Publications by authors named "Julie Harper"

Background: There are numerous over-the-counter products for treating acne, although many formulations have tolerability issues and lack the cosmetic elegance desired by adult patients.

Objective: The objective of this study was to evaluate the efficacy and tolerability of a non-prescription, active acne regimen in adult patients of all Fitzpatrick skin types.

Method: Thirty-five male and female subjects with Fitzpatrick skin types I-VI were enrolled in this single-site, monadic 8-week study.

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Article Synopsis
  • Topical clindamycin phosphate/adapalene/benzoyl peroxide (CAB) gel is approved for treating acne in patients 12 and older, and post hoc analyses examined its effectiveness in younger patients with acne.
  • Data from two studies showed that CAB significantly improved treatment success and reduced acne lesions in adolescents compared to a vehicle gel, with 51.5% of treated adolescents achieving success versus 24.9% with the vehicle.
  • The CAB gel was generally well tolerated, with most adverse events being mild to moderate, and it was effective for younger children as well, with significant lesion reductions observed in all treated children.
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  • Topical CAB gel, a combination of clindamycin phosphate, adapalene, and benzoyl peroxide, is the only approved treatment for moderate-to-severe acne using a triple formulation, showing superior results in clinical studies compared to individual components.
  • In two phase 3 studies, participants aged 9 and older were treated with CAB or a placebo, resulting in over 70% reduction in acne lesions for all CAB-treated cases by week 12, with most achieving clear skin or a notable reduction in severity.
  • Overall findings indicated CAB is effective and well-tolerated, emphasizing the need for patient education on adherence and managing expectations regarding side effects.
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  • Clindamycin phosphate/adapalene/benzoyl peroxide gel (CAB) is the only approved triple-combination treatment for acne, and a post hoc analysis evaluated its efficacy and safety based on sex.
  • In two phase 3 clinical studies, participants aged 9 and older with moderate-to-severe acne were treated with CAB or a placebo for 12 weeks, and outcomes were analyzed by sex regarding treatment success, lesion counts, quality of life, and side effects.
  • Results showed that CAB was significantly more effective than the vehicle for both sexes in reducing acne severity and improving quality of life, with no notable differences in safety or efficacy between male and female participants.
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Background: Dermatoporosis (DP) is a condition associated with thinning skin layers and resultant fragility. Much of the thinning is related to fibroblast dysfunction, production of destructive inflammatory cytokines, breakdown of the extracellular matrix (ECM), and weakening of the dermo-epidermal junction. A major contributor to this change in the ECM milieu, previously under-considered, is cellular senescence, particularly involving the papillary dermal fibroblasts.

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Article Synopsis
  • The study analyzes the effectiveness and safety of a new acne treatment gel (CAB) that combines clindamycin, adapalene, and benzoyl peroxide, focusing on both pediatric (<18 years) and adult populations.
  • In a phase 3 trial involving participants aged 9 and older, CAB was found to significantly improve acne symptoms more than the vehicle gel after 12 weeks of treatment, with success rates of 52.7% in pediatric and 45.9% in adult participants.
  • The results indicated that CAB led to greater reductions in both inflammatory and non-inflammatory acne lesions and improved quality of life while demonstrating acceptable safety and tolerability across all age groups.
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  • Oral isotretinoin is a key treatment for severe nodular acne, with newer formulations like lidose and micronized isotretinoin developed to improve effectiveness.
  • A group of expert dermatologists created five consensus statements on these novel formulations, focusing on their efficacy, tolerability, and side effects, all of which received strong agreement.
  • Micronized isotretinoin is noted for its increased bioavailability, potentially requiring lower doses and no need for cumulative dosing calculations, making it a flexible option in acne treatment.
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  • * In a 12-week double-blind study involving over 360 participants aged 9 and older, CAB led to a 50% success rate in achieving clear skin, significantly outperforming a placebo gel, with over 70% reduction in both inflammatory and non-inflammatory acne lesions.
  • * The treatment showed a good safety profile, with only mild to moderate side effects and a low discontinuation rate due to adverse events, indicating CAB could be a promising option for those suffering from moderate
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  • Inconsistent reporting of outcomes in rosacea clinical trials is hindering accurate data analysis and meta-analyses, highlighting the need for standardized outcome measures.
  • A core outcome set (COS) was developed through systematic literature reviews and a Delphi process, involving feedback from physicians and patients to identify essential outcomes in rosacea trials.
  • The final COS includes 8 key domains, such as skin symptoms and patient satisfaction, which aim to enhance the comparability and relevance of future rosacea research and interventions.
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Background: Multiple treatment options exist for the management of moderate-to-severe acne. However, the comparative effectiveness (efficacy/safety) of moderate-to-severe acne treatments has not been systematically examined.

Methods: A systematic literature review (SLR) was conducted to identify randomized controlled trials of ≥4 weeks of treatment (topical, oral, physical, or combinations) for moderate-to-severe facial acne in patients aged ≥9 years.

