Resolving acne with optimized adapalene microspongeal gel, in vivo and clinical evaluations.

In our pursuit of enhancing acne treatment while minimizing side effects, we developed tailored Adapalene microsponges (MS) optimized using a Box-Behnken design 33. The independent variables, Eudragit RS100 percentage in the polymer mixture, organic phase volume, and drug to polymer percentage, were explored. The optimized formulation exhibited remarkable characteristics, with a 98.3% ± 1.6 production yield, 97.3% ± 1.64 entrapment efficiency, and a particle size of 31.8 ± 1.1 µm. Notably, it achieved a 24 h cumulative drug release of 75.1% ± 1.4. To delve deeper into its efficacy, we evaluated the optimized microspongeal-gel in vitro, in vivo, and clinically. It demonstrated impressive retention in the pilosebaceous unit, a target for acne treatment. Comparative studies between our optimized Adapalene microspongeal gel and marketed Adapalene revealed superior performance. In vivo studies on Propionibacterium acnes-infected mice ears showed a remarkable 97% reduction in ear thickness, accompanied by a significant decrease in inflammatory signs and NF-κB levels, as confirmed by histopathological and histochemical examination. Moreover, in preliminary clinical evaluation, it demonstrated outstanding effectiveness in reducing comedonal lesions while causing fewer irritations. This not only indicates its potential for clinical application but also underscores its ability to enhance patient satisfaction, paving the way for future commercialization.

Unraveling the pharmaceutical and clinical relevance of the influence of syringic acid loaded linoleic acid transferosomes on acne.

Natural medicines are promising platforms for competent topical treatment modalities benefiting the cosmetic implementation and proffering solutions to the current remedies. Therefore, the objective of this study was to formulate syringic acid (SA), well-known for its multilateral anti-inflammatory, antimicrobial and antioxidant potentials, in newly developed linoleic acid (LA) transferosomes as an anti-acne nano-form remedy. Herein, LA was incorporated in transferosomes owing to its antimicrobial effect and dermal penetrability. Comprehensive appraisal through physicochemical, antioxidant and dermal deposition investigations was conducted. Clinical assessment was also performed in acne patients and compared with the marketed product (Adapalene® gel). The relevant investigations of the optimum formula indicated stable vesicles with a small-sized diameter (147.46 nm), surface charge (-26.86 mV), spherical architecture, reasonable entrapment (76.63%), considerable antioxidant activity (IC50 = 11.1 µg/mL) and remarkable skin deposition (78.72%).More importantly, LA based transferosomes enclosing SA exhibited inflammation lessening in acne sufferers as manifested by greater reduction in the total count of the acne lesions reaching 79.5% in contrast to Adapalene® gel with only 18.7% reduction in acne lesions. Interestingly, no irritation and erythema were reported for the proposed transferosomes. Inclusively, the cosmetic formulation practice could reap benefits of the development of such vesicles.

Exploring the Synergistic Effect of Bergamot Essential Oil with Spironolactone Loaded Nano-Phytosomes for Treatment of Acne Vulgaris: In Vitro Optimization, In Silico Studies, and Clinical Evaluation.

The foremost target of the current work was to formulate and optimize a novel bergamot essential oil (BEO) loaded nano-phytosomes (NPs) and then combine it with spironolactone (SP) in order to clinically compare the efficiency of both formulations against acne vulgaris. The BEO-loaded NPs formulations were fabricated by the thin-film hydration and optimized by 32 factorial design. NPs' assessments were conducted by measuring entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP). In addition, the selected BEO-NPs formulation was further combined with SP and then examined for morphology employing transmission electron microscopy and three months storage stability. Both BEO-loaded NPs selected formula and its combination with SP (BEO-NPs-SP) were investigated clinically for their effect against acne vulgaris after an appropriate in silico study. The optimum BEO-NPs-SP showed PS of 300.40 ± 22.56 nm, PDI of 0.571 ± 0.16, EE% of 87.89 ± 4.14%, and an acceptable ZP value of -29.7 ± 1.54 mV. Molecular modeling simulations showed the beneficial role of BEO constituents as supportive/connecting platforms for favored anchoring of SP on the Phosphatidylcholine (PC) interface. Clinical studies revealed significant improvement in the therapeutic response of BEO-loaded NPs that were combined with SP over BEO-NPs alone. In conclusion, the results proved the ability to utilize NPs as a successful nanovesicle for topical BEO delivery as well as the superior synergistic effect when combined with SP in combating acne vulgaris.

