BACKGROUND: Janus kinase inhibitors (JAKis) can improve hair regrowth in alopecia areata (AA). OBJECTIVE: This study examined which treatment attributes patients value most when evaluating hypothetical JAKi-based therapi...BACKGROUND: Janus kinase inhibitors (JAKis) can improve hair regrowth in alopecia areata (AA). OBJECTIVE: This study examined which treatment attributes patients value most when evaluating hypothetical JAKi-based therapies. METHODS: A discrete choice experiment was conducted among adults with ≥50% hair loss, recruited through the National Alopecia Areata Foundation (February-March 2024). Participants completed 10 binary choices comparing three hypothetical JAKi attributes: proportion with scalp hair regrowth, time to initial hair regrowth, and dosing frequency; safety attributes were held constant across profiles because the safety profiles were similar among JAKis approved for AA. Relative importance (RI) was calculated using preference weights. Additionally, participants ranked three blinded treatment profiles developed from phase 2b-3 data: drug profile A (baricitinib 4 mg), drug profile B (ritlecitinib 50 mg), and drug profile C (deuruxolitinib 8 mg). RESULTS: Among 302 patients (85% women, 81% White, mean age 43.2 years), the most valued attribute was scalp regrowth (RI = 60.0%), followed by time to initial regrowth (28.2%) and dosing frequency (11.7%). Drug profile C was most preferred (83%), and drug profile B was least preferred (85%). CONCLUSION: When considering efficacy only, patients prioritize higher efficacy and faster time to hair regrowth above dosing convenience in JAKi treatment preferences for AA.
Simpson EL, Prajapati VH, Bunick CG
… +11 more, Chovatiya R, Gold LFS, Figueras Nart I, Calimlim B, Grada A, Pechonkina A, Li C, Truong B, Hu X, Armendariz Y, Katoh N
OBJECTIVES: Atopic dermatitis (AD), a chronic, immune-mediated inflammatory disease, is characterized by intense itch, eczematous rash, and skin pain, which can have negative impacts to quality-of-life (QoL), sleep, and...OBJECTIVES: Atopic dermatitis (AD), a chronic, immune-mediated inflammatory disease, is characterized by intense itch, eczematous rash, and skin pain, which can have negative impacts to quality-of-life (QoL), sleep, and mental health (especially anxiety and depression). Evaluation of the impacts of AD on the patient's lived experience are most accurately assessed by the patient, making measures of patient-reported outcomes (PROs) indispensable. The objective of the current study was to assess the long-term impact of upadacitinib, a once-daily oral selective Janus kinase inhibitor approved for the treatment of moderate-to-severe AD, on patient-reported outcomes, providing a comprehensive in-depth evaluation of results of patient experience across multiple domains. METHODS: Using integrated data from the Measure Up 1 & 2 trials, the current study characterizes the efficacy of upadacitinib on several measures that assess the impact of AD on patients' lives, including patient-reported disease and symptom severity, sleep, emotional well-being, daily activities, QoL, and treatment satisfaction. RESULTS: Results demonstrated that rapid improvements in PRO measures of itch, sleep, daily activities, QoL, and emotional well-being reported at week 16 and week 52 were sustained or further improved at week 140 for patients with moderate-to-severe AD continuing upadacitinib 15 mg or 30 mg therapy, with no new safety signals observed. CONCLUSIONS: These findings support upadacitinib as a long-term treatment option to improve patient-reported burdensome symptoms of AD across 140 weeks of exposure.
BACKGROUND: Pulsed dye laser (PDL) is widely used for erythematotelangiectatic rosacea (ETR); however, the influence of pulse duration remains unclear. OBJECTIVE: To compare the efficacy and tolerability of 6 and 10 ms P...BACKGROUND: Pulsed dye laser (PDL) is widely used for erythematotelangiectatic rosacea (ETR); however, the influence of pulse duration remains unclear. OBJECTIVE: To compare the efficacy and tolerability of 6 and 10 ms PDL pulse durations for ETR. METHODS: In this single-center, prospective, randomized controlled study, 80 patients with ETR received single PDL treatment using either a 6 or 10 ms pulse duration (9-11 J/cm, 7 mm spot size). Erythema was assessed by blinded dermatologists using the Clinical Erythema Assessment (CEA) and telangiectasia scores, and Rosacea Area and Severity Index (RASI). ImageJ analysis measured the Relative Intensity of Redness (RIR) and Percentage of Erythema Area (PEA). Adverse events were recorded on days 3 and 7, and patient global assessment (PGA) and symptom improvement were evaluated at week 4. RESULTS: Both groups showed significant improvements in CEA, RASI, RIR, and PEA ( < 0.001), with no significant between group differences. However, edema ( < 0.05) and purpura ( < 0.001) were more frequent with the 6 ms setting. No significant differences were observed between the groups on the PGA, erythema improvement scale, or symptom improvement scale. CONCLUSION: Both pulse durations effectively reduced erythema, but 10 ms demonstrated more favorable tolerability.
