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Introduction Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel. Methods This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated. Results On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUCdays 2–12 p

Background: Dexpanthenol containing formula (BEPANTHEN®), formulated as a water in oil preparation, is currently widely marketed as a diaper care product aiming to protect baby’s buttocks and repair diaper dermatitis. Dexpanthenol is a well-known moisturizer with barrier-improving properties and the oily phase of the water in oil preparation forms a lipophilic film on the skin surface that isolates the skin from irritants (feces and urine). Prolonged contact with irritants triggers a local inflammation cascade responsible for the cutaneous erythema. To further investigate the protective properties of skin barrier preparations, we took advantage of an ex vivo model of healthy human skin discs especially designed to evaluate protective and/or repairing effects of topical preparations recommended for baby’s buttocks through the measurement of interleukin-1 alpha release (a cytokine considered as the Primum movens of the skin inflammatory reaction), following the application of different irritants. Methods: Healthy human skin discs have been incubated in the absence (control) or in the presence of two irritants, i.e. a “urine like + urease” preparation and sodium dodecyl sulfate, and in the presence of three ointments, one containing dexpanthenol, but not the other two. At the end of the incubation period, interleukin-1 alpha (IL-1α) was quantified in the explants culture media. Results: “Urine like + urease” preparation (ULU) and sodium dodecyl sulfate (SDS) both increased IL-1α production of skin explants by 181.1% (p α release by 67.42% (p α release by 45.94% (p α production regardless of the irritant applied. Moreover, the effect of the dexpanthenol containing formula on the ULU-induced IL-1α release was significantly higher than the effect of the other formula; a difference of 19.6 % (p ®) provides good protection of baby’s buttocks against irritants. Its protective effect seems to be superior compared with other products, which did not contain this ingredient. Moreover, the results obtained in the present study suggest that dexpanthenol displays per se a real IL-1α production inhibitory effect. This work, however, consists of preliminary studies and additional investigations involving more formulas and end-points such as the quantification of other pro- or anti-inflammatory cytokines and/or resolvins for example, are needed to better understand the cutaneous protective effect of dexpanthenol.

Two novel body/face wash gels enriched with emollient ingredients (including dexpanthenol) were developed for the daily care of dry skin. Two similarly designed 2-week studies (N = 42 each) were conducted to assess the biophysical and cosmetic performance of each of the new wash gels in healthy adults with dry skin. Instrumental measurements quantified the effects of the wash gels on stratum corneum (SC) hydration and transepidermal water loss (TEWL) (with and without a previous sodium lauryl sulfate (SLS) challenge) after single and repeated usage. Following single and repeated applications of the face wash gel to facial skin, as well as to dry SLS-undamaged and SLS-damaged skin of the forearm, skin hydration significantly increased. Similarly, after single and repeated usage of the body wash gel to dry SLS-undamaged and SLS-damaged skin of the forearm, skin moisturization increased significantly from baseline, comparisons with control areas provided inconsistent results for SLS-undamaged skin. No effects on TEWL were observed for either product. Both wash gels were well tolerated and the cosmetic performances were appreciated by the subjects. The study results suggest that daily use of the new wash gels was associated with significant skin-moisturizing effects without adversely affecting skin barrier function and repair.

Three novel face creams containing dexpanthenol with different lipid contents were developed for dry skin sufferers: a day face cream (DFC), a day face cream with sun protection (DFC-SPF), and a night face cream (NFC). Three identically designed studies (N = 42–44 each) were conducted with healthy adults of three ethnicities (African, Asian, Caucasian) with dry/sensitive skin. Effects on stratum corneum (SC) hydration, SC lipid content, and skin elasticity were quantified by established noninvasive methods during the 4-week studies. After single and repeated once-daily applications of the face creams, facial hydration significantly increased from baseline. On day 28, the mean increments in skin hydration amounted to 27%, 26%, and 27% (p &lt, 0.0001 each) for DFC, DFC-SPF, and NFC, respectively. Favorable effects of DFC, DFC-SPF, and NFC on facial moisturization were observed in all three ethnic groups. The enhancements in SC hydration were not paralleled by improvements in skin elasticity parameters but lipid analyses showed significant increases in SC cholesterol, SC free fatty acid, and/or SC ceramide levels. All three face creams were well tolerated and achieved a high product satisfaction and acceptability by study participants. Our findings support the once-daily use of the face creams in adults of different ethnicities with dry and sensitive skin.