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Article Synopsis
  • - The study shows that a once-daily, three-in-one topical acne treatment (CAB gel) combining an antibiotic, antibacterial, and retinoid leads to faster and greater improvements in acne lesions compared to dual combinations or vehicle gel.
  • - In phase 2 and phase 3 trials, CAB gel users saw significant reductions in both inflammatory and noninflammatory acne lesions as early as week 4, with better results sustained over 12 weeks.
  • - By the end of the 12-week treatment, a higher percentage of participants using CAB gel achieved significant reductions in their acne compared to those using other combinations or placebo treatments.
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  • Rosacea is a common chronic skin condition in the USA that causes social and professional stigma, making effective management important for improving patients' quality of life.
  • Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a new FDA-approved topical treatment that enhances therapeutic response and reduces skin irritation, though it isn't yet in clinical guidelines.
  • A review of various FDA-approved treatments, including E-BPO 5%, highlights its rapid efficacy, good tolerability, and potential long-term benefits for managing rosacea-related symptoms.
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  • Patient-reported outcomes (PROs) are being recognized as important in assessing the impact of acne vulgaris (AV), particularly with the use of sarecycline in real-world settings, which lacks existing data.
  • A study involved 253 patients aged 9 and older with moderate or severe non-nodular AV, who were treated with sarecycline for 12 weeks, demonstrating significant improvements in symptoms and psychosocial impacts as measured by the Acne Symptom and Impact Scale.
  • Results showed a 58.9% success rate in reducing AV severity and 88.1% physician satisfaction, with some patients reporting side effects, highlighting the efficacy of oral antibiotic treatment in managing AV symptoms.
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Background: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients’ functioning and activities of daily living (ADL) are needed.

Methods: A 12-week, single-arm, prospective cohort study was conducted in patients ≥9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (>12 years) and caregivers (for patients 9-11 years).

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Acne Vulgaris (AV) is a prominent skin disease commonly affecting teenagers. It often persists into adulthood and is associated with adverse physical and psychosocial impacts. The pathophysiology of AV is conventionally correlated with 4 factors within and around the pilosebaceous unit: increased sebum production, follicular hyperkeratinization, Cutibacterium acnes proliferation, and localized immune responses.

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Rosacea is a common, chronic inflammatory disease characterized by both fluctuating and fixed heterogeneous signs such as facial erythema, papules/pustules, telangiectasia, acute vasodilation (flushing), and phymatous changes, and symptoms such as cutaneous stinging and burning. The shift to a phenotype-based approach to rosacea management has improved the consistency of recommendations across recent published guidelines. Consistent and thorough guidance for the classification, diagnosis, and management of the disease is difficult, as the mechanisms underlying the development of rosacea are still not completely understood nor universally accepted.

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  • The study assessed the effectiveness and safety of tazarotene 0.045% lotion in treating acne during different seasons, comparing warmer months to colder months.
  • Participants aged nine and older, with moderate-to-severe acne, used tazarotene or a placebo lotion in randomized trials, showing consistent results across seasons.
  • Results indicated that tazarotene significantly reduced both inflammatory and noninflammatory lesions regardless of the season, with minor side effects, suggesting it is a viable acne treatment year-round.
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Background: Acne, a commonly treated skin disease, requires patient-centered management due to its varying presentations, chronicity, and impact on health-related quality of life. Despite this, evidence-based clinical guidelines focus primarily on clinical severity of facial acne, omitting important patient- and disease-related factors, including ongoing management.

Objectives: To generate recommendations to support patient-centered acne management, which incorporate priority and prognostic factors beyond conventional clinical severity, traditionally defined by grading the appearance and extent of visible lesions.

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Benzoyl peroxide (BPO) has been used extensively in industry and health care for more than a century and has been approved for the treatment of acne for over 60 years. Recently, BPO received a second approved indication by the US Food and Drug Administration (FDA) for the treatment of rosacea. Topical BPO use has historically been limited by tolerability, photosensitivity, oxidation, and, uncommonly, contact allergy.

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Background: Vestibular side effects such as dizziness and vertigo can be a limitation for some antibiotics commonly used to treat acne, rosacea, and other dermatology indications.

Objective: Unlike minocycline, which is a second-generation tetracycline, sarecycline, a narrow-spectrum third-generation tetracycline-class agent approved to treat acne vulgaris, has demonstrated low rates of vestibular-related adverse events in clinical trials. In this work, we evaluate the brain-penetrative and lipophilic attributes of sarecycline in 2 non-clinical studies and discuss potential associations with vestibular adverse events.

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Introduction: Rosacea is a chronic condition involving inflammation leading to a diminished skin barrier function in sebaceous gland-rich facial skin. The current algorithm represents part II of a series investigating similar topics associated with preventing, treating, and maintaining rosacea, including ceramides-containing skincare.

Methods: The consensus process consisted of a modified Delphi technique.

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Background: Dysregulation of either the cutaneous microbiome (CM) or epidermal barrier function (EBF) is thought to play an increasingly important role in acne vulgaris (AV) and rosacea pathogenesis.

Objective: To review the literature regarding epidermal barrier dysfunction (EBD) and cutaneous dysbiosis in AV and rosacea and provide clinical pearls for dermatologists.

Methods: A Medline literature search was performed for relevant literature regarding EBD and dysbiosis and either AV or rosacea.

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Introduction: Half of the individuals with facial acne develop truncal acne, but the impact of combined facial and truncal acne (CA) on patients' quality of life is poorly researched.

Methods: A 60-min interview of 30 participants with CA was conducted that formed the basis for a cross-sectional survey of 694 adolescents and adults with CA.

Results: The main themes identified from the qualitative interviews among CA subjects included acceptability to self and others, social functioning and emotional wellbeing.

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Background: Most people with acne are at risk of developing acne scars, but the impact of these scars on patients' quality of life is poorly researched.

Objective: To assess the perspective of patients with acne scars and the impact of these scars on their emotional well-being and social functioning.

Methods: A 60-minute interview of 30 adults with acne scars informed and contextualized the development of a cross-sectional survey of 723 adults with atrophic acne scars.

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