A newer approach in the treatment of seborrheic dermatitis with QR678® and QR678 Neo®—A prospective pilot study

Background

Seborrheic dermatitis is a common chronic inflammatory skin disorder that affects the scalp and is characterized by erythema and oily scales. It could perhaps be difficult to control and could seriously degrade one's quality of life. The study's objective is to assess the effectiveness of intradermal administrations of QR678 Neo® hair growth factor therapy for the treatment of scalp seborrheic dermatitis in both men and women.

Method

Forty male and female patients with clinically diagnosed seborrheic dermatitis of the scalp in the age 18–45 years, not satisfactorily responding to standard therapy for at least 6 months, were included. 1 mL solution of QR678 Neo® was administered in the scalp skin of all patients at 3-week interval till eight sessions. Patients were advised to continue with antifungal shampoo and topical antifungal solution with steroid combination which they had been on during the treatment. Assessment of disease severity, dermoscopic evaluation, and self-assessment were done at baseline and at the end of the fourth and the eighth sessions.

Results

Improvement was observed in adherent scalp flaking score after eighth session (mean = 12) compared to baseline (mean = 60). The dermoscopic evaluation showed a noticeable difference from baseline (mean = 11) in erythema and scaling with the Seborrheic Dermatitis Scalp Severity Index tool at the end of treatment (mean = 2). A high satisfaction score was given for the efficiency in the self-assessment questionnaire.

Conclusion

Our study proved that treatment with QR678 Neo® led to an improvement in the overall scalp condition by the resolution of flaking and inflammation.     

Pilot study to determine the efficacy of ALA‐PDT photorejuvenation for the treatment of facial ageing

Objective. The study was divided into two parts. The objective of the preliminary study was to evaluate the optimum dose and tolerance of 5‐aminolaevulinic acid (5‐ALA) compared to a placebo cream with a 633‐nm LED light in normal, healthy, volunteer forearm skin. The second study was to establish if ALA‐PDT treatments improve the signs of ageing.

Results. Threshold photosensitization was observed using 5% 5‐ALA under plastic occlusion for 30?minutes following a dose response study of forearm skin. Mild improvement was observed, using this concentration and time, for periorbital skin aging. Other anecdotal positive results of photorejuvenation are reported for facial and chest areas.     

Could azathioprine be considered as a therapeutic alternative in the treatment of alopecia areata? A pilot study

Alopecia areata is an autoimmune disease resulting in partial or total nonscarring hair loss and the treatment of severe alopecia areata is difficult. The aim of this study was to evaluate the efficacy and safety of azathioprine as a systemic monotherapy for moderate to severe alopecia areata. A total of 20 patients [14 men (70%) and six women (30%)] with minimum 6 months history of alopecia areata were included. The extent of scalp hair regrowth during and after the completion of the 6 months treatment was evaluated by the Severity of Alopecia Tool (the SALT score). The daily drug intake was calculated as 2 mg/kg of body weight. Mean duration of current episode of scalp hair loss was 26.4 (26.4 ± 17) months. Mean regrowth percentage was 52.3% (52.3 ± 38.4). Mean hair loss percentage before treatment was 72.7% (72.7 ± 28.3) compared with 33.5% (33.5 ± 30.7) after 6 months of azathioprine treatment. This showed a highly significant statistical difference (Paired t‐test, CI 95% = 21.5–54.1). Mean hair loss score (S₀–S₅) before treatment was 3.9 (3.9 ± 1.6) and after 6 months of azathioprine treatment was 1.8 (1.8 ± 1.3). Assessment showed significant difference from baseline score (sign test, P < 0.0001). No significant statistical difference was observed with respect to gender before and after azathioprine treatment. Treatment with azathioprine as a systemic monotherapy clinically produces relevant improvement in moderate‐to‐severe alopecia areata. Generally azathioprine is a low‐cost and well‐tolerated drug and with controlled studies on larger number of patients, long‐term efficacy and safety of this treatment should be investigated.     

