Double-blind Vehicle-controlled Study Research Articles

Efficacy and Safety of Ruxolitinib Cream Among Children With Atopic Dermatitis Aged 2 to 6 Years and 7 to <12 Years: Results from a Phase 3 Double-Blind Vehicle-Controlled Study

Efficacy and Safety of Ruxolitinib Cream Among Children With Atopic Dermatitis Aged 2 to 6 Years and 7 to <12 Years: Results from a Phase 3 Double-Blind Vehicle-Controlled Study

Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis.

Background: Preliminary studies support the use of topical coconut and sunflower seed oil for atopic dermatitis (AD). However, standardized topical formulations of fatty acids from these sources have not been studied. Objective: This study investigates whether coconut oil- and sunflower seed oil-derived isosorbide diesters can be used in conjunction with colloidal oatmeal to improve itch, AD severity, and the need for topical steroids in adults. Methods: This was a single-center, 4-week, randomized, double-blind, and vehicle-controlled study conducted between 2021 and 2022. Thirty-two male and female adults with mild-to-moderate AD were enrolled and completed the study. Participants were randomized to receive either 0.1% colloidal oatmeal (vehicle) or isosorbide diesters (IDEAS, 4% isosorbide dicaprylate and 4% isosorbide disunflowerseedate) along with 0.1% colloidal oatmeal. The main outcomes of the study were changes in the visual analogue rating of itch and 75% improvement in the Eczema Area and Severity Index score (EASI 75) at 4 weeks. Other measures included the use of topical steroids and the relative abundance of skin Staphylococcus aureus. Results: Participants in the IDEAS group had a 65.6% improvement in itch compared with 43.8% in the vehicle group (P = 0.013). In total, 56.5% and 25% of the those in the IDEAS and vehicle groups, respectively, achieved EASI 75 at 4 weeks (P = 0.07). There was no difference in skin hydration or transepidermal water loss. The relative abundance of S. aureus was decreased in the IDEAS group at week 4 compared with no change in the vehicle group (P = 0.044). Topical corticosteroid use increased in the vehicle group compared with a decrease in the IDEAS group at week 1 (292.5% vs 24.8%; P value = 0.039) and week 2 (220% vs 46%; P value = 0.08). Conclusions: Topical application of emollients containing coconut oil- and sunflower seed oil-derived fatty esters may improve itch, reduce topical steroid use, and reduce the relative abundance of S. aureus in mild-to-moderate AD. CTR number: NCT04831892.

Reduction of telogen rate and increase of hair density in androgenetic alopecia by a cosmetic product: Results of a randomized, prospective, vehicle-controlled double-blind study in men.

Considerable parts of the global population are affected by androgenetic alopecia (AGA). The efficacy of a foam containing nicotinic acid hexyl ester, polyphenols, zinc, glycine, and caffeine in comparison with a vehicle control foam was assessed in a double-blind vehicle-controlled study in men with AGA over 6months. Sixty-two men with AGA were assigned either to the active ingredients (verum) or the vehicle group. They applied the products twice daily on affected scalp areas over 6months. Automated phototrichograms were obtained at baseline, after 3 and 6months. In addition, a clinical rating by a dermatologist and by the subjects themselves was documented using standardized questionnaires. The reduction of the telogen rate from T0 to T6 was significantly stronger in the verum group compared to the vehicle group. The reduction was significant from T0 to T3 and T6 in the verum group, but in the vehicle group only from T0 to T3, not to T6. Significantly increased hair density was noticed in both groups at all time points, but the change from T0 to T6 did not differ significantly between the groups. Cosmetic acceptance of the foam and its application regimen was generally good in both groups. Slight reddening and burning after application of verum in six cases was probably due to the presence of hexyl nicotinate. The study demonstrated a reduction of the telogen rate by a cosmetic foam in men affected by AGA, indicating a benefit for cosmetic intervention against male pattern hair loss.

