BACKGROUND: Oral lichen planus (OLP) patients with erythematous or erosive gingival lesions frequently fail topical therapy. The aim of this study was to determine the efficacy of minocycline and doxycycline for inflamma...BACKGROUND: Oral lichen planus (OLP) patients with erythematous or erosive gingival lesions frequently fail topical therapy. The aim of this study was to determine the efficacy of minocycline and doxycycline for inflammatory and refractory gingival OLP. METHODS: In this retrospective analysis, the data of 254 patients with biopsy-confirmed OLP who displayed inflammatory gingival lesions and failed treatment with topical agents were analyzed. Patients treated between 2015 and 2023 with a 2-month course of either doxycycline 100 mg twice daily or minocycline 100 mg twice daily, concomitantly with topical agents, were included. RESULTS: After 2 months of treatment with doxycycline or minocycline, 60.6% patients improved with a marked reduction in erythema (95% CI 54.6%-66.6%). More specifically, in patients with mild gingival inflammation at baseline, 80.3% improved (95% CI 71.3%-89.2%) compared to 29.4% of patients with desquamative gingivitis at baseline (95% CI 16.9%-41.9%). Acute flare-ups after discontinuing therapy, which developed in approximately 25% of patients, responded to additional courses of antibiotics for 1to 2 months. Mild adverse effects were noted in 10 patients, which all resolved rapidly when the drug was discontinued. CONCLUSIONS: This study demonstrates that both doxycycline and minocycline are highly effective agents for inflammatory gingival OLP lesions that are difficult to palliate. As these patients often fail to respond to topical agents and require more aggressive systemic drugs that are immunosuppressive with significant adverse effects, second-generation tetracyclines should be considered first-line systemic agents for inflammatory gingival OLP lesions.
BACKGROUND: Racial disparities in clinical trial enrollment can limit the generalizability of therapeutic data, which is particularly damaging for conditions that disproportionately impact minority patients, such as myco...BACKGROUND: Racial disparities in clinical trial enrollment can limit the generalizability of therapeutic data, which is particularly damaging for conditions that disproportionately impact minority patients, such as mycosis fungoides and Sézary syndrome. OBJECTIVE: To characterize the racial demographics of mycosis fungoides/Sezary syndrome (MF/SS) clinical trials and explore potential barriers to enrollment for Black patients in the United States (US). METHODS: We searched the terms "mycosis fungoides," "Sezary syndrome," "CTCL," and "Cutaneous T-Cell Lymphoma" on ClinicalTrials.gov. Interventional trials that were completed with results posted and had at least one site within the US were included. We assessed racial demographics, trial enrollment proportions relative to 2023 US Census data, geographic access, exclusion criteria, and race-based reporting practices. RESULTS: A total of 1483 participants across 27 trials were characterized, 154 (10.4%) of whom identified as Black. Compared to population data from the 2023 US Census, Black patients were significantly underrepresented (P<0.001) in MF/SS trials overall, overrepresented in Phase 1 trials (P=0.013), and underrepresented in Phase 3 trials (P<0.001). Most trial sites (69%) were in areas with moderate (12.6-49.9%) to high (≥50%) Black populations. There were no significant differences in exclusion criteria between low- and high-Black-enrolling trials. Of 36 trial-related publications identified, only 14 (39%) reported participant race. CONCLUSIONS: The findings of this study reveal significant racial disparities in MF/SS clinical trial enrollment. Identifying these disparities and investigating barriers to enrollment ensures that MF/SS patients of all racial backgrounds are appropriately represented at each phase of the experimental process.  .
Acrodermatitis continua of Hallopeau (ACH) is a rare, localized variant of pustular psoriasis that primarily affects the distal digits and nail apparatus, often presenting with recurrent pustules, nail dystrophy, and sig...Acrodermatitis continua of Hallopeau (ACH) is a rare, localized variant of pustular psoriasis that primarily affects the distal digits and nail apparatus, often presenting with recurrent pustules, nail dystrophy, and significant functional impairment. Due to its rarity and chronic relapsing course, ACH is notoriously difficult to treat, and standardized treatment guidelines are lacking. We present the case of a 67-year-old male with ACH who failed multiple therapies, including corticosteroids, topical tapinarof, and oral deucravacitinib, before achieving rapid and sustained improvement with bimekizumab, a monoclonal antibody targeting interleukin-17A and IL-17F. Within one month of initiating bimekizumab, the patient experienced marked clinical improvement in both skin lesions and joint pain, with continued progress allowing him to return to work. This case highlights the potential utility of dual IL-17A/F inhibition in neutrophil-dominant pustular conditions such as ACH. As more case reports document favorable outcomes, bimekizumab may emerge as a valuable treatment option for patients with refractory ACH, offering targeted cytokine blockade in a condition with few effective therapies.  .