BACKGROUND: Dupilumab is highly effective in atopic dermatitis (AD) but is associated with ocular surface disease, whereas Janus kinase (JAK) inhibitors may have a more favorable ocular safety profile. OBJECTIVES: To com...BACKGROUND: Dupilumab is highly effective in atopic dermatitis (AD) but is associated with ocular surface disease, whereas Janus kinase (JAK) inhibitors may have a more favorable ocular safety profile. OBJECTIVES: To compare ocular outcomes and conjunctival microbiology in patients with moderate-to-severe AD treated with dupilumab versus upadacitinib. METHODS: In this prospective real-world study, adult patients were treated with dupilumab or upadacitinib and evaluated at baseline and after 16 weeks. Ocular assessment included the Ocular Surface Disease Index (OSDI) and Schirmer test. Conjunctival swabs were collected for culture. Dermatological outcomes were assessed using EASI and DLQI. RESULTS: Ninety-six patients were included (upadacitinib, = 52; dupilumab, = 44). Both treatments significantly improved EASI and DLQI. Conjunctivitis occurred in 39.0% of dupilumab-treated patients and in none of the upadacitinib-treated patients ( < .001). OSDI improved with upadacitinib (-8.3) but worsened with dupilumab (+2.1) ( < .001). Schirmer test results and bacterial colonization did not differ between groups. CONCLUSIONS: Dupilumab and upadacitinib showed comparable dermatological efficacy but distinct ocular safety profiles. Dupilumab was associated with more frequent conjunctivitis and worsening ocular symptoms.
Contente M, João AL, Luz M
… +10 more, Mendes-Bastos P, Roda Â, Leite L, Valério J, Ferreirinha A, Leal B, Paiva Lopes MJ, Pimenta R, Ferreira P, Torres T
OBJECTIVES: Plaque psoriasis frequently involves high-impact anatomical sites such as the scalp, nails, and palmoplantar regions, which are associated with significant functional impairment and reduced quality of life. E...OBJECTIVES: Plaque psoriasis frequently involves high-impact anatomical sites such as the scalp, nails, and palmoplantar regions, which are associated with significant functional impairment and reduced quality of life. Evidence on the long-term effectiveness of biologic therapies in these locations in real-world settings remains limited. This study aimed to evaluate the real-world effectiveness and safety outcomes of risankizumab in achieving complete clearance of psoriasis affecting high-impact sites over a 2-year period. METHODS: We conducted a retrospective multicenter cohort study including adult patients with plaque psoriasis who initiated risankizumab between January 2020 and December 2023 across six dermatology centers. Effectiveness was assessed as the proportion of patients achieving complete clearance (Physician Global Assessment score of 0) in scalp, nail, and palmoplantar psoriasis. RESULTS: Among 459 patients treated with risankizumab, 232 (50.5%) had involvement of at least one high-impact site at baseline. Complete clearance at 2 years was achieved in 72.5% of patients with scalp involvement, 64.7% of those with nail psoriasis, and 52.2% of those with palmoplantar disease. Adverse events were infrequent and not treatment-limiting. CONCLUSIONS: These findings support the effectiveness of risankizumab in high-impact psoriasis sites in real-world clinical practice.