Moisturizers are commonly prescribed after laser and chemical peel aesthetic procedures, but the evidence regarding their efficacy and safety of such use is scarce. We conducted four single-blind, three-week, controlled studies to evaluate the efficacy and safety of topical Dexpanthenol-containing products (Bepantol® spray and Bepantol® cream) using petroleum jelly as a positive control. Skin recovery was assessed after four aesthetic procedures: (1) non-ablative facial laser resurfacing, (2) laser depilation on the external genital and inguinal regions, (3) chemical peel on the external genital and inguinal regions, and (4) ablative facial laser resurfacing. Efficacy was assessed through transepidermal water loss (TEWL) combined with clinical assessment of the skin by the investigators and the participants. In studies (1) and (4), the erythema intensity was evaluated by measuring dermal temperature with a thermal imaging camera. Safety was assessed through adverse event reporting and acceptability through a questionnaire. Dexpanthenol-containing products significantly decreased TEWL and dermal temperature, therefore maintaining skin integrity, promoting its recovery, and reducing erythema. No statistical differences with the positive control were observed. In addition, Dexpanthenol-containing products were well appreciated by the participants from a sensory perspective. These findings suggest that these Dexpanthenol-containing products are adequate for post-procedural care in aesthetic dermatology.

Three studies were conducted with three new dexpanthenol-containing emollients containing increasing lipid contents (Emollients 1–3) to assess their performances in healthy adults with dry skin. All three studies (N = 42 each) followed virtually the same design. A single skin application of the study product was performed followed by once-daily usage. Skin hydration, transepidermal water loss (TEWL), skin biomechanical properties, and lipid content of the stratum corneum (SC) were regularly assessed over the 28-day study period, a subset (N = 22) underwent a sodium lauryl sulfate (SLS) challenge prior to product application. All three emollients were well tolerated and showed good performances with only minor differences in instrumental measurements. After single and prolonged once-daily applications of Emollients 1–3 to dry skin and dry SLS-damaged skin, skin hydration significantly increased from baseline (BL) (by 38.1–72.4% in unchallenged skin, p &lt, 0.001 for all three). This was paralleled by significant increases in skin elasticity parameters. Usage of Emollients 1 and 3 caused increases from BL in SC cholesterol (by 9.8–12.5%, p &lt, 0.05 for both) and SC free fatty acid levels (by 3.7–26.3%, p &lt, 0.05 for both) at the end of the study. No sustained effects on TEWL were recorded. Our findings support the once-daily use of all three emollients in adults with dry skin.

Approximately 70 years ago, the first topical dexpanthenol-containing formulation (Bepanthen™ Ointment) has been developed. Nowadays, various topical dexpanthenol preparations exist, tailored according to individual requirements. Topical dexpanthenol has emerged as frequently used formulation in the field of dermatology and skin care. Various studies confirmed dexpanthenol's moisturizing and skin barrier enhancing potential. It prevents skin irritation, stimulates skin regeneration and promotes wound healing. Two main directions in the use of topical dexpanthenol-containing formulations have therefore been pursued: as skin moisturizer/skin barrier restorer and as facilitator of wound healing. This 70th anniversary paper reviews studies with topical dexpanthenol in skin conditions where it is most frequently used. Although discovered decades ago, the exact mechanisms of action of dexpanthenol have not been fully elucidated yet. With the adoption of new technologies, new light has been shed on dexpanthenol's mode of action at the molecular level. It appears that dexpanthenol increases the mobility of stratum corneum molecular components which are important for barrier function and modulates the expression of genes important for wound healing. This review will update readers on recent advances in this field.

