A prospective, split-face, randomized controlled trial of intense pulsed light-photodynamic therapy for seborrhea.

BACKGROUND: Seborrhea poses a common cosmetic concern in adolescents and young adults, often accompanied by enlarged pores, and contributing to various skin conditions, including acne vulgaris and seborrheic dermatitis. At present, there is a lack of effective treatment for this problem, and the potential of photodynamic therapy (PDT) in reducing sebum remains inconclusive. OBJECTIVE: This exploratory, prospective, single-center, double-blinded, randomized split-face controlled trial aimed to compare the efficacy and safety of intense pulsed light-photodynamic therapy (IPL-PDT) versus IPL therapy for seborrhea. METHODS: Participants with seborrhea underwent 3 times of IPL treatment (590 nm, 15-17 J/cm2 based on patient's tolerance) for one hemifacial part and IPL-PDT treatment for the other. Follow-up assessment was conducted up to 8 weeks after the final treatment. RESULTS: Compared with single IPL treatment, IPL-PDT can significantly inhibit sebum secretion and decrease pore size. PDT group exhibited no additional damage to the skin barrier, with even lower transepidermal water loss (TEWL). Additionally, the PDT group showed superior improvement in scores of porphyrins, red areas, and ultraviolet (UV) spots. Both groups experienced only mild topical adverse effects, well tolerated by the participants. CONCLUSION: IPL-PDT is a more effective method than IPL in the treatment of seborrhea, as well as on the improvement of the skin barrier function.

Synergism Between Essential Oils and Evaluation of Their Activities with a Focus on Malassezia furfur Control.

Seborrheic dermatitis is a chronic inflammatory disease caused by Malassezia yeast species that affects the regions of the body where the sebaceous glands are present. The combined use of different essential oils (EOs) can increase their spectrum of action. Thus, the present study aimed to evaluate the action of EOs alone and in combination with each other on M. furfur, in planktonic and biofilm form, and their anti-inflammatory and mutagenic potential, in addition to the effects on the viability of cells lines. Of the 40 evaluated EOs, 22 showed activity against M. furfur at 0.5 - 2.0 mg/mL concentrations. Among the most active species, a blend of essential oils (BEOs) composed of Cymbopogon martini (Roxb.) Will. Watson (MIC = 0.5 mg/mL) and Mentha × piperita L. (MIC = 1.0 mg/mL) was selected, which showed a synergistic effect against yeast when evaluated through the checkerboard assay. The fungicidal activity was maintained by the addition of anti-inflammatory oil from Varronia curassavica Jacq. to BEOs. The BEOs also showed activity in the inhibition of biofilm formation and in the eradication of the biofilm formed by M. furfur, being superior to the action of fluconazole. Furthermore, it did not show mutagenic potential and did not interfere with the cell viability of both evaluated cell lines (HaCaT and BMDMs). TNF-α levels were reduced only by C. martini; however, this property was maintained when evaluating BEOs. BEOs had no effect on IL-8 levels. Thus, the BEOs may be indicated for alternative treatments against seborrheic dermatitis.

Diagnosis and Management of Common Inflammatory Skin Diseases in Older Adults.

Inflammatory skin conditions affect people of all ages, genders, and races. These common conditions are frequent causes of visits to the dermatologist. The geriatric population is often afflicted by these conditions because many are chronic and relapsing diseases. These inflammatory conditions include but are not limited to psoriasis, atopic dermatitis, contact dermatitis, seborrheic dermatitis, rosacea, and Grover disease. Chronic inflammatory skin conditions place a large burden on the health care system in the United States and have many associated comorbidities. This article discusses these inflammatory dermatoses that affect the geriatric population and common therapeutic options.

Evaluation of the effect of botulinum toxin injection in aggravating or improving seborrheic dermatitis symptoms: A prospective, single-arm clinical trial.