Effect of Gentamicin Ointment in Patients with Nagashima-type Palmoplantar Keratosis: A Double-blind Vehicle-controlled Study.

Gentamicin ointment has potential in the treatment of Nagashima-type palmoplantar keratosis. However, there is a lack of reliable study data. The aim of this study was to perform a prospective, randomized, double-blinded, contralateral, vehicle-controlled clinical trial. A total of 20 subjects diagnosed with Nagashima-type palmoplantar keratosis by genetic test, who carried nonsense mutations, enrolled in the 30-day study. Gentamicin ointment was applied to the hand and foot on one side of the body, and vehicle ointment was applied to the hand and foot on the other side. The choice of hand and foot in each subject was randomly allocated. The severity of the patient’s skin lesions and quality of life were assessed by a blinded evaluator, using the Dermatology Life Quality Index, visual analogue scale scores and digital photography. Gentamicin ointment treatment resulted in a significant improvement in symptoms of hyperkeratosis and foul smell compared with vehicle. No difference was found in the effect on erythema between gentamicin and vehicle. In conclusion, gentamicin ointment demonstrated positive responses and good tolerance in treating Nagashima-type palmoplantar keratosis caused by nonsense mutations.

Chitin-Hyaluronan Nanoparticles: A Multifunctional Carrier to Deliver Anti-Aging Active Ingredients through the Skin

The paper describes the process to produce Chitin Nanofibril-Hyaluronan nanoparticles (CN-HA), showing their ability to easily load active ingredients, facilitate penetration through the skin layers, and increase their effectiveness and safety as an anti-aging agent. Size and characterization of CN-HA nanoparticles were determined by Scanning Electron Microscopy (SEM) and Zetasizer, while encapsulation efficiency and loading capacity of the entrapped ingredients were controlled by chromatographic and spectrophotometric methods. Safeness was evidenced on fibroblasts and keratinocytes culture viability by the MTT (Methylthiazol) assay; anti-aging activity was evaluated in vitro measuring antioxidant capacity, anti-collagenase activity, and metalloproteinase and pro-inflammatory release; efficacy was shown in vivo by a double-blind vehicle-controlled study for 60 days on 60 women affected by photo-aging. In addition, the CN-HA nanoparticles have shown interesting possibility to be used as active ingredients, for designing and making advanced medication by the electrospinning technology, as well as to produce transparent films for food packaging, by the casting method, and can be used also in their dry form as tissues or films without adding preservatives. These unusual CN-HA nanoparticles obtained from the use of raw materials of waste origin may offer an unprecedented occasion for making innovative products, ameliorating the quality of life, reducing pollution and safeguarding the environment’s integrity.

Interaction of mineral salts with the skin: a literature survey

There is growing scientific evidence that the health, well-being and the attractiveness of the skin are strongly influenced by nutrition. Consumers recognize this and have supported the creation of a global cosmeceuticals market estimated in 2010 at $27.2 billion. Early in 2011, the US Department of Health and Human Services and Department of Agriculture issued the Dietary Guidelines for Americans, 2010. Twelve vitamins and nine minerals were recognized as essential. The minerals include calcium, copper, iron, magnesium, phosphorus, selenium, zinc, potassium and sodium. Although the topical benefits of several minerals such as zinc, magnesium and iron are recognized and, in some cases, approved by the FDA, the topical benefits of the others to the skin are largely unexplored and unexploited. This review attempts to summarize what has been published in the literature on the interactions of the eight of the nine essential elements with the skin.