Q-switched Nd:YAG laser versus itraconazole pulse therapy in treatment of onychomycosis: A clinical dermoscopic and mycologic study.

BACKGROUND: Onychomycosis (OM) represents about 50% of nail disorders. Oral antifungals have proven efficacy in the treatment of onychomycosis but their associated side effects limit their use. Accordingly, there is an increased need for a safe and effective therapy to induce clearance and improve the esthetic appearance of diseased nails. OBJECTIVE: The current study is an attempt to evaluate and compare the efficacy of Q-Switched Nd:YAG (1064 nm) laser as monotherapy versus pulse itraconazole in the clearance of onychomycosis. METHODS: In this prospective study, 40 onychomycosis patients were equally divided into two groups: Groups I (laser group) and II (Itraconazole group). Patients of Group I are treated with six biweekly sessions of Q-Switched Nd:YAG (1064 nm) laser. Patients of Group II are treated with itraconazole pulse therapy. The assessment of clearance was rated using the "Onychomycosis Severity Index (OSI)", photographs, dermoscopy, and mycology. All 40 patients were followed up for 3 months after the end of treatment. RESULTS: Group I's clinical improvement response was a marked improvement in 19 cases and moderate improvement in one case (OSI before treatment was 24.5 and after was 0). A dermoscopic cure occurred in 19 cases. Mycological cure was obtained in 19 cases. Group II's clinical improvement response was marked in 15 and moderate in 5 (OSI before treatment was 24 and after was 0). Dermoscopic cure occurred in 15 cases. Mycological cure was obtained in 15 cases. There were no adverse effects. The clinical response, the dermoscopic cure, and the mycological cure were equal in both groups, with no significant difference found between them. CONCLUSION: Q-Switched Nd:YAG (1064 nm) laser can be used as an effective and safe modality in the clearance of nail onychomycosis, particularly in patients who have a contraindication to or refuse the use of oral antifungals.

Assessment of antifungal efficacy of itraconazole loaded aspasomal cream: comparative clinical study.

Topical conveyance of antifungal agents like itraconazole ITZ has been giving good grounds for expecting felicitous antifungal medicines. The defiance of topical delivery of this poorly water soluble and high-molecular-weight drug, however, mightily entail an adequate vehiculation. ITZ aspasomes, newer antioxidant generation of liposomes, have been designed and enclosed in a cream to ameliorate skin deposition. The proposed creams containing non-formulated ITZ or encapsulated in aspasomes (0.1% or 0.5%) were topically applied in patients with diagnosed diaper dermatitis complicated by candidiasis, tinea corporis (TC), and tinea versicolor (TVC). Placebos (void aspasomal cream and cream base) were also utilized. The obtained results for diaper rash revealed that aspasomal cream (0.5% ITZ) was eminent with respect to complete cure and negative candida culture after 10-day therapy relative to counterparts containing 0.1% ITZ aspasomes or non-formulated ITZ (0.1% and 0.5%). For tinea, the same trend was manifested in terms of 'cleared' clinical response in 90% of patients and absence of fungal elements after 4-week treatment. Relative to non-formulated ITZ, ITZ aspasomal cream was endorsed to be auspicious especially when ITZ concentration was lowered to half commercially available cream concentration (1%), pushing further exploitation in other dermal fungal infections.

Fenticonazole nitrate loaded trans-novasomes for effective management of tinea corporis: design characterization, in silico study, and exploratory clinical appraisal.