Open-label study of the efficacy and safety of topical treatment with TDT 067 (terbinafine in Transfersome®) in patients with onychomycosis

Background Alopecia areata (AA) is the second most common cause of hair loss in humans, and has a genetically complex inheritance. The hypothesis that AA is autoimmune in nature is supported by previous studies. These report an association with specific HLA alleles, as well as genetic variants of other genes implicated in autoimmunity, such as various cytokine genes. However, these cannot yet be considered proven susceptibility loci, as many of these association findings were derived from small patient samples. Objectives To investigate the association between AA and selected cytokine genes using a sample of 768 patients with AA and 658 controls of Central European origin. Methods Eleven single‐nucleotide polymorphisms (SNPs) from cytokine genes implicated in previous AA studies were genotyped. These genes were IL1B, IL1A, IL1RN, MIF, IFNG and the TNF/LTA gene region. We also genotyped 15 SNPs selected from cytokine genes that have shown significant association with other autoimmune diseases. These genes were IL10, IL36RN, IL12B, IL6, IL2, IL23, IL2RA and IL4R. Results Significant association was found for two variants within both IL2RA and TNF/LTA. In the overall sample, the most significant results were obtained for the IL2RA variant rs706778 (P = 0·00038) and the TNF/LTA locus variant rs1800629 (P = 0·0017). In subgroup analyses, according to severity, age at onset and family history these effects were stronger in the severely affected patients, with the lowest P‐values being obtained for rs706778 (P = 3·8 × 10^?6). Conclusions Our results point to the involvement of IL2RA and the TNF/LTA region in the aetiology of AA, in particular severe AA, and provide further support for the hypothesis that AA is autoimmune in nature.     

Tazarotene versus tazarotene plus hydroquinone in the treatment of photodamaged facial skin: A multicenter,double‐blind,randomized study

Objectives: To compare the efficacy and tolerability of tazarotene plus hydroquinone versus tazarotene alone in the treatment of facial photodamage. Methods: Patients with facial mottled hyperpigmentation of at least moderate severity and an overall integrated assessment of photodamage score of at least moderate applied tazarotene 0.1% cream each evening and either hydroquinone 4% cream or placebo cream each morning for up to 24 weeks. Results: Among 131 patients enrolled, 114/124 (92%) with exit data completed. Both regimens were highly effective in reducing photodamage, with tazarotene plus hydroquinone showing superiority over tazarotene alone for some efficacy measures. The incidence of ?1‐grade improvement from baseline (on a scale of none, minimal, mild, moderate, or severe) was significantly greater with tazarotene plus hydroquinone than with tazarotene alone for lentigines (weeks 12–24, p?0.01) and mottled hyperpigmentation (week 16, p?0.05). The incidence of ?50% global improvement was also significantly superior with the combination regimen as early as week 8 (p?0.01). Both regimens were associated with good tolerability and high patient satisfaction (no significant between‐group differences). Conclusions: The adjunctive use of hydroquinone can enhance the efficacy of tazarotene in reducing dyspigmentation associated with photodamage.     

Experimental study of δ-ALA-PDT in the treatment in BXSB lupus-prone mice

Extracorporeal photochemotherapy can correct immune disease and treat many autoimmune diseases. The aim of this study was to investigate the effects of delta-aminolevulinic acid photodynamic therapy (δ-ALA-PDT) on BXSB mouse. The 24-h urine protein, titers of serum antinuclear antibodies, peripheral blood lymphocyte apoptosis and deposition of immune complex in renal glomeruli were determined in BXSB mice after δ-ALA-PDT treatment. Results showed that δ-ALA-PDT treatment could reduce 24-h urine protein, titers of serum antinuclear antibodies, and deposition of immune complex in renal glomeruli. The δ-ALA-PDT treatment could also lead to significant increase in the rate of peripheral blood lymphocytes.     