INTRODUCTION: Dominant dystrophic epidermolysis bullosa (DDEB) is a hereditary genetic disorder with a mutation of the type VII collagen gene (COL7A1), leading to a destabilized dermal-epidermal junction. Current treatme...INTRODUCTION: Dominant dystrophic epidermolysis bullosa (DDEB) is a hereditary genetic disorder with a mutation of the type VII collagen gene (COL7A1), leading to a destabilized dermal-epidermal junction. Current treatments for DDEB are supportive, and new gene therapies are being developed to target DDEB. However, gene therapy can be expensive. CASE REPORT: A 59-year-old woman presented with eroded blisters on her right lower extremity. Genetic testing identified a pathogenic COL7A1 mutation, confirming the diagnosis of DDEB. She was treated with 6 weeks of gentian violet and trichloroacetic acid peel, resulting in significant improvement of her lesions. DISCUSSION: DDEB is characterized by dysregulated inflammation of chronic wounds and aberrant fibroblast activity. Gentian violet and trichloroacetic acid may address inflammation while reducing fibroblast activity and preventing infection. The treatment worked well for the patient, and there was minimal pain with the application of these topical therapies.  .
BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable biostimulatory filler used for restoring facial fat volume loss. OBJECTIVE: To evaluate the safety and efficacy of injectable PLLA injections for volume loss in the...BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable biostimulatory filler used for restoring facial fat volume loss. OBJECTIVE: To evaluate the safety and efficacy of injectable PLLA injections for volume loss in the temples using dual plane injections. Assessments included live ratings and ratings of standardized pictures and ultrasound imaging at weeks 4, 8, 12, and 16 by a trained evaluator. RESULTS: At the 8-week follow-up, there was a statistically significant increase in temporal volume and improvement in skin elasticity in PLLA-treated subjects. Treatment was well-tolerated with minimal self-resolving adverse effects. Ultrasound imaging confirmed that the injection plane was free of vasculature, posing no safety risk. CONCLUSION: Repeated PLLA treatments in the temporal region elicited a global improvement in facial shape, particularly the mid and upper face region. The temple hollowness and facial laxity improved over time with no safety sequelae.
BACKGROUND/OBJECTIVES: Melasma and age spots are among the most persistent and difficult-to-treat forms of hyperpigmentation. While traditional therapies offer some clinical efficacy, they often carry risks of irritation...BACKGROUND/OBJECTIVES: Melasma and age spots are among the most persistent and difficult-to-treat forms of hyperpigmentation. While traditional therapies offer some clinical efficacy, they often carry risks of irritation and rebound pigmentation. This study aims to evaluate the therapeutic potential and user tolerability of nanodiamond-zinc oxide (ND-ZnO)-containing skin preparations in improving hyperpigmentation conditions through 11 individual case series and 32 user-reported outcomes. METHODS: We analyzed 11 real-world case studies involving daily usage of ND-ZnO-containing cream and serum over a period of 4 to 12 weeks. Participants varied in age, ethnicity, and Fitzpatrick skin type (FST). Cases were selected based on adherence, diversity of presentation, and completeness of photographic and evaluative documentation. RESULTS: All 11 case participants demonstrated visible improvements in hyperpigmentation, with varying degrees of reduction in melasma and age spots. Among 32 questionnaire respondents, 90.63% reported a visible reduction in hyperpigmentation, 96.9% noted brighter and more even skin tone, and 93.75% observed improved radiance. All participants tolerated the treatment well, with 100% non-irritation confirmed by two separate Human Repeat Insult Patch Test (HRIPT) studies. CONCLUSIONS: ND-ZnO-containing skin preparations offer a well-tolerated and effective alternative to conventional treatments for melasma and age spots. Their multi-action approach, which combines UV protection, reactive oxygen species (ROS) scavenging, and enhanced delivery of actives, supports both prevention and repair of pigmentation. These findings suggest ND-ZnO formulations may serve as a safer and more compliant option for long-term hyperpigmentation management.  .