The current investigation aimed for loading fenticonazole nitrate (FTN), an antifungal agent with low aqueous solubility, into trans-novasomes (TNs) for management of tinea corporis topically. TNs contain Brij® as an edge activator besides the components of novasomes (cholesterol, Span 60, and oleic acid) owing to augment the topical delivery of FTN. TNs were fabricated applying ethanol injection method based on D-optimal experiment. TNs were evaluated with regard to entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP). Further explorations were conducted on the optimum formulation (F7). F7 showed spherical appearance with EE%, PS, PDI, and ZP of 100.00 ± 1.10%, 358.60 ± 10.76 nm, 0.51 ± 0.004, and -30.00 ± 0.80 mV, respectively. The in silico study revealed the ability of the FTN-cholesterol complex to maintain favorable interactions throughout the molecular dynamics simulation (MDS) study. Moreover, Trichophyton mentagrophytes growth was inhibited effectively by F7 than by FTN suspension applying 2,3-bis(2-methyloxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide (XTT) reduction assay. Furthermore, a clinical appraisal on patients with tinea corporis fungal lesions confirmed the superiority of F7 compared to Miconaz® cream in the magnitude of clinical cure of tinea corporis. Thereby, TNs could be considered as promising vesicles for enhancing the antifungal potential of FTN for the topical management of tinea corporis.

Pityriasis alba: toward an effective treatment.

BACKGROUND: Pityriasis alba is a common skin condition that may be challenging to treat, especially in patients with darker skin type where the hypopigmentation may be more noticeable and represents a major cosmetic concern. OBJECTIVES: This study aims to evaluate the efficacy of three cost-effective treatments of PA in comparison with placebo. PATIENTS/METHODS: This prospective study was conducted on 80 patients complaining from PA and divided into 4 equal groups according the received topical treatment on the target lesions twice daily for 8 weeks (Calcipotriol 0.005% cream, Tacrolimus 0.03% ointment, topical corticosteroid; Clobetasone butyrate 0.05% cream and Petrolatum as Placebo). Clinical evaluation, Physician Global Assessment, Patient's satisfaction levels as well as point counting planimetry were done for evaluation of the response. RESULTS: Significant improvement of scaling and erythema within 3 weeks after initiation of therapy and hypopigmentation by the 8th week, except for those received placebo. Tarolimus 0.03% ointment showed simple superiority over both Calcipotriol 0.005% cream and topical corticosteroid as regards repigmenation, although, the later received the highest level of patient satisfaction. CONCLUSION: The three treatments were superior to placebo with relative superiority to Tacrolimus 0.03% due to limited side effects.

Clinical, dermoscopic, and histopathologic evaluation of vitamin C versus PRP, with microneedling in the treatment of mixed melasma: A split-face, comparative study.

Melasma is a common esthetic problem affecting the face with a lot of risk factors being incriminated. Although several treatment options are available, none of them is satisfactory. This split face prospective study aimed to compare the efficacy of microneedling with vitamin C versus with platelet-rich plasma (PRP) in the management of mixed melasma. Ten females with bilateral mixed facial melasma were treated with six sessions of microneedling. After the needling vitamin C was applied on the right side of the face and PRP was applied on the left side. Clinical, dermoscopic, and histological assessment of the used treatments was done 1 month after the last session. The clinical and dermoscopic clearance of melasma was proved significantly on both sides of the face but was more significant with vitamin C (P = 0.005). Reduction of epidermal melanin and dermal melanophages was more observed with vitamin C. Moreover, MART-1 stain revealed a more significant reduction in the epidermal, dermal, and the total MART-1 positive cells with vitamin C (P = 0.044, 0.039, and 0.035, respectively). Microneedling with vitamin C was more efficient in treating mixed melasma than with PRP.

Use of Novasomes as a Vesicular Carrier for Improving the Topical Delivery of Terconazole: In Vitro Characterization, In Vivo Assessment and Exploratory Clinical Experimentation.