The objective of this study is to investigate the effect of a newly developed calcium carbonate-vitamin D₃ chewable tablet formulation (600 mg of calcium + 400 IU of vitamin D₃) on serum/urine calcium and serum parathyroid hormone (PTH) as measures of intestinal calcium absorption compared to a placebo.This is a subject-blind, sequential study in 24 healthy postmenopausal women. Each subject received two placebo tablets once daily for 3 days (days -3 to -1) immediately followed by two calcium-vitamin D₃ tablets (test) during the subsequent 3 days (days 1-3). Serial blood sampling and 24-h urine collection took place on days -1 and 3. The subjects fasted until 6 h post-dosing. Total urinary calcium excretion (Ae(0-24 h)) and AUC(0-6 h) for serum calcium were the primary outcome variables and were compared between treatments using a paired sample t-test.Ae(0-24 h) increased by 42% (uncorrected, p = 0.0001) and 30% (creatinine-corrected, p = 0.0001), after intake, compared with the placebo; serum calcium exposure (AUC(0-6 h)) was also, statistically, significantly greater. PTH, in serum, decreased by 28% (AUC(0-6 h), p = 0.0001) and 14% (AUC(0-24 h), p = 0.0009) when compared with the placebo.Daily intake of 1200 mg of calcium and 800 IU of vitamin D₃, with a new chewable tablet, resulted in increased intestinal calcium absorption compared to the results from the placebo as confirmed by direct and indirect pharmacokinetic/pharmacodynamic measures.

Lactoferrin, an innate defense iron-binding protein, possesses antimicrobial and anti-inflammatory activities. Beneficial systemic effects on inflammatory diseases have been proposed. The aim of the present study was to explore the efficacy and tolerability of oral bovine lactoferrin supplementation in subjects with mild to moderate facial acne vulgaris.In this open-label, single-arm study, 43 adolescents and young adults were enrolled to take a chewable tablet formulation of bovine lactoferrin twice daily for 8 weeks. The primary efficacy endpoint was the improvement in acne lesion counts compared with baseline. Tolerability was evaluated on the basis of adverse event frequencies.Thirty-nine subjects, aged 17.5 ± 3.8 years, completed the study per protocol. At the end of the study (week 8), a mean reduction in inflammatory lesion count of 20.2% (-2.2 ± 7.0, p = 0.054), in non-inflammatory lesion count of 23.5% (-6.2 ± 9.8, p 0.001), and in total lesion count of 22.5% (-8.4 ± 13.1, p 0.001) was observed as compared with baseline. At study conclusion, 76.9% (30 of 39) of subjects showed a reduction in total lesion count. The results for inflammatory acne lesions were variable over the study course. None of the subjects experienced a lactoferrin-related adverse event during the trial.Despite the limitations of an uncontrolled, open-label study, the results from this study indicate that lactoferrin in mild to moderate acne vulgaris is well tolerated and may lead to an overall improvement in acne lesion counts in the majority of affected adolescents and young adults when administered as a dietary supplement on a twice daily regimen. Further randomized, placebo-controlled trials of longer duration appear warranted.

International audience; Pediatric drug formulations of artemisinin combination therapies are urgently needed for improving the treatment of children suffering from uncomplicated malaria. The aim of this clinical trial was to evaluate the efficacy, safety and tolerability of a novel pediatric fixed-dose granule formulation of artesunate-mefloquine and a new co-blister tablet formulation. A total of 71 children aged 1-13 years suffering from uncomplicated falciparum malaria were stratified into two groups according to weight: 10-20 kg, pediatric group (n = 41); 20-40 kg, tablet group (n = 30). All the children were treated once daily for three days: the pediatric group received the novel granule formulation, the tablet group received the co-blister tablets. The PCR-corrected cure rate on day 28 was evaluated. There was no reappearance of parasitemia during the follow-up period and the day-28 cure rate was therefore 100% in per-protocol analysis. In intention-to-treat analysis the cure rates were 95% in the pediatric group and 97% in the tablet group. The most frequent adverse events were vomiting (17%), abdominal pain (11%) and headache (17%). This study confirms the excellent efficacy and favorable safety and tolerability profile of a novel pediatric artesunate-mefloquine formulation for treatment in African children.