UNLABELLED: is an emerging dermatophytic pathogen causing severe infections that are frequently resistant to standard antifungals. Since 2015, this species has spread intercontinentally. OBJECTIVES: To highlight the cli...UNLABELLED: is an emerging dermatophytic pathogen causing severe infections that are frequently resistant to standard antifungals. Since 2015, this species has spread intercontinentally. OBJECTIVES: To highlight the clinical characteristics and challenges in managing infections in the United States and to introduce the utility of rapid real-time PCR (qPCR) diagnosis. METHODS: Records from a molecular diagnostics laboratory (Bako Diagnostics, GA, USA) were retrospectively reviewed for detections between May 2025 and January 2026. Cases were identified using a novel single-plex qPCR assay and confirmed by sequencing of the internal transcribed spacer region. The squalene epoxidase gene () was sequenced to assess terbinafine resistance. A survey was distributed to treating physicians to collect information on recent international travel, household transmission, clinical features, immunosuppressive medications or conditions, and treatment history. RESULTS AND CONCLUSIONS: All patients (median age: 54; 3 males and 2 females) reported recent travel to India or Nepal, except one, who was the spouse of a patient who had traveled to India. Two different substitutions were detected, F397L ( = 2) and L393F ( = 1), which are common among terbinafine-resistant isolates found globally. Potential gaps in clinical management - attributed to treatment initiation prior to confirmatory diagnosis of - were identified. These gaps include the use of topical corticosteroids, lack of itraconazole use (100-200 mg/day for 6-8 weeks or longer) as first-line treatment, and prescribing fixed, short treatment durations. In cases, these practices may increase the risk of disease recurrence and domestic spread. Current clinical recommendations are summarized herein, highlighting the utility of this novel qPCR assay for real-time treatment decision-making.
OBJECTIVES: To report a case of AA developing during golimumab and leflunomide treatment for seropositive rheumatoid arthritis, with subsequent improvement following initiation of selective Janus kinase 1 (JAK1) inhibiti...OBJECTIVES: To report a case of AA developing during golimumab and leflunomide treatment for seropositive rheumatoid arthritis, with subsequent improvement following initiation of selective Janus kinase 1 (JAK1) inhibition. METHODS: A 55-year-old woman developed progressive, non-scarring alopecia while rheumatoid arthritis disease activity remained well controlled. Clinical and trichoscopic findings were consistent with AA, and laboratory investigations were unremarkable. The patient received serial intralesional triamcinolone at approximately 4-8 week intervals over a 14-month period, with progression in Severity of Alopecia Tool (SALT) score from approximately 20 to 50. Alopecia developed and progressed despite ongoing TNF-α inhibitor therapy and serial intralesional corticosteroids. Upadacitinib was initiated for rheumatoid arthritis management and escalated from 15 mg to 30 mg. RESULTS: Hair regrowth was observed within six weeks, with SALT improving to approximately 15 by three months. CONCLUSIONS: Although spontaneous remission and delayed corticosteroid effects cannot be excluded, the timing and magnitude of improvement support a temporal association with JAK1 inhibition. This case highlights a pragmatic therapeutic consideration when alopecia arises during TNF-α inhibitor therapy.
Batool A, Abbas MS, Ali Akbar M
… +10 more, Murtaza M, Mahin FE, Ali U, Ahmed AB, Khattak MH, Fazal M, Maryam Z, Yaqoob R, Silva Correia JV, Aminpoor H
BACKGROUND: Acne vulgaris is a chronic inflammatory disease and is one of the leading causes of dermatological morbidities among young adults. Doxycycline is widely recommended as first-line therapy for moderate to sever...BACKGROUND: Acne vulgaris is a chronic inflammatory disease and is one of the leading causes of dermatological morbidities among young adults. Doxycycline is widely recommended as first-line therapy for moderate to severe acne; however, its use is limited. OBJECTIVE: To systematically compare the efficacy and safety of oral azithromycin pulse therapy versus doxycycline in patients with moderate to severe acne vulgaris. METHODS: This systematic review and meta-analysis followed PRISMA guidelines. A comprehensive literature search on different databases was performed. Two reviewers independently screened studies, extracted data, and assessed risk of bias. Mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models based on heterogeneity. RESULTS: A total of 23 comparative studies comprising 2,769 patients were included. Pooled analysis demonstrated a statistically significant improvement in global acne severity favoring azithromycin (GAGS reduction: MD 1.81; 95% CI 1.28-2.34; I = 0%). Azithromycin achieved a significantly greater reduction in non-inflammatory lesion counts (MD -7.56; 95% CI -14.33 to -0.79). No significant differences were observed in inflammatory lesion reduction (MD 1.08; 95% CI -0.03 to 2.18). CONCLUSION: Oral azithromycin pulse therapy appears to have similar efficacy, better tolerability, and fewer side effects as compared to doxycycline.