PURPOSE: This manuscript aimed at encapsulating an antifungal terconazole (TCZ) into innovative novasomes for improving its penetration into the skin and clinically modulating its therapeutic efficacy. METHODS: Novasomes containing free fatty acid (FFA) as a penetration enhancer were formulated using ethanol injection technique based on 24 full factorial design to explore the impact of various formulation variables on novasomes characteristics regarding entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP). The optimum formulation was chosen using Design-Expert® software and utilized for further explorations. RESULTS: The chosen formulation (N15; including 100 mg lipid components and Span 80 to oleic acid in a ratio of 2:1 (w/w)) exhibited an EE% = 99.45 ± 0.78%, PS = 623.00 ± 2.97 nm, PDI = 0.40 ± 0.04, and ZP = -73.85 ± 0.64 mV. N15 showed spherical vesicles with a higher deformability index (DI) (9.62 ± 0.15 g) compared to traditional niosomal formulation (0.92 ± 0.12 g). Further, N15 showed superior inhibition of Candida albicans growth relative to TCZ suspension using XTT (2,3-bis-(2-methyloxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide) reduction assay. Moreover, in vivo skin deposition tests revealed a superior TCZ deposition inside the skin from N15 in comparison to traditional niosomal formulation and TCZ suspension. Furthermore, histopathological examination for rats assured the safety of N15 for topical use. A clinical study conducted on infants suffering from napkin candidiasis proved the superiority of N15 to placebo in providing a complete cure of such fungal infections. CONCLUSION: Concisely, the obtained outcomes confirmed the pronounced efficacy of N15 to successfully treat skin fungal infections.

Facial rejuvenation using stem cell conditioned media combined with skin needling: A split-face comparative study.

BACKGROUND: The use of stem cells derived growth factors is representing a novel treatment modality in facial rejuvenation. Nowadays, skin needling is considered a very famous treatment of skin aging. However, the addition of such derived products, augments its therapeutic efficacy in the management and delay of skin aging. OBJECTIVE: Comparing the effect of amniotic fluid mesenchymal stem cell derived conditioned media (AF-MSC-CM) combined with skin needling versus the needling alone in the management of facial aging. METHODS: Both sides of the face of ten volunteers, suffering from facial aging, were treated with five sessions of skin needling, 2 weeks apart. After skin microneedling, AF-MSC-CM was added topically to the right side only. Clinical, histological, and morphometrical assessment of the treated skin was done at 1 month after the last session. RESULTS: The percentage of improvement of aged skin increased significantly on the combined treated side (AF-MSC-CM and dermaroller [DR]), when compared with the other side (DR only) (P < .001). Remodeling of the dermal structures was observed mainly on the combined side. Meanwhile, histometry of the epidermis revealed a significant increase in the epidermal thickness on both treated sides. CONCLUSION: AF-MSC-CM combined with skin needling was more efficient in managing facial aging than skin needling alone.

Amniotic fluid-derived mesenchymal stem cell products combined with microneedling for acne scars: A split-face clinical, histological, and histometric study.

BACKGROUND: Postacne scars are still a challenge in its management. Microneedling is a popular minimally invasive technique in treatment of such scars. However, the addition of topical stem cell products after microneedling is considered a new treatment regimen for these scars. OBJECTIVE: To compare efficacy of amniotic fluid-derived mesenchymal stem cell-conditioned media (AF-MSC-CM) and microneedling vs microneedling alone in management of atrophic acne scars. METHODS: Ten cases with atrophic postacne scars received five sessions of microneedling, with 2-week interval on both sides of the face. Then, AF-MSC-CM was topically applied to right side of the face after microneedling. Clinical examination with histopathological and computerized histometric analysis was done 1 month after the sessions. RESULTS: There was significant increase in the improvement percentage of acne scars on right side (dermaroller and AF-MSC-CM) vs left side of face (dermaroller; P < 0.001). Histologically, improvement of character of collagen and elastic fibers was noticed, especially on right side. Meanwhile, significant increase in epidermal thickness on both sides of face was detected. CONCLUSION: Amniotic fluid-derived mesenchymal stem cell-conditioned media combined with microneedling is more effective in management of atrophic postacne scars than microneedling alone.