INTRODUCTION: Considering the proven therapeutic effect of botulinum toxin and the pathophysiology of seborrheic dermatitis, conflicting hypotheses have been put forward regarding the effect of injection of this toxin on the improvement or exacerbation of seborrheic dermatitis. Because of the lack of consistent studies investigating this relationship, we decided to conduct this study to investigate the effect of local botulinum toxin injection on sebum production and improvement or worsening of seborrheic dermatitis lesions. METHOD: This study was a prospective, single-arm clinical trial that involved the injection of botulinum toxin into 20 patients with complaints of skin wrinkles and simultaneous symptoms of seborrheic dermatitis. The trial was conducted at a dermatology clinic between March 2019 and March 2021. Two important characteristics of these patients were seborrheic dermatitis on the face or scalp and a referral for botulinum toxin injection to remove facial wrinkles. The Seborrheic Dermatitis Area and Severity Index (SDASI) was used to determine the severity of symptoms. RESULTS: In study of 20 patients with an average age of 40 years, despite the decrease in the average scores of all examined criteria of seborrheic dermatitis symptoms in study, 1 month after botulinum toxin injection, no significant effect of using this toxin was seen on the improvement of patients' symptoms (p value >0.05). CONCLUSION: Despite the emphasis of many studies on the effectiveness of botulinum toxin in reducing the activity of sebaceous glands, the use of botulinum toxin as a therapeutic modality for control the symptoms of seborrheic dermatitis is not suggested by this study. Conducting studies in which the location and technique of injection and the follow-up intervals of patients in them are based on the standard of other studies, are the suggestions made by comparing the results and method of the current study with other studies.

Part 1: Understanding the role of Malassezia spp. in skin disorders: Malassezia yeasts as commensal or pathogenic organisms of human and animal skin.

INTRODUCTION: Malassezia spp. are a group of lipid-dependent basidiomycetes yeasts acting as commensal organisms of the human and animal skin. However, under some not well-defined circumstances, these yeasts may switch to opportunistic pathogens triggering a number of skin disorders with different clinical presentations. The genus comprises of 18 lipid-dependent species with a variable distribution in the hosts and pathologies thus suggesting a host- and microbe-specific interactions. AREA COVERED: This review highlighted and discussed the most recent literature regarding the genus Malassezia as a commensal or pathogenic organisms highlighting Malassezia-associated skin disorders in humans and animals and their antifungal susceptibility profile. A literature search of Malassezia associated skin disorders was performed via PubMed and Google scholar (up to May 2023), using the different keywords mainly associated with Malassezia skin disorders and Malassezia antifungal resistance. EXPERT OPINION: Malassezia yeasts are part of the skin mycobiota and their life cycle is strictly associated with the environment in which they live. The biochemical, physiological, or immunological condition of the host skin selects Malassezia spp. or genotypes able to survive in a specific environment by changing their metabolisms, thus producing virulence factors or metabolites which can cause skin disorders with different clinical presentations.

Treatment with the Topical Antimicrobial Peptide Omiganan in Mild-to-Moderate Facial Seborrheic Dermatitis versus Ketoconazole and Placebo: Results of a Randomized Controlled Proof-of-Concept Trial.

Facial seborrheic dermatitis (SD) is an inflammatory skin disease characterized by erythematous and scaly lesions on the skin with high sebaceous gland activity. The yeast Malassezia is regarded as a key pathogenic driver in this disease, but increased Staphylococcus abundances and barrier dysfunction are implicated as well. Here, we evaluated the antimicrobial peptide omiganan as a treatment for SD since it has shown both antifungal and antibacterial activity. A randomized, patient- and evaluator-blinded trial was performed comparing the four-week, twice daily topical administration of omiganan 1.75%, the comparator ketoconazole 2.00%, and placebo in patients with mild-to-moderate facial SD. Safety was monitored, and efficacy was determined by clinical scoring complemented with imaging. Microbial profiling was performed, and barrier integrity was assessed by trans-epidermal water loss and ceramide lipidomics. Omiganan was safe and well tolerated but did not result in a significant clinical improvement of SD, nor did it affect other biomarkers, compared to the placebo. Ketoconazole significantly reduced the disease severity compared to the placebo, with reduced Malassezia abundances, increased microbial diversity, restored skin barrier function, and decreased short-chain ceramide Cer[NSc34]. No significant decreases in Staphylococcus abundances were observed compared to the placebo. Omiganan is well tolerated but not efficacious in the treatment of facial SD. Previously established antimicrobial and antifungal properties of omiganan could not be demonstrated. Our multimodal characterization of the response to ketoconazole has reaffirmed previous insights into its mechanism of action.

Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial.

Importance: Current topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety. Objective: To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk. Design, Setting, and Participants: This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020. Interventions: Once-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks. Main Outcomes and Measures: The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed. Results: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P < .001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (P < .001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam. Conclusions and Relevance: The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT04091646.

Maintenance effect of a once-weekly regimen of a Selenium Disulfide-based shampoo in moderate-to-severe scalp seborrheic dermatitis after initial treatment with topical corticosteroid/salicylic acid.