Treatment of atrophic facial acne scars with fractional Er:YAG laser in skin phototype III–IV: A pilot study

Background: Fractional ablative lasers have recently been used for the treatment of skin scars. The objective of this study was to assess the efficacy and safety of the fractional erbium-doped yttrium aluminum garnet (Er:YAG) laser (2940 nm) in the treatment of skin scars. Materials and methods: A total of 9 patients (8 female, 1 male) with Fitzpatrick skin types III and IV suffering from atrophic facial acne scars were treated with a fractional Er:YAG laser for 2–5 (mean 3.3) sessions 4–6 weeks apart. One independent investigator assessed the efficacy, using standardized photographs, before and 1 month after the last treatment. The patients’ satisfaction rate was also evaluated. Results: The treatment was well tolerated by all patients without any anesthesia. The downtime was 2–3 days. All patients showed improvement in scars: excellent in 1, good in 1, and fair in 7 patients. Six patients were highly satisfied and 3 were satisfied with treatment. No adverse effect was noted. Conclusion: A fractional Er:YAG laser can deliver an effective and minimally invasive treatment for acne scars.     

Clinical comparison of two hyaluronic acid-derived fillers in the treatment of nasolabial folds: Mesoglow® and IAL System®

Hyaluronic acid (HA) dermal fillers are widely used to reduce the appearance of aging. However, comparative research on the efficacy and safety of products of similar composition is limited. We compared outcomes achieved with two non‐cross‐linked HA fillers of almost identical composition, Mesoglow^® and IAL System^®. Forty subjects with visible nasolabial folds (NLFs) were enrolled in a randomized study. Wrinkle severity was rated using the 5‐point Wrinkle Severity Rating Scale (WSRS). Each subject was injected with Mesoglow^® in one NLF and IAL System^® in the other. An optimal cosmetic result was established at two weeks after a second treatment. Participants were then reassessed at 2, 6, and 12 weeks, respectively, post‐optimal cosmetic result using the WSRS. The degree of improvement was also assessed by subjects and investigators using the Global Aesthetic Improvement Scale (GAIS). At baseline, the mean WSRS score was 3.20 ± 0.41. At the optimal cosmetic result, 98% of subjects showed a 1‐ or 2‐point change in WSRS score with either treatment. All subsequent WSRS scores were significantly improved over baseline for both treatments. There was no significant difference between treatments or improvement in WSRS score at any point in time. Investigator GAIS scores at weeks 4 and 6 were slightly but not significantly higher for Mesoglow^®‐treated skin. There was no significant difference in the frequency of local adverse responses. No serious systemic adverse events occurred. This study indicates that Mesoglow^® and IAL System^® are equally effective in achieving short‐term correction of NLFs, but the longevity of their effects is limited.     

Do we alter ultraviolet sensitivity in vivo with stratum corneum rehydration? A pilot study and review of the literature

BACKGROUND: Numerous therapeutic schemes recommend topical administration of emollients immediately prior to ultraviolet (UV) B therapy. The rationale behind the clinical improvement is a presumed enhancement of UV transmission through the epidermis. Originating from this clinical observation, there has been some concern as to whether a well-hydrated skin in general might be more susceptible to actinic damage. OBJECTIVES: To investigate whether rehydration of healthy skin causes an altered UVB sensitivity in vivo. METHODS: We determined minimal erythema doses (MEDs) and erythema sum scores (ESSs) after differential rehydration of the skin in 10 healthy volunteers. In each subject six UVB phototests were performed after pretreatment with five different emulsifying ointments (unguentum emulsificans and dilutions with 30, 50, 70 and 90% aqua purificans) plus a negative control. In vivo evaluation of stratum corneum hydration was performed by measurement of electrical capacitance. RESULTS: The results of this randomized, double-blind in vivo study indicated that rehydration of normal stratum corneum with the emulsifying ointments tested did not result in a significantly altered sensitivity to the erythematous effects of UVB irradiation (no significant differences in MED and ESS). Furthermore, there was no correlation between measured stratum corneum hydration and the erythema response of healthy skin. CONCLUSIONS: Although many schemes recommend the administration of emollients prior to UV therapy, there have also been calls for caution, as an uncritical application may interfere with such treatment. We showed that the emulsifying ointments tested exhibited no photoprotective potential and thus are suitable for the pretreatment of psoriasis prior to phototherapy. It has long been discussed whether the effects of emollient pretreatment on response to UV occur only in psoriatic skin or also in healthy skin. Our results indicated that stratum corneum rehydration did not result in a significantly increased erythema response of healthy skin to UVB exposure. With regard to the use of rehydrating cosmetics in everyday life, the outcome of our pilot study is reassuring, as we could not confirm with our experimental design that well-hydrated healthy skin is more prone to actinic damage.     