BACKGROUND/AIM: Second-generation immunomodulating drugs for inflammatory dermatoses have expanded over the past decades. Contraindications and special warnings must be considered before starting any treatment, but ident...BACKGROUND/AIM: Second-generation immunomodulating drugs for inflammatory dermatoses have expanded over the past decades. Contraindications and special warnings must be considered before starting any treatment, but identifying all relevant safety information can be time-consuming. The objective is to provide an overview of contraindications, special warnings, and boxed warnings with the aim to establish a safety checklist, covering second-generation immunomodulatory therapies. METHODS: We identified contraindications, special warnings and boxed warnings provided by the European Medicines Agency and the US Food and Drug Administration, for second-generation immunomodulating drugs approved for inflammatory dermatoses. Both topical and systemic therapies were included. RESULTS: Most drug classes had warnings related to infections. Herpes zoster was listed for anti-CD20, IL-12/23i, INFi, JAKi and TYK2i, where hepatitis reactivation was reported for anti-CD20, TNFi, IL-17i, anti-BAFF, JAKi and TYK2i. Malignancy risk including skin cancer was mentioned for most classes, except IL-23i, IL-17i, IL-13i, IL-4/13i, IL-31i, IL-36i and PDE4i. Other serious warnings included neurological, cardiovascular, thrombotic, hepatic, renal, gastrointestinal, and psychiatric adverse events. CONCLUSION: This work provides a simple stepwise approach to managing contraindications and special warnings. Our safety checklist gives clinicians a rapid overview of contraindications, special warnings, and boxed warnings for the available drug classes approved for inflammatory dermatoses.
PURPOSE/AIM OF THE STUDY: Oral doxycycline (DOX) is a first-line systemic therapy for rosacea; however, persistent vascular features, such as fixed erythema and flushing, and neurosensory symptoms, such as burning, may r...PURPOSE/AIM OF THE STUDY: Oral doxycycline (DOX) is a first-line systemic therapy for rosacea; however, persistent vascular features, such as fixed erythema and flushing, and neurosensory symptoms, such as burning, may respond incompletely to DOX alone. This study aimed to evaluate whether adding microneedling to oral DOX improves clinical outcomes in patients with rosacea. MATERIALS AND METHODS: This retrospective comparative cohort study included 160 patients with clinically confirmed rosacea. Patients received either 12 weeks of oral DOX monotherapy at 100 mg/day (control group, = 80) or the same DOX regimen combined with three monthly microneedling sessions (intervention group, = 80). The primary endpoint was the treatment success rate for facial erythema at week 12. Secondary outcomes included improvement in inflammatory papulopustular lesions, flushing, capillary dilation, swelling, burning sensations, quality of life, 6-month erythema relapse rate, and safety. RESULTS: At week 12, the intervention group showed a significantly higher treatment success rate for facial erythema than the control group (57.5% vs. 25.0%, < 0.001). Improvement in inflammatory papulopustular lesions was substantial in both groups but did not differ significantly between them (75.0% vs. 70.0%, = 0.478). Compared with DOX monotherapy, combination therapy produced significantly greater improvements in flushing, capillary dilation, swelling, burning sensations, and overall quality of life (all < 0.01). The 6-month erythema relapse rate was also markedly lower in the intervention group than in the control group (20.0% vs. 68.4%, < 0.001). No severe adverse events were observed. CONCLUSIONS: Adding microneedling to oral DOX was associated with greater improvement in vascular and neurosensory manifestations of rosacea, particularly facial erythema, flushing, and burning sensations. The combination approach also reduced erythema relapse at 6 months and was well tolerated.
BACKGROUND: Non-scarring alopecia, including androgenetic alopecia, alopecia areata, and telogen effluvium, is highly prevalent and often associated with significant psychosocial burden. Although treatments such as minox...BACKGROUND: Non-scarring alopecia, including androgenetic alopecia, alopecia areata, and telogen effluvium, is highly prevalent and often associated with significant psychosocial burden. Although treatments such as minoxidil and finasteride are available, variability in response and tolerability concerns have increased interest in alternative therapeutic approaches. Polyphenolic compounds have attracted attention due to their antioxidant, anti-inflammatory, and immunomodulatory properties. OBJECTIVES: This systematic review and meta-analysis evaluated the efficacy of oral and topical polyphenolic interventions for hair regeneration in adults with non-scarring alopecia. METHODS: A systematic search of PubMed/MEDLINE, Scopus, Web of Science, and Cochrane CENTRAL was conducted according to PRISMA 2020 guidelines (PROSPERO: CRD420251230149). Randomized, blinded controlled trials were included. Primary outcomes were objective trichoscopic measures, including hair density and total area hair count. RESULTS: Thirty-two randomized controlled trials involving 2,183 participants were analyzed. Compared with controls, polyphenolic interventions significantly improved hair density (SMD 0.90; 95% CI 0.51-1.30) and total area hair count (SMD 1.03; 95% CI 0.42-1.63), although substantial heterogeneity was observed. Direct comparisons with minoxidil did not show significant differences in overall hair count outcomes. CONCLUSIONS: Current evidence suggests that selected polyphenolic formulations may represent a potential adjunctive therapeutic approach in non-scarring alopecia, though further standardized and long-term trials are warranted.