INTRODUCTION: Seborrheic dermatitis (SD) is a chronic, relapsing, inflammatory disorder of the head and trunk. OBJECTIVES: To explore the potential of a 1% Selenium disulphide (SeS2)-based shampoo to prevent relapses of scalp SD (SSD) following corticosteroid/salicylic acid (TCS/SA) treatment. MATERIALS & METHODS: After a 2-week treatment with TCS/SA, adult patients with moderate-to-severe SSD received either the SeS2-based shampoo or its vehicle for eight weeks in a randomized, double-blinded fashion. Visits took place at baseline, weeks 2, 6 and 10. SSD severity was assessed based on erythema, flakes and pruritus; patients assessed the severity of pruritus. Global investigator and patient satisfaction were assessed at week 10. RESULTS: Forty-eight adults were included. After four and eight weeks of post TCS/SA maintenance regimen, 8.1% and 16.7% in the SeS2, and 41.7% and 54.2% in the vehicle group relapsed, respectively. First median time-to-relapse in the vehicle group was 56 days; this was not reached for SeS2. After two weeks of TCS/SA, the prevalence of patients with no pruritus was 29.2% in the SeS2 group, and 41.7% in the vehicle group; it increased to 76.2% with SeS2 and to 57.1% with the vehicle at the end of the study. The clinical benefit of treatment with TCS/SCA was maintained in the SeS2 group only. Investigators and patients were highly satisfied with the efficacy of SeS2. Tolerance to SeS2 was excellent, with no reported adverse events. CONCLUSION: The SeS2-based shampoo significantly reduces the time-to-relapse of moderate-to-severe SSD flares. Its tolerance was excellent, with no reported adverse events.

Selenium Disulfide-based shampoo applied for 4 weeks significantly improves dandruff and seborrheic dermatitis.

Seborrheic Dermatitis (SD) is a chronic and relapsing inflammatory condition accompanied by erythema, flaking and itching. Dandruff is a milder form of SD. Selenium disulfide (SeS2) is beneficial in both conditions. OBJECTIVES: to assess the efficacy of SeS2-based shampoo in dandruff/SD. MATERIALS & METHODS: an international, multicenter, observational study was conducted in 1407 adult subjects. SeS2- based shampoo was used 2 to 3 times per week for 4 weeks. Clinical efficacy criteria included improvement of hair, flaking, erythema and irritation on a scale from 0 to 5; investigator satisfaction was assessed at month 3 from 0 to 10. The subjects rated the impact of their hair problem (0 to 5), efficacy and satisfaction with SeS2-based shampoo at month 3. Tolerance was assessed throughout the study. RESULTS: At baseline, 68.2% had a flake severity score of 3-5, 49.9% an erythema severity score of 3-5, and 46.2% an irritation severity score of 3-5; 28.2% were bothered and 41.5% were very bothered. At study end, SD/D had at least clearly improved in 89.6% of subjects. All clinical signs had significantly (p<0.001) improved. 95.6% of subjects reported less pruritus. Significantly fewer (15.4%, p<0.0001) subjects were still bothered. The overall subject satisfaction score was 8.9±1.4; 97.6% of investigators were satisfied or very satisfied. Tolerance was good or very good in 98.8% of subjects. CONCLUSION: A SeS2-based shampoo applied 2 to 3 times per week is efficient and well tolerated in dandruff and SD.

Efficacy and safety of oral isotretinoin in the treatment of moderate to severe seborrheic dermatitis: a retrospective study.

BACKGROUND AND OBJECTIVES: Seborrheic dermatitis is a common, chronic, and recurrent inflammatory skin disease. There are few studies on oral isotretinoin in the treatment of seborrheic dermatitis. The aim of this research was to analyze the efficacy and safety of oral isotretinoin in the treatment of patients with moderate to severe seborrheic dermatitis. METHODS: This was a retrospective study. All included patients were diagnosed as moderate to severe seborrheic dermatitis and treated with oral isotretinoin from January 2019 to December 2020. Symptom Scale of Seborrheic Dermatitis (SSSD) was used to evaluate the overall severity status of disease. RESULTS: A total of 48 patients with moderate to severe seborrheic dermatitis were enrolled, of which 26 patients were treated with oral isotretinoin at a dose of 20 mg/day, and 22 patients were treated with oral isotretinoin at a dose of 10 mg/day. The duration of treatment was 2.42 ± 0.98 months (range: 2-6 months). The absolute SSSD values were 10.63 ± 1.02 for all 48 patients, 10.95 ± 1.15 and 10.30 ± 1.11 for patients with a dose of 20 and 10 mg/day, respectively. At the endpoint, there were no significant difference in SSSD values between the two groups (2.21 ± 0.24 vs. 2.35 ± 0.46, P = 0.18). The patients were satisfied with the two treatment schemes, and the difference was not statistically significant (P = 0.78). The most common side effect was cheilitis; however, no serious adverse events occurred in either group. CONCLUSIONS: When considering efficacy and safety, oral isotretinoin can be used to treat patients with moderate to severe seborrheic dermatitis.