BACKGROUND: Juvéderm Volbella distinguishes itself for being the only hyaluronic acid filler with dual FDA approval for perioral and infraorbital regions. Its Vycross technology formulation and use in high-risk va...BACKGROUND: Juvéderm Volbella distinguishes itself for being the only hyaluronic acid filler with dual FDA approval for perioral and infraorbital regions. Its Vycross technology formulation and use in high-risk vascular areas necessitate a comprehensive real-world safety analysis to inform clinical practice. OBJECTIVE: To evaluate and categorize adverse events associated with Juvéderm Volbella injections using the Manufacturer and User Facility Device Experience (MAUDE) database, focusing on injection sites and the number of treated areas. METHODS AND MATERIALS: Adverse event reports from January 2020 to January 2024 were reviewed and graded using standardized criteria. Events were grouped by injection site, number of anatomical areas injected, and time of symptom onset. Statistical analyses included chi-square and Kruskal-Wallis tests. RESULTS: Among 315 patients, dermatologic and vascular events predominated, with higher vascular complication rates following perioral injections. Severe adverse events (CTCAE >2) occurred at a median of 75 days postinjection versus 51 days for moderate events. Perioral injections required antibiotics in 53.3% of severe cases versus 28.6% of mild cases (P=0.0003). CONCLUSION: Perioral Volbella injections demonstrate increased vascular complication risks requiring modified clinical protocols: extended follow-up schedules (2-3 months versus standard 2 weeks), enhanced informed consent, and site-specific risk stratification. These findings provide immediate, actionable evidence for improving patient safety through evidence-based practice modifications.  .
BACKGROUND: Topical efinaconazole 10% solution has demonstrated efficacy and safety in two phase 3 trials of onychomycosis. As clinical data for onychomycosis treatments are limited in patients with skin of color, this p...BACKGROUND: Topical efinaconazole 10% solution has demonstrated efficacy and safety in two phase 3 trials of onychomycosis. As clinical data for onychomycosis treatments are limited in patients with skin of color, this post hoc analysis evaluated efinaconazole in participants categorized by race. METHODS: Data were pooled from 2 multicenter, double-blind, phase 3 trials (NCT01007708, NCT01008033). Participants aged 18 to 70 years with mild-to-moderate distal lateral subungual onychomycosis in ≥1 great toenail were randomized (3:1) to once-daily efinaconazole or vehicle for 48 weeks. Efficacy endpoints at week 52 included rates of mycologic cure (MC; negative potassium hydroxide examination + negative fungal culture), complete cure (0% clinical involvement + MC), complete/almost complete cure (≤5% clinical involvement + MC), and clinical efficacy (<10% clinical involvement). Adverse events (AEs) were assessed. RESULTS: Participants (n=1655) were categorized by self-reported race: White (n=1251), Asian (n=269), or Black (n=98). At week 52, more efinaconazole- vs vehicle-treated participants achieved complete cure (White, 14.7% vs 2.0%; Asian, 27.5% vs 13.0%; Black, 12.9% vs 7.1%), complete/almost complete cure (22.8% vs 4.6%; 35.5% vs 18.8%; 25.7% vs 7.1%), and clinical efficacy (31.2% vs 8.6%; 46.0% vs 23.2%; 31.4% vs 21.4%). Mycologic cure rates were also higher with efinaconazole (range: 53.4%–61.4%) vs vehicle (10.7%–30.4%). Most treatment-emergent AEs with efinaconazole were mild/moderate, with low discontinuation rates (<6%). CONCLUSIONS: Topical efinaconazole 10% showed favorable efficacy/safety in White, Asian, and Black participants with mild-to-moderate onychomycosis. Results were generally consistent with the overall phase 3 populations and position efinaconazole as an efficacious treatment for patients, regardless of race.  .
BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly prescribed for conditions beyond type 2 diabetes, including psoriasis and hidradenitis suppurativa. Despite this, little is known about t...BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly prescribed for conditions beyond type 2 diabetes, including psoriasis and hidradenitis suppurativa. Despite this, little is known about their dermatologic safety profiles. METHODS: We analyzed FDA Adverse Event Reporting System (FAERS) data from 2018 to 2024 for semaglutide, liraglutide, exenatide, and dulaglutide. Cutaneous adverse events (AEs) were identified using MedDRA-coded terms: "rash," "pruritus," "urticaria," "alopecia," and "angioedema". Frequency and proportional reporting ratios (PRRs) were calculated using dipeptidyl peptidase-4 (DPP-4) inhibitors as a comparator. Logistic regression assessed predictors of cutaneous AEs, with dulaglutide as a reference and sex, age, and GLP-1 RA type as independent variables. RESULTS: Cutaneous AEs were reported in up to 8.16% of GLP-1 RA cases, more often in females, with a mean patient age of 60. Semaglutide was associated with the highest rate, and dulaglutide the lowest. PRR analysis (0.27; 95% CI: 0.257-0.284) showed these AEs were proportionally less common relative to DPP-4 inhibitor users. Exenatide was associated with increased odds (OR = 5.01, 95% CI: 4.69–5.35), while liraglutide and semaglutide showed decreased odds. DISCUSSION: Possibly influenced by dosage, immune modulation, and patient perception of efficacy, cutaneous GLP-1RA adverse effects were less frequent than DPP-4 inhibitors, but still warrant clinician awareness. These reactions might impact patient adherence, which highlights the need for further investigation into their mechanisms. CONCLUSION: Cutaneous AEs are infrequent but vary by GLP-1 RA. Greater awareness may improve patient counseling as indications expand.  .