PURPOSE: Hidradenitis suppurativa (HS) is a debilitating, chronic, inflammatory disease. While secukinumab (an IL-17A inhibitor) demonstrates systemic efficacy, specific lesions often remain resistant to systemic therapy...PURPOSE: Hidradenitis suppurativa (HS) is a debilitating, chronic, inflammatory disease. While secukinumab (an IL-17A inhibitor) demonstrates systemic efficacy, specific lesions often remain resistant to systemic therapy, representing a significant unmet clinical need. This case series aimed to evaluate the efficacy and safety of intralesional secukinumab for localized HS lesions. MATERIALS AND METHODS: We retrospectively analyzed five patients treated with this modality after failing conventional therapies, including oral tetracyclines and oral/intralesional corticosteroids. RESULTS: Post-treatment, all targeted lesions showed marked reduction in inflammation and nodule size. Notably, patient-reported Visual Analogue Scale (VAS) and Dermatology Life Quality Index (DLQI) scores decreased rapidly in the short term. No severe local adverse events or systemic side effects were observed. CONCLUSIONS: These preliminary findings suggest that intralesional secukinumab may serve as an effective, well-tolerated adjunctive strategy, particularly for localized, recalcitrant lesions, offering a new perspective in HS management.
BACKGROUND: Comparative studies among different autologous platelet concentrate types for FPHL remain lacking. METHODS: Patients with FPHL (Sinclair gradeII-III) were enrolled and randomized to receive 4 sessions of PRP,...BACKGROUND: Comparative studies among different autologous platelet concentrate types for FPHL remain lacking. METHODS: Patients with FPHL (Sinclair gradeII-III) were enrolled and randomized to receive 4 sessions of PRP, i-PRF or CGF treatment at 4-week intervals. The primary endpoint was the inter-group comparison of the non-vellus target area hair count (TAHC)-increase (%) at 24 weeks. Secondary endpoints included: within-group changes in TAHC from baseline; within-group changes in hair diameter (HD) from baseline and inter-group comparison of HD-increase (%) at 24 weeks; Growth factor concentrations were quantified to explore correlations with efficacy. RESULTS: Seventy-four patients completed the study. Post-treatment TAHC increased significantly from baseline in all groups (all < 0.05). The TAHC-increase(%) was significantly greater in the CGF (27.11 ± 14.80%) and i-PRF (26.54 ± 11.46%) groups compared to the PRP group (14.53 ± 8.65%; < 0.05), with no significant difference between CGF and i-PRF. Regarding HD increase, all three groups showed improvement, with no statistically significant differences observed among groups ( > 0.05). The i-PRF group showed the lowest adverse event rate. Vascular endothelial growth factor (VEGF) concentration demonstrated a significant positive correlation with the percentage increase in TAHC ( = 0.527, R=0.278, < 0.05). CONCLUSIONS: CGF and i-PRF demonstrated superior efficacy in increasing TAHC in FPHL patients. The i-PRF group had the lowest adverse event rate. VEGF levels may play a potential role in promoting hair growth.