Effects of Hydroxydecine(®) (10-hydroxy-2-decenoic acid) on skin barrier structure and function in vitro and clinical efficacy in the treatment of UV-induced xerosis

10-Hydroxy-2-decenoic acid, a natural fatty acid only found in royal jelly, may be of value in correcting skin barrier dysfunction. We evaluated the activity of Hydroxydecine(?), its synthetic counterpart, in vitro on the regulation of epidermal differentiation markers, ex vivo on the inflammatory response and restoration of skin barrier function, and in vivo on UV-induced xerosis in healthy human volunteers. In cultured normal human keratinocytes, Hydroxydecine(?) induced involucrin, transglutaminase-1 and filaggrin protein production. In topically Hydroxydecine(?)-treated skin equivalents, immunohistochemical analysis revealed an increase in involucrin, transglutaminase-1 and filaggrin staining. In a model of thymic stromal lymphopoietin (TSLP)-induced inflamed epidermis, a Hydroxydecine(?)-containing emulsion inhibited TSLP release. In a model of inflammation and barrier impairment involving human skin explants maintained alive, Hydroxydecine(?) balm restored stratum corneum cohesion and significantly increased filaggrin expression, as shown by immunohistochemistry. It also decreased pro-inflammatory cytokine secretion (IL-4, IL-5 and IL-13). In healthy volunteers with UV-induced xerosis, the hydration index increased by +28.8% (p<0.01) and +60.4% (p<0.001) after 7 and 21 days of treatment with Hydroxydecine(?) cream, respectively. Hydroxydecine(?) thus proved its efficacy in activating keratinocyte differentiation processes in vitro, restoring skin barrier function and reducing inflammation ex vivo, and hydrating dry skin in vivo.     

Is metronidazole 0.75% gel effective in the treatment of seborrhoeic dermatitis? A double-blind, placebo controlled study

The study aimed to evaluate the effectiveness of metronidazole 0.75% gel in patients with mild and moderate seborrhoeic dermatitis. Sixty-seven patients with seborrhoeic dermatitis were enrolled. Cases were randomly treated with metronidazole 0.75% gel or placebo for four weeks and were additionally followed up for another four weeks. Patients were evaluated by scoring before the treatment, once a week during the treatment and twice after the cessation of the treatment within a 15-day interval. Furthermore, patient satisfaction and doctor global evaluation were done at the end of the treatment and of the study as well. In the metronidazole group 33 patients (median age: 26, total severity score: 15.0 +/- 11.0 (median +/- interquartile range) and in the placebo group 34 patients (median age: 26, total severity score: 13.0 +/- 7.5) were enrolled in the study. Three patients from the metronidazole group and four patients from the placebo group did not attend to follow-up visits. Erythema, scales, papule, pruritus and the total severity scores in both group decreased significantly during the treatment when compared with the basal levels (p < 0.05). There was no difference between the two groups in terms of efficacy (p > 0.05). Total severity scores were found as 7.33 +/- 1.08 and 6.43 +/- 0.93 in the metronidazole and placebo groups at the end of the treatment, respectively. After the cessation of the treatment, all scores had increased rapidly. Total severity scores were 10.40 +/- 1.54 and 11.20 +/- 1.53 in the metronidazole and placebo groups one month after the cessation of the treatment, respectively. Both metronidazole 0.75% gel and the placebo were well tolerated by the patients. In conclusion, in the treatment of seborrhoeic dermatitis, administration of metronidazole 0.75% gel is well tolerated but it is only as effective as placebo and the disease severity quickly returns to the basal levels after the cessation of treatment.     