BACKGROUND: A new multimodal skin tone correcting serum formulated with b.r.y.t.e.r. (brown, red, and yellow tones with enhanced resurfacing) technology (EV-I) targets brown, red, and yellow dyschromia and acts through 5...BACKGROUND: A new multimodal skin tone correcting serum formulated with b.r.y.t.e.r. (brown, red, and yellow tones with enhanced resurfacing) technology (EV-I) targets brown, red, and yellow dyschromia and acts through 5 pathways of melanin synthesis to reduce pigmentation, resurface and exfoliate skin, and improve overall skin tone. METHODS: A single-center, open-label, 12-week trial enrolled females with mild-to-severe dyschromia/hyperpigmentation. EV-I was applied twice daily for 12 weeks, with a subset of participants also applying a double-conjugated retinoid/AHA cream (AHARet) nightly. Pigmentation was graded using the Melasma Area and Severity Index (MASI) scale at baseline and at weeks 2, 4, 8, and 12. Skin dullness and texture were assessed using a 6-point grading scale. Erythema and dryness/flaking were assessed using a 4-point grading scale. Participant satisfaction and adverse events (AEs) were collected over 12 weeks. RESULTS: Sixty-five participants were enrolled (EV-I, n=40; EV-I/AHARet, n=25) with a mean age of 53 years; 78% of participants had Fitzpatrick skin types (FST) I-III, 22% were FST IV-VI. The majority of participants presented with moderate-to-severe dyschromia/hyperpigmentation. Significant percent improvements from baseline were demonstrated based on MASI scores at 12 weeks (EV-I, 42%, EV-I/AHARet, 47% [all, P<.0001]). Significant improvements from baseline were demonstrated in the appearance of skin texture (EV-I, 46%; EV-I/AHARet, 59% [all, P<.0001]) and dullness (EV-I, 47%; EV-I/AHARet, 59% [all, P<.0001]) at 12 weeks. No increases in erythema or dryness/flaking were observed. CONCLUSIONS: A new multimodal skin tone correcting serum demonstrated significant improvements in MASI scores and in the appearance of skin texture and dullness. Significant improvements were also achieved in participants using both the skin tone correcting serum and double-conjugated retinoid/AHA cream. Participants reported high levels of satisfaction over 12 weeks.  .
BACKGROUND: Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. Thi...BACKGROUND: Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of available therapies within regenerative dermatology, outlining the pathways for approval. METHODS: Articles on regenerative dermatology in PubMed and guidelines issued by the United States Food and Drug Administration (FDA) were reviewed with emphasis on those published between June 2020 and June 2025, and results were summarized in narrative format. RESULTS: In the United States, the FDA is the primary regulatory authority responsible for ensuring the safety and efficacy of regenerative biotherapeutics. Classification of a product as a drug, biologic, device, or cosmetic determines the regulatory pathway it must follow. DISCUSSION: Cosmetics are intended to promote attractiveness without treating or preventing disease and do not require FDA approval prior to marketing, while drugs and biologics undergo a multi-step process to obtain approval: (1) product development, (2) preclinical testing in a laboratory setting, (3) clinical trials involving human subjects, (4) FDA review, and (5) FDA approval. High-risk devices require a Premarket Approval (PMA), while low-to-moderate risk devices have less stringent requirements. CONCLUSION: Regenerative dermatology offers significant therapeutic potential. Regulation is governed by the US FDA and varies according to product classification. Clinicians should counsel patients on safety and efficacy data prior to initiating regenerative treatments.  .
