Thiamidol® in moderate-to-severe melasma: 24-week, randomized, double-blind, vehicle-controlled clinical study with subsequent regression phase.

Thiamidol® was the most potent inhibitor of human tyrosinase out of 50 000 screened substances. In vivo, it was well tolerated and improved melasma significantly. This was the first 24-week, randomized, double-blind, vehicle-controlled, cosmetic clinical study to assess the efficacy and tolerability of thiamidol in moderate-to-severe melasma of phototype III-V subjects with subsequent regression phase. Females allocated to verum (n = 23), applied daily Dual Serum followed either by Day Care SPF30 in the morning or by Night Care in the evening, all containing Thiamidol. The vehicle group (25 females) followed the same skin care routine using the corresponding vehicle formulations. Subjects came back for a follow-up visit 13-20 weeks after treatment (regression phase). Assessments included clinical photography, Melasma Area and Severity Index (MASI), skin lightness, quality of life, and tolerability. Baseline demographics and hyperpigmentation were well balanced across the treatment groups. Clinical photography and MASI improved with Thiamidol significantly versus baseline (p < 0.001) and vehicle (p < 0.001-0.043) at all time points up to treatment end. At follow-up, the MASI was still significantly lower than at baseline but similar for verum and vehicle. Skin lightness and quality of life improved significantly versus baseline without significant differences between verum and vehicle. This study demonstrated that Thiamidol is well tolerated and superior in improving melasma compared to baseline and vehicle over a treatment period of 24 weeks.

Effective reduction of post-inflammatory hyperpigmentation with the tyrosinase inhibitor isobutylamido-thiazolyl-resorcinol (Thiamidol).

OBJECTIVE: Post-inflammatory hyperpigmentation (PIH) is a major cosmetic concern especially in individuals with darker skin complexion. Unfortunately, treatment with anti-inflammatory ingredients alone does not prevent the development of hyperpigmented spots. Recently, isobutylamido-thiazolyl-resorcinol (Thiamidol) was described as a very potent inhibitor of human tyrosinase. The objective of this research was to investigate the potential of this compound to prevent PIH induced by epidermal wounding (suction blister) and related to acne. METHODS: Suction blister-induced PIH was treated with a formulation containing Thiamidol or a vehicle for 3 months, and the changes in hyperpigmentation were monitored by spectroscopic measurements. The effect of skin care formulations containing Thiamidol on acne-related PIH was investigated in two studies, a vehicle-controlled, double-blinded, randomized clinical study and a clinical observational study. Both studies had a duration of 3 months and included assessments such as clinical photography, clinical grading and melanin index measurements. RESULTS: Already after 2 weeks of treatment, suction blister sites treated with Thiamidol were significantly lighter than control sites and improved throughout the treatment period. Subjects´ self-grading demonstrated that Thiamidol significantly improved the visibility of acne-induced hyperpigmentation compared to the vehicle treatment. A skin care regimen with Thiamidol significantly improved acne-related PIH over 12 weeks shown by Mexameter measurements, expert grading, self-grading and clinical photography. CONCLUSION: Thiamidol represents a safe and effective ingredient for cosmetic products against post-inflammatory hyperpigmentation.

OBJECTIF: L'hyperpigmentation post-inflammatoire (Post-Inflammatory Hyperpigmentation, PIH) est une préoccupation d'ordre esthétique majeure, en particulier chez les personnes dont le teint est plus foncé. Malheureusement, un traitement par des ingrédients anti-inflammatoires seuls n'empêche pas le développement de taches hyperpigmentées. Récemment, l'isobutylamido-thiazolyl-résorcinol (Thiamidol) a été décrit comme un inhibiteur très puissant de la tyrosinase humaine. L'objectif de cette investigation était d'étudier le potentiel de ce composé pour prévenir la PIH induite par une plaie épidermique (bulle de succion) et liée à l'acné. MÉTHODES: La PIH induite par la bulle de succion a été traitée avec une formulation contenant du Thiamidol ou un véhicule pendant 3 mois et les changements dans l'hyperpigmentation ont été surveillés par le biais de mesures spectroscopiques. L'effet des formulations pour soins de la peau contenant du Thiamidol visant à traiter la PIH liée à l'acné a été étudié au cours de deux études : une étude clinique randomisée, en double aveugle, contrôlée par véhicule et une étude clinique observationnelle. Les deux études avaient une durée de 3 mois et comportaient des évaluations telles que la photographie médicale, l'évaluation par les médecins et les mesures de l'indice de mélanine. RÉSULTATS: Après 2 semaines de traitement seulement, les sites de bulles de succion traités par du Thiamidol étaient significativement plus clairs que les sites-témoins et avaient montré une amélioration tout au long de la période de traitement. L'auto-évaluation des sujets a démontré que le Thiamidol améliorait significativement la visibilité de l'hyperpigmentation induite par l'acné par rapport au traitement par véhicule. Un programme de soins de la peau contenant du Thiamidol a significativement amélioré la PIH liée à l'acné sur 12 semaines, comme l'ont démontré les mesures de Mexameter, l'évaluation par des experts, l'auto-évaluation des sujets et la photographie médicale. CONCLUSION: Le Thiamidol représente un ingrédient sûr et efficace pour les produits cosmétiques contre l'hyperpigmentation post-inflammatoire.