A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice

Abstract:  One hundred seventy-two subjects with head lice participated in a five-way, investigator-blinded, parallel-group, active-controlled study comparing 0.5% malathion gel (30, 60, and 90 minutes applications), Ovide^® Lotion (0.5% malathion), and Nix^® Crème Rinse (1% permethrin). All subjects were treated on day 1. Participants were reevaluated at day 8 ± 1 and those with live lice were retreated with the same product, for the same duration as day 1. Cure, defined as the absence of live lice, was evaluated 14 ± 2 days after the last treatment and 161 subjects completed the study according to the protocol. Compared to Nix, treatment success rates were statistically superior for all malathion gel and Ovide^® groups. Retreatment rate for Nix was 70%, which was statistically more than the malathion groups. The highest treatment success rates were observed for the 30-minute malathion gel (98% intent-to-treat and 100% per-protocol [PP]) and the 8 to 12 hour Ovide^® application (97% intent-to-treat and 100% PP). In conclusion, the 30-minute malathion gel, which contains the same ingredients and concentrations as Ovide^®, provides comparable efficacy, offers increased safety and is more cosmetically acceptable than Ovide^®.     

A split‐face comparison of a new hyaluronic acid facial filler containing pre‐incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso‐labial folds

This split‐face, single‐blind study compared the comfort and ease of injection of a new hyaluronic acid facial filler containing pre‐incorporated lidocaine (Juvéderm^® ULTRA 3) versus the established hyaluronic acid facial filler Restylane‐Perlane^®. A total of 126 individuals were treated with both products, randomly assigned to the right or left naso‐labial fold. Injector assessment‐indicated mean injection pain, pain of massaging the injected area and post‐injection discomfort (based on a scale of 0=no pain to 10=extreme pain) were 2.1, 0.9 and 0.4 for Juvéderm ULTRA 3, and 4.1, 3.3 and 1.7 for Restylane‐Perlane, respectively (p<0.0001). Patient assessment of the same parameters were 2.8, 1.3 and 0.4 for Juvéderm ULTRA 3, and 4.9, 3.6 and 1.8 for Restylane‐Perlane (p<0.0001). Injectors indicated that 92% of Juvéderm ULTRA 3 injections were ‘very easy’, compared with 21% for Restylane‐Perlane. Post‐treatment smoothness was comparable, but 95% of individuals preferred Juvéderm ULTRA 3 for overall injection comfort. A total of 95% of individuals indicated that Juvéderm ULTRA 3 was a more comfortable and gentle experience.     

Pain inhibition in Q‐switched laser tattoo removal with pneumatic skin flattening (PSF): A pilot study

Background: Tattoo removal with a Q‐switched laser is often a painful procedure. The sensation of pain associated with the treatment is immediate and acute. Application of topical anesthesia to the treated area of the skin is time‐consuming, with only very moderate pain relief. Objective: To determine the efficacy of pneumatic skin‐flattening (PSF) technology which utilizes an evacuation chamber that generates skin compression and activates tactile neural receptors in the skin, resulting in afferent inhibition of pain transmission in the dorsal horn (the ‘gate theory’). Methods: Eleven young patients aged 17–25 years old (nine females, two males) who were treated for tattoo removal were enrolled in the study. The patients were treated by a Q‐switched Nd:YAG laser. Acute pain evaluation was performed on all 11 patients: one to two sites per patient with PSF and one to two control sites without PSF. When patients were treated with PSF, they knew they were being treated with a device that might reduce pain. This may have influenced patients' perception of pain. The evaluation was based on a modified McGill pain questionnaire. Results: All 11 patients completed the study. A lower pain score with PSF was observed in all but one patient (10/11 or 91%). The average reduction of pain is by two levels: from very painful to very mild pain. The energy transmission of the PSF window is 95%, resulting in essentially identical efficacy of the PSF treatment and the regular non‐PSF treatment. Conclusion: This pilot study indicates that PSF technology may reduce pain in tattoo removal with medium energy density Q‐switched lasers (3–5?J/cm²).     