Pimecrolimus cream 1% in erosive oral lichen planus–a prospective randomized double-blind vehicle-controlled study

Pimecrolimus cream 1% in erosive oral lichen planus–a prospective randomized double-blind vehicle-controlled study

Erratum

British Journal of DermatologyVolume 159, Issue 4 p. 944-944 Free Access Erratum This article corrects the following: Pimecrolimus cream 1% in erosive oral lichen planus— a prospective randomized double-blind vehicle-controlled study T. Volz, U. Caroli, H. Lüdtke, M. Bräutigam, H. Kohler-Späth, M. Röcken, T. Biedermann, Volume 159Issue 4British Journal of Dermatology pages: 936-941 First Published online: July 21, 2008 First published: 17 September 2008 https://doi.org/10.1111/j.1365-2133.2008.08843.xAboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Pimecrolimus cream 1% in erosive oral lichen planus—a prospective randomized double-blind vehicle-controlled study. Br J Dermatol 2008, Volz et al. Table 1 in the above mentioned article1, was incorrectly published. The data should have been presented as follows: Table 1. Demographic data and clinical characteristics of the study population at baseline visit Pimecrolimus cream 1% (n = 10) Vehicle cream (n = 10) Age (years), mean ± SD 59·4 ± 13·2 59·4 ± 9·0 Age (years), range 35–73 47–71 Sex (male/female) 3/7 2/8 Duration of EOLP (months), mean ± SD 16·1 ± 11·1 12·4 ± 10·6 Composite score, mean ± SD 6·19 ± 1·74 6·70 ± 2·58 Erosive area, mean ± SD 1·40 ± 0·52 1·90 ± 0·74 Continuous pain (VAS), mean ± SD 4·99 ± 2·32 4·56 ± 3·61 Meal-triggered pain (VAS), mean ± SD 6·99 ± 1·92 7·44 ± 2·60 The area of erosive oral mucosa was determined as described in the Patients and methods section. The degree of pain is shown as mean ± SD of the VAS used. No significant differences between both treatment groups in the parameters observed could be detected. EOLP, erosive oral lichen planus; VAS, visual analogue scale. The Journal apologises for this error. Reference 1 Volz T., Caroli U., Lüdtke H. et al. Pimecrolimus cream 1% in erosive oral lichen planus—a prospective randomized double-blind vehicle-controlled study. Br J Dermatol 2008; 159: 936– 41. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar Volume159, Issue4October 2008Pages 944-944 ReferencesRelatedInformation

Pimecrolimus cream 1% in erosive oral lichen planus- a prospective randomized double-blind vehicle-controlled study

Erosive oral lichen planus (EOLP) is a T-cell mediated inflammatory disease leading to severe pain and impairment. As current therapies are of limited efficacy, application of calcineurin inhibitors is considered to be a potential option. To investigate the efficacy of pimecrolimus cream 1% (Elidel) compared with vehicle cream in the treatment of EOLP. Twenty patients were enrolled in a prospective, double-blind, randomized, vehicle-controlled trial and assigned to either pimecrolimus or vehicle group. Study medication was applied for 30 days followed by 30 days of observation without therapy. In case of unresponsiveness, treatment was continued for 30 days with open-label pimecrolimus. EOLP was monitored on days 0, 30 and 60. Safety was assessed by patient documentation, measurement of pimecrolimus levels and blood counts. Within 30 days erosions cleared completely in seven of 10 patients treated with pimecrolimus and in two of 10 patients treated with vehicle. The clinical EOLP 'composite score' including mucosal erosions and pain sensation was significantly reduced in the pimecrolimus-treated group compared with vehicle (P = 0.025). In the three of 10 patients not responding to pimecrolimus, EOLP cleared after an additional 30 days of treatment with pimecrolimus. Following termination of the therapy, sustained remission of EOLP was detected in 83% of patients demonstrating long-lasting effects of pimecrolimus treatment. No severe adverse events were observed. In five patients pimecrolimus blood levels were detected, all of which stayed below 4 ng mL(-1). Pimecrolimus cream 1% effectively treats EOLP with long-lasting therapeutic effects and is therefore a promising therapeutic option for EOLP.

