as pigmentation changes, scarring, and discomfort before and after the procedure. Due to many of these concerns, patients prefer topical treatments for SKs, which has led to a new emerging topical containing hydrogen peroxide topical solution 40% (HP40; Eskata™). Here, we report the methods and results from an HP40 treatment for two individuals, each over 70 years old. Application of the topical solution was performed on each target SK, up to four times, with a 20-second application and 1 minute between applications. The two participants reported moderate success of HP40 in the removal of their SKs with minimal adverse effects. J Drugs Dermatol. 2019;18(7 Suppl):s178-182.

Treatment of Atrophic Facial Acne Scars With Microneedling Followed by Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied. OBJECTIVE: The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars. METHODS: We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group). RESULTS: At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.

Addressing Free Radical Oxidation in Acne Vulgaris.

OBJECTIVE: Comparatively little attention has been paid to the role of free radical oxidation in acne vulgaris. Here, using the traditional abnormalities cited for acne, the authors address the role of free radical oxidation throughout the pathogenesis by detailing the chemistry that may contribute to clinical changes. To probe the effects of free radical oxidation and test an antioxidant, they conducted a preliminary study of topically applied vitamin E. METHODS: Seventeen patients with mild-to-moderate acne vulgaris were evaluated over an eight-week period in two private dermatology practices in this open-label study. All patients enrolled were on the same baseline regimen of salicylic acid and benzoyl peroxide. This regimen was then supplemented with topical vitamin E in sunflower seed oil. RESULTS: At the end of the eight-week period, all patients demonstrated clinical improvement, as indicated by a reduction in the number of lesions and global mean difference. A statistically significant reduction was noted as early as Week 2. Enrolled patients also expressed a positive experience due to good tolerability and easy application. CONCLUSION: Although the exact pathogenesis of acne vulgaris remains unknown, the presence of excessive reactive oxygen species can be implicated in each of the major abnormalities involved. This presence, along with the positive results of the authors' preliminary study, demonstrates the need for more exploration on the use of topical antioxidants in limiting free radical oxidation in the acne model. This paper is designed to stimulate academic discussion regarding a new way of thinking about the disease state of acne.

Purpura and fillers: a review of pre-procedural, intra-procedural, and post-procedural considerations.

Injectable aesthetic fillers are associated with the common and expected side effect of purpura or bruising. There are pre-procedural, intra-procedural and post-procedural considerations that can potentially minimize bruising. Traditional and newer techniques are discussed in this review and the benefits and risks of each technique will be provided.

Efficacy and tolerability of low molecular weight hyaluronic acid sodium salt 0.2% cream in rosacea.

OBJECTIVE: Rosacea is a chronic cutaneous disorder characterized by flushing, erythema, telangiectasia, edema, papules, and pustules. The cause of this inflammatory disorder is unknown, but is thought to be multifaceted. Primary treatments for rosacea are typically oral antibiotics and topical therapies. Hyaluronic acid sodium salt cream 0.2% is a topical device containing low molecular weight hyaluronic acid (LMW-HA) that is effective in normalizing the cutaneous inflammatory response. The objective of this study was to evaluate the efficacy and safety of hyaluronic acid sodium salt cream 0.2%. DESIGN AND SETTING: Prospective, observational, non-blinded efficacy and tolerability study in an outpatient setting. PARTICIPANTS: Individuals 18 to 75 years of age with mild to moderate facial rosacea. MEASUREMENTS: Outcome measures included papules, pustules, erythema, edema, telangiectasia, burning or stinging, dryness and provider global assessment (PGA), which were all measured on a five-point scale. Subjects were assessed at baseline, week 2, week 4, and week 8. RESULTS: Final data for 14 of 15 subjects are presented. Through visual grading assessments, hyaluronic acid sodium salt cream 0.2% was shown to improve the provider global assessment by 47.5 percent from baseline to week 4. Reductions in papules, erythema, burning or stinging, and dryness were 47, 51.7, 65, and 78.8 percent, respectively at week 4. At week 8, the provider global assessment was improved from baseline in 78.5 percent of subjects. CONCLUSION: Improvement was noted in measured clinical parameters with use of topical low molecular weight hyaluronic acid. Topical low molecular weight hyaluronic acid is another option that may be considered for the treatment of rosacea in the adult population. Compliance and tolerance were excellent. Consideration should be given to use for individuals with rosacea characterized by an erythematous and/or papular component.

Successful Breast Conservation in a Patient with Epidermolysis Bullosa Simplex.

Before breast conservation can be offered to a woman with breast cancer one must understand both the indications and contraindications to such an approach. Factors that play a role in this decision include tumor-related factors and factors related to the expected cosmetic outcome following breast conservation. Here we present a case of a woman with epidermolysis bullosa simplex (EBS), a rare skin disorder that is characterized by blister formation following minor trauma, who underwent successful breast conservation.