Seborrheic dermatitis: topical therapeutics and formulation design.

Seborrheic dermatitis (SD) is a common dermatological disorder with symptoms that include skin flaking, erythema and pruritus. This review discusses the topical products available for treating SD, which target several aspects of disease pathobiology, including cutaneous microbial dysbiosis (driven by Malassezia yeast), inflammation, sebum production and skin barrier disruption. Among the various treatments available, zinc pyrithione (ZnPT) based products that exhibit anti-fungal action are the market leaders. A skin compartment approach is presented here for combining ZnPT exposure information with threshold levels for anti-fungal efficacy and toxicity, overall providing a comprehensive picture of ZnPT therapeutics and safety. While Malassezia yeast on the surface are effectively targeted, yeast residing beyond the superficial follicle may not receive adequate ZnPT for anti-fungal effect forming the basis for skin re-colonisation. Levels entering systemic circulation from topical delivery are well below toxic thresholds, however the elevated zinc levels within the viable epidermis warrants further investigation. Strategies to improve formulation design can be broadly classified as influencing 1) topical delivery, 2) therapeutic bioactivity, 3) skin mildness, and 4) sensory attributes. Successful SD treatment ultimately requires formulations that can balance efficacy, safety, and consumer appeal.

Botulinum Toxin in the Oily Skin: Advantage of a Multi-Needle Device for a Controlled Release.

BACKGROUND: Oily skin is one of the most common dermatological complaints. With the obligation to use masks to protect themselves from the Covid-19 virus, the problem has become even more evident. One of the treatments proposed is the use of onabotulinumtoxin-A injected sub-dermally. For an optimal result, the injections must be done on the whole area with numerous micro-injections located only in the sub-dermis. The procedure is often poorly tolerated by patients and sometimes accompanied by hematomas and bruises. This research aimed to test a disposable device to inject botulin toxin at 1.5 mm under the skin with a painless procedure and homogeneous distribution of the toxin. METHODS: We treated patients with oily skin with the injection of 100 IU of Onabotulinumtoxin-A (diluted in 5 ml of a saline solution). All the patients were evaluated after 2 weeks, one month, and three months. RESULTS: In 10 patients, after 15 days we observed a real improvement of the quality of the skin; for two, the results were present at the 1 month follow up. In all cases, the treatment appeared homogeneous in the entire face. All the patients considered the procedure virtually painless or with minimal discomfort. CONCLUSION: In accordance with other authors, we confirm the real advantages of micro-botulinum toxin for oily skin. Moreover, the use of this simple and innovative device allows a homogeneous distribution of the drug in the correct plane, without pain, and reduces the risks of common complications. J Drugs Dermatol. 2023;21(1): doi:10.36849/JDD.6900.

Effectiveness of Sopoongsan for chronic upper body pruritus in patients with atopic or seborrheic dermatitis: A pilot study protocol for a randomized, double-blind, placebo-controlled, parallel trial.