Recurrent stroke: the role of thrombophilia in a large international pediatric stroke population.

Risk factors for arterial ischemic stroke in children include vasculopathy and prothrombotic risk factors but their relative importance to recurrent stroke is uncertain. Data on recurrent stroke from databases held in Canada (Toronto), Germany (Kiel-Lübeck/Münster), and the UK (London/Southampton) were pooled. Data were available from 894 patients aged 1 month to 18 years at first stroke (median age, 6 years) with a median follow-up of 35 months. Among these 894 patients, 160 (17.9%) had a recurrence between 1 day and 136 months after the first stroke (median, 3.1 months). Among 288 children with vasculopathy, recurrence was significantly more common [hazard ratio (HR) 2.5, 95% confidence interval (95% CI) 1.92-3.5] compared to the rate in children without vasculopathy. Adjusting for vasculopathy, isolated antithrombin deficiency (HR 3.9; 95% CI: 1.4-10.9), isolated elevated lipoprotein (a) (HR 2.3; 95% CI: 1.3-4.1), and the presence of more than one prothrombotic risk factor (HR 1.9; 95% CI: 1.12-3.2) were independently associated with an increased risk of recurrence. Recurrence rates calculated per 100 person-years were 10 (95% CI: 3-24) for antithrombin deficiency, 6 (95% CI: 4-9) for elevated lipoprotein (a), and 13 (95% CI: 7-20) for the presence of more than one prothrombotic risk factor. Identifying children at increased risk of a second stroke is important in order to intensify measures aimed at preventing such recurrences.

Treatment of xerosis with a topical formulation containing glyceryl glucoside, natural moisturizing factors, and ceramide.

OBJECTIVE: To assess the effects of Light Formulation, an oil-in-water emulsion, and Rich Formulation, a water-in-oil emulsion, for the treatment of xerosis. DESIGN: Two double-blind, vehicle-controlled trials (both formulations); a double-blind, randomized regression study (Rich Formulation); and a single-blind tolerability study (Light Formulation). The two formulations were applied twice daily for two weeks, for five days in the regression study, and twice daily for two weeks in the tolerability study. SETTING: Studies were conducted during winter in Hamburg, Germany. PARTICIPANTS: A total of 169 subjects were enrolled and 154 completed the studies. The majority were between 50 and 80 years of age, women, all with very dry skin. One withdrew because of an incompatibility reaction that reoccurred with the subject's own body lotion after sun exposure. MEASUREMENTS: Skin hydration and skin barrier function with both formulations over two weeks, long-term moisturization effect after discontinuation of Rich Formulation, and symptom improvement and skin tolerability with Light Formulation. RESULTS: Vehicle-controlled studies of Light and Rich Formulations demonstrated significantly improved hydration at Weeks 1 and 2 versus the untreated site and vehicles, and significantly reduced transepidermal water loss versus untreated site and basic vehicle. Both products significantly decreased visible dryness and tactile roughness. In the regression study, Rich Formulation maintained significant moisturization six days after treatment discontinuation. Light Formulation reduced symptoms of itching, burning, tightness, tingling, and feeling of dryness. CONCLUSION: These formulations represent a new approach for the treatment of xerosis by addressing multiple key deficiencies in skin hydration.

Natural Arctium lappa fruit extract improves the clinical signs of aging skin.

BACKGROUND: Subclinical, chronic tissue inflammation involving the generation of cytokines (e.g., interleukin-6 and tumor necrosis factor-alpha) might contribute to the cutaneous aging process. AIMS: This study aims to screen for an active ingredient with anti-inflammatory (i.e., reduction of interleukin-6 and tumor necrosis factor-alpha) and matrix-stimulating efficacy which improves the clinical signs of skin aging in vivo. PATIENTS/METHODS: In vitro studies with pure Arctiin were performed investigating the inhibition of cytokine induction and stimulation of collagen neo-synthesis. In vivo home-in-use studies using an Arctium lappa fruit extract-containing formulation were carried out to determine procollagen and hyaluronan synthesis, hyaluronan synthase-2 gene expression, and reduction of wrinkle volume after treatment. RESULTS: In vitro studies on human dermal fibroblasts and monocyte-derived dendritic cells supplemented with pure Arctiin showed relative to untreated control cells a stimulation of collagen synthesis and a decrease in interleukin-6 and tumor necrosis factor-alpha concentration, respectively. In addition, topical in vivo application of an A. lappa fruit extract-containing formulation for 12 weeks significantly stimulated procollagen synthesis and increased hyaluronan synthase-2 expression as well as hyaluronan levels compared to vehicle-treated control areas. Similarly, after a 4-week treatment with an A. lappa fruit extract-containing formulation, wrinkle volume in the crow's feet area was significantly reduced as compared to treatment with the vehicle. CONCLUSIONS: Our data show that topical treatment with a natural A. lappa fruit extract significantly improves the metabolism of the dermal extracellular matrix and leads to a visible wrinkle reduction in vivo. In conclusion, A. lappa fruit extract represents a targeted means to regenerate dermal structures and, thus, offers an effective treatment option for mature skin.