A retrospective study on laser treatment of nevus of Ota in Chinese children—a seven-year follow-up

Abstract

Objective: To retrospectively study laser treatment of nevus of Ota in children. Methods: Clinically analyzing characteristics, effects, side effects, and recurrence of a 104 cases of nevus of Ota in children under 12 years, including 32 boys and 72 girls. Results: After seven treatments, cure rate of lesion color fading and area reducing were 79.81% and 75.96%, respectively. After 10 treatments, both of the two cure rates were 96.15%. Later the cure rate was constant with even more treatments. The younger the first treating age, the lesser the treatments are. The younger the age of onset, the higher the relapse after clearance. Conclusion: Nevus of Ota should be treated as early as possible to reach better efficacy with less treatments. The younger the onset age, the easier it recurs.     

Does it look like melanoma? A pilot study of the effect of sunless tanning on dermoscopy of pigmented skin lesions

Background Dermoscopy has led to an improvement in diagnosing malignant melanoma (MM). Sunless tanning agents containing dihydroxyacetone (DHA) could lead to a decrease in ultraviolet exposure, decreasing the risk of MM. Importantly, DHA has been reported to change dermoscopic features and could thus endanger diagnostic improvement in dermoscopy. Objectives To investigate whether the use of DHA can lead to changes that simulate a real, clinically relevant dermoscopic change, suggesting malignant transformation either in facial solar lentigo/initial seborrhoeic keratosis (SL/ISK) or in naevi on the body. Methods Seven patients with 25 pigmented skin lesions (PSLs) were photographed, resulting in 38 dermoscopic images. Photographs were taken before, 1 week after and 1–2 months after the use of DHA. Two dermatologists separately evaluated the PSLs and their dermoscopic features. For lesions on the body Menzies’ method was used, and for facial lesions the criteria defined by Stolz et al. were used. Results In facial PSLs equivocal lesions were registered by both evaluators significantly more often after DHA use than before (42% vs. 12%, P = 0·021 and 69% vs. 19%, P = 0·001). Furthermore, follicular pigmentation that partly mimics that of lentigo maligna was also seen significantly more often after DHA use than before (81% vs. 12%, P < 0·001 and 69% vs. 15%, P < 0·001) and in these instances the evaluators recommended a biopsy. Equivocal lesions in naevi on the body were not significantly increased after DHA use. Conclusions Dermoscopists that come across unclear dermoscopic findings, especially in facial PSL, should ask patients about the use of DHA.     

Failure of omalizumab (Xolair®) in the treatment of a case of solar urticaria caused by ultraviolet A and visible light

Solar urticaria is a rare photodermatosis probably caused by a chromophore, that – if activated by light of a specific spectrum – binds to mast cell‐bound IgE and elicits degranulation. In our patient an action spectrum in ultraviolet A and visible light range was found, in the autologous serum test the presence of a serum chromophore for the same action spectra could be demonstrated, which may underline this pathogenetic hypothesis. Symptoms did not improve using antihistamines and sun protection. Photo hardening was denied from the patient, immunosuppression and plasmapheresis were discussed but not considered. So a treatment with Omalizumab was started that recently was successfully used in 4 case reports. After 3 doses of Xolair® there was no changing in the phototesting results and after 4 doses no subjective improvement.