INTRODUCTION: Chronic pruritus persists for > 6 weeks and is known to decrease patients' quality of life. Due to the complex pathological mechanism of chronic pruritus, there is still a lack of satisfactory therapeutic agents; therefore, complementary therapies are required to improve itching symptoms. In the Republic of Korea, Sopoongsan, an herbal formula, has been used to treat itching, dizziness, and skin paralysis. To our knowledge, this is the first study to evaluate whether Sopoongsan improves chronic pruritus and to identify Sopoongsan-related changes in the immune response in patients with chronic upper body pruritus. METHODS: A randomized, double-blind, placebo-controlled parallel trial will be conducted to assess 20 patients with chronic upper body pruritus for 3 months who have been diagnosed with allergic atopic dermatitis or seborrheic dermatitis. The patients will be randomly allocated to either the placebo-control (n = 10) or treatment (n = 10) group. The total study period will be 8 weeks (i.e., administration of Sopoongsan or placebo drugs for 4 wk and follow-up for 4 wk). Participants will be allowed to receive external treatment, except for antipruritic medications administered orally, throughout the study period. The primary outcome measure will be the numeric rating scale results for itching, whereas the secondary outcome measures will be questionnaire survey (Dermatological Life Quality Index and Epworth Sleepiness Scale) findings and the immune response index, including interferon gamma, interleukin-4, immunoglobulin E, thymic stromal lymphopoietic protein, and histamine, to investigate the biological mechanisms underlying chronic pruritus. DISCUSSION AND CONCLUSIONS: We expect that the results of this study will provide important clinical evidence regarding the effectiveness of Sopoongsan on itching symptoms, quality of life, sleep disturbance, and changes in the immune response. The findings will help elucidate the mechanism underlying the therapeutic effect of Sopoongsan for chronic pruritus and lay the foundation for further studies in this area.

Influence of moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid on facial skin lipidome among seborrhea participants.

BACKGROUND: A better understanding of skin lipidomics and its alteration under treatment administration might offer therapeutic solutions for seborrhea. AIMS: To quantitatively and qualitatively explore the lipid-modifying effect of the moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid (LDCS) in seborrhea participants with and without acne vulgaris (AV). PATIENTS/METHODS: We conducted an open-label explorative study on 20 seborrhea participants (10 AV and 10 non-AV). All participants applied LDCS for 8 weeks with the addition of benzoyl peroxide 2.5% gel and adapalene 0.1%/benzoyl peroxide 2.5% gel in AV. Skin surface lipid (SSL) assessments were performed biweekly, using Sebumeter® and lipid-absorbent Sebutapes® to collect forehead SSL for profile analysis by gas chromatography-mass spectrometry (GC-MS). RESULTS: SSL amount significantly decreased since week 2 in AV (p-value = 0.0124) and week 6 in non-AV (p-value = 0.0098), respectively. Twenty-two important SSLs were annotated from GC-MS analysis, comprising 19 free fatty acids, cholesterol, squalene, and glycerol. There was a significant reduction in 5 and 13 lipid components in AV and non-AV groups, respectively. CONCLUSION: LDCS, either alone or with topical acne treatment, demonstrated substantial sebusuppressive and lipid-modifying effects among seborrhea participants.

Microneedle delivery of botulinum toxin type A combined with hyaluronic acid for the synergetic management of multiple sternal keloids with oily skin: A retrospective clinical investigation.

BACKGROUND: For the treatment of sternal keloids, corticosteroid therapy has side effects including abnormal sebum secretion and acne. Relapse of keloids is common after corticosteroid injection in patients with oily skin. To reduce side effects and keloid recurrence, we used a combination of botulinum toxin type A (BTX-A) and hyaluronic acid (HA) as synergetic management for multiple sternal keloids in patients with oily skin. METHODS: In total, 58 patients with multiple sternal keloids who received monthly steroid injections were retrospectively included. Thirty-two patients in the intervention group received an additional injection of BTX-A/HA on the same day as the first injection of the steroid, while the remaining 26 patients were treated as the control group. At baseline and follow-up visits, sebum production and transepidermal water loss (TEWL) were assessed as primary outcomes, and the Vancouver Scar Scale (VSS) score, keloid recurrence, visual analog scale (VAS) score, and patient satisfaction were assessed as secondary outcomes. RESULTS: In the control group, average sebum production and TEWL were increased to 132% and 104% of baseline, respectively, at the 24-week follow-up. In the intervention group, average sebum production and TEWL reached nadir at the 8-week follow-up and then increased to 96% and 91% of baseline, respectively, at the 24-week follow-up. Sternal keloid relapse was observed in 88.5% of the patients in the control group and none of the patients in the intervention group. The total VSS score at 24 weeks was 11.04 ± 0.14 and 8.93 ± 0.26 (p < 0.001) in the control group and intervention group, respectively, and the VAS score was 75 ± 5.10 and 19.14 ± 3.80 (p < 0.001) in the control group and intervention group, respectively. Higher patient satisfaction was reported in the intervention group. CONCLUSIONS: Microneedle delivery of BTX-A/HA decreases sebum production while improving skin barrier function. Thus, this combined therapy can relieve the side effects of corticosteroid therapy and reduce keloid recurrence.