OBJECTIVE: Patients with atopic dermatitis (AD) face an increasingly complex treatment landscape with prescription options that vary in efficacy, safety, and mode of administration. The aim of this study was to evaluate...OBJECTIVE: Patients with atopic dermatitis (AD) face an increasingly complex treatment landscape with prescription options that vary in efficacy, safety, and mode of administration. The aim of this study was to evaluate how real-world factors such as risk tolerance, side effect (SE) concerns, and disease control influence treatment decisions. METHODS: A cross-sectional electronic survey (January-April 2025) of U.S. adults with self-reported AD and caregivers was conducted to assess how they weigh treatment benefits and risks. Negative binomial regression examined predictors of the number of SEs prioritized over rapid symptom relief when AD is at its worst. RESULTS: Included respondents (796 adults, 113 caregivers) most frequently reported unknown long-term SEs (618; 68.0%), liver or kidney problems (610; 67.1%), and allergic reactions (538; 59.2%) as SEs of concern. Over one quarter (26.1%) prioritized avoidance of ≥5 SEs over rapid symptom relief. Caregivers prioritized 40% more SEs over rapid relief than adult patients (adj IRR, 1.40; 95% CI, 1.22-1.61). Higher willingness to take health-related risks was associated with prioritizing fewer SEs (adj IRR, 0.95; 95% CI, 0.93-0.96), but AD control status was not significantly associated with SE prioritization. CONCLUSION: These findings demonstrate that safety concerns strongly influence treatment decision-making in AD, underscoring the need for transparent, personalized discussions to support shared decision-making.
BACKGROUND: Pruritus is a debilitating symptom and conventional therapies often provide incomplete relief. The μ-opioid receptor (MOR) pathway is a key regulator of itch, and μ-pathway-modulating agents are increasingly...BACKGROUND: Pruritus is a debilitating symptom and conventional therapies often provide incomplete relief. The μ-opioid receptor (MOR) pathway is a key regulator of itch, and μ-pathway-modulating agents are increasingly used off-label for refractory pruritus. AIM: This systematic review evaluates the efficacy, safety, and real-world use of μ-opioid pathway modulators for pruritus of dermatologic and systemic origin. METHODS: Following PRISMA guidelines (PROSPERO CRD420251207101), a comprehensive search of four databases identified 3,274 records, of which 69 studies met inclusion criteria, comprising 14 randomized controlled trials (RCTs; = 795) and 55 non-randomized studies ( = 351). Owing to substantial clinical and methodological heterogeneity, findings were narratively synthesized. RESULTS: Five RCTs evaluated dermatologic conditions, including atopic dermatitis, prurigo nodularis, chronic urticaria, and lichen planopilaris, while nine RCTs assessed systemic pruritus, predominantly cholestatic and uremic pruritus. RCTs investigated oral or topical naltrexone, intravenous naloxone, nalmefene, and extended-release nalbuphine, with most demonstrating clinically meaningful reductions in pruritus intensity using validated itch scales. Non-randomized studies reported improvement across a wide range of dermatologic and systemic conditions, with adverse events generally mild and well tolerated. CONCLUSIONS: Overall, μ-opioid pathway modulators show promising efficacy with acceptable short-term safety across diverse pruritic conditions, although larger high-quality RCTs are required to define optimal dosing and support clinical translation.
BACKGROUND: Oral lichen planus (OLP) is a chronic T-cell-mediated inflammatory mucocutaneous disorder with limited evidence on topical tacrolimus efficacy in subgroups based on cutaneous involvement. METHODS: This single...BACKGROUND: Oral lichen planus (OLP) is a chronic T-cell-mediated inflammatory mucocutaneous disorder with limited evidence on topical tacrolimus efficacy in subgroups based on cutaneous involvement. METHODS: This single-center retrospective cohort study analyzed data (2019-2024) from 120 biopsy-confirmed OLP patients after propensity score matching. Patients were classified according to treatment with topical tacrolimus 0.1% gel or clobetasol propionate 0.05% gel and stratified by cutaneous involvement. Primary outcomes included 8-week changes in visual analog scale (VAS) pain and total atrophic area (TAA), analyzed using mixed-effects models. RESULTS: Patients with cutaneous involvement exhibited higher baseline severity ( < 0.01). Tacrolimus use was associated with significant reductions in VAS (-1.2; 95% CI -1.7 to -0.7) and TAA (-1.0; 95% CI -1.4 to -0.6) compared to controls. The response rate was superior in the tacrolimus group (OR 3.2; 95% CI 1.5-6.8; = 0.002). Notably, treatment effects were stronger in patients with cutaneous involvement (interaction < 0.05). Adverse events were mild and transient; the most common event was burning sensation. CONCLUSIONS: Topical tacrolimus was associated with improved short-term OLP outcomes and may be particularly useful as a second-line or steroid-sparing option in patients with concomitant cutaneous involvement.