BACKGROUND: Atopic dermatitis (AD) disproportionately affects diverse patient populations, and complex factors influence access to treatment among different racial and ethnic groups. OBJECTIVE: This study aimed to assess...BACKGROUND: Atopic dermatitis (AD) disproportionately affects diverse patient populations, and complex factors influence access to treatment among different racial and ethnic groups. OBJECTIVE: This study aimed to assess racial and ethnic differences in AD severity and access to treatment in clinical practice. METHODS: The study included patients aged 6 and older with AD enrolled in TARGET-DERM AD, an observational, longitudinal study utilizing electronic medical records from 43 academic and community centers across the United States. RESULTS: The analysis included 1,928 participants: 577 children (30%) and 1,351 adults (70%), with 42% identifying as Non-White. Non-Hispanic (NH) Asian participants exhibited the highest percentage of moderate-to-severe AD at 63%, followed by NH-Black (61%), Hispanic (49%), and NH-White (48%) participants. Over half (56%) of NH-Asian patients reported comorbid asthma. NH-Black and Hispanic individuals were less likely to receive advanced systemic therapies compared to NH-White individuals, with odds ratios of 0.71 and 0.66, respectively, both statistically significant (P<0.01). CONCLUSION: Despite having moderate-to-severe AD, NH-Black and Hispanic patients had significantly lower odds of receiving advanced systemic therapy compared to NH-White patients, highlighting potential disparities in access to advanced treatments for AD.  .
BACKGROUND: Hyperpigmentation disorders are common skin concerns that negatively impact patient quality of life and self-perception. Hyperpigmentation results from the overproduction of melanin via a multi-step process w...BACKGROUND: Hyperpigmentation disorders are common skin concerns that negatively impact patient quality of life and self-perception. Hyperpigmentation results from the overproduction of melanin via a multi-step process with a rate-limiting step catalyzed by tyrosinase. Thiamidol, an effective human tyrosinase inhibitor, has recently been shown to reduce visible signs of hyperpigmentation and could provide additional benefits when combined with the standard of care treatment for hyperpigmentation: photoprotection, specifically sunscreens with sun protection factor (SPF). METHODS: A randomized study was performed with 95 subjects (n=47, Thiamidol regimen; n=48, standard SPF 30 lotion) aged 18–65 clinically presenting with facial hyperpigmentation (measured by colorimeter and individual typology angle [ITA°]) to assess the efficacy of the Thiamidol-containing regimen (Day Lotion with SPF 30 and Serum applied in the morning, Night Cream and Serum applied in the evening) compared with a standard SPF 30 lotion for 12 weeks, followed by a 6-week regression phase. RESULTS: Facial hyperpigmentation, measured by skin lightness, ITA° values, radiance, and shine, was significantly reduced relative to baseline for both groups as early as week 2, and significantly reduced for patients receiving the Thiamidol-containing regimen vs the standard SPF 30 lotion at weeks 8 and 12. DISCUSSION: This study demonstrates that while SPF alone can reduce the visible signs of hyperpigmentation, the addition of Thiamidol to a daily skin care regimen confers additional, durable benefits with regard to skin lightness, radiance, and shine. CONCLUSION: These data support the integration of Thiamidol-containing formulations into existing skin regimens for individuals with facial hyperpigmentation.  .
BACKGROUND: Previous studies have documented the capacity of malassezin to brighten the skin. It represents a novel agent for the treatment of hyperpigmentation. OBJECTIVE: To compare the efficacy and safety of a topical...BACKGROUND: Previous studies have documented the capacity of malassezin to brighten the skin. It represents a novel agent for the treatment of hyperpigmentation. OBJECTIVE: To compare the efficacy and safety of a topical 0.75% malassezin formulation to 4% hydroquinone, the gold standard for treating melasma. METHODS: A randomized, controlled, split-face, double-blind study was conducted in 20 adult female subjects with symmetrical mild-to-moderate melasma. Subjects were randomized 1:1 to determine the allotted side of the face treated twice per day with malassezin or hydroquinone for 12 weeks. Treatment efficacy was evaluated by measuring brightening effects, global improvement, split-face Melasma Area Severity Index (hemi-MASI) scores, colorimetry measurements, and photography. RESULTS: Twenty subjects completed the study. Compared to baseline, both malassezin and hydroquinone-treated facial areas showed significant efficacy at 12 weeks in brightening (1.85 and 1.95, P=0.027 and 0.008); global improvement (2.2 and 2.3, P=0.004 and 0.001); and hemi-MASI reduction (2.49 and 2.33; P<0.001 and P<0.001), respectively. However, there were no statistically significant differences when comparing the malassezin-treated side to the hydroquinone-treated side at each visit. Side effects in both groups were mild throughout the study. CONCLUSION: These findings suggest that malassezin shows comparable efficacy to the gold standard, hydroquinone. Our results further support malassezin as a promising new treatment for patients with melasma.  .