Combined 0.1% Retinaldehyde/ 6% Glycolic Acid Cream in Prophylaxis and Treatment of Acne Scarring

Background: Acne often results in permanent, badly tolerated, difficult to treat scars. Objective: To evaluate the efficacy and safety of a 0.1% retinaldehyde/6% glycolic acid (RALGA) cream at preventing and treating acne scarring in patients previously treated for moderate acne. Methods: A double-blind vehicle-controlled study was conducted in 145 patients randomized to apply RALGAor vehicle cream every evening for 3 months. Global scarring score and patient’s assessment of global efficacy, then residual acne lesions, quality of life and tolerance were evaluated at inclusion and each month until study completion. Results: Global scarring score, number of inflammatory lesions and comedones significantly improved in each group from day 28 (p < 0.0001). Number of inflammatory lesions were significantly decreased only in the RALGA group. RALGA cream was more efficient than vehicle on scarring after 3 months in compliant patients (p = 0.007) due to erythema and hyperpigmentation improvement. Conclusion: RALGA cream is efficient at preventing and treating acne scarring in patients with moderate acne.

Efficacy and safety of Eucerin 10% Urea Lotion in the treatment of symptoms of aged skin

Two features of senescent skin are dryness and itching, which are caused by a reduced water-binding capacity of the stratum corneum. Urea, topically applied, is known to increase the water content of the stratum corneum and thereby improves the symptoms of dry and itching skin. The aim of the study was to compare the efficacy and safety of a lotion containing 10% urea (Eucerin® 10% Urea Lotion) with that of the urea-free lotion base in the treatment of the symptoms of aged skin. In a randomized double-blind vehicle-controlled study with a semilateral design, 60 elderly volunteers (mean age 64.1 years) with characteristic symptoms of aged but otherwise healthy skin were treated over a period of 4 weeks. The study protocol used surface moisture content of the forearm skin as determined by corneometry as the primary efficacy criterion and subjective symptoms (dryness, itching) as secondary efficacy criteria. Eucerin 10% Urea Lotion proved to be superior to its vehicle in increasing skin hydration, as shown by changes in corneometric moisture levels from baseline to the last visit (P<0.0001). The subjective assessments of skin dryness and itching decreased during treatment with both the active lotion and the vehicle. The skin compatibility of Eucerin 10% Urea Lotion was very good.

The influence of sex hormones on UVB induced erythema in man

Clinical and experimental evidence suggests that sex hormones can modify the inflammatory response in a number of diseases. In a pilot study the influence of sex hormones on UV-induced inflammation, testing was done with oestradiol-17β, testosterone and progesterone, as a double-blind vehicle-controlled study in 47 healthy volunteers. Inflammation was graded using laser-doppler velocimetry. Oestradiol (5 mg/100 g) was found to increase the inflammatory response significantly when compared with placebo or testosterone treated areas ( P < 0.03). These findings support previous experimental and epidemiological observations of an increased inflammation following oestrogenic stimulation, and suggest that non-lymphocyte-mediated mechanisms may be involved as well.

A double-blind vehicle-controlled study of R 68 151 in psoriasis: A topical 5-lipoxygenase inhibitor

Recently the pharmacologic role of leukotrienes (LTs), especially that of LTB4, has been intensively investigated in psoriasis. In vitro, R 68 151 is a potent 5-lipoxygenase inhibitor and consequently reduces LTB4 formation. Therefore the role of an in vitro 5-lipoxygenase inhibitor and its clinical use in psoriasis were evaluated with topical R 68 151 in a double-blind vehicle-controlled study. Eighty-eight patients with localized psoriatic lesions were treated twice daily with R 68 151 2% ointment (n = 44) or vehicle ointment (n = 44) during 4 weeks. Most patients (n = 73) had psoriasis vulgaris (n = 37, R 68 151; n = 36, vehicle). In 27% of the R 68 151-treated patients with psoriasis vulgaris, the lesions disappeared or showed marked improvement, compared with 8% in the vehicle group (X2, p = 0.06). The scores in global evaluation, however, were significantly different between both treatment groups (p less than 0.05, Mann-Whitney U test). The improvement of the mean symptom score with R 68 151 was 46% for scaling and 34% for erythema at the end of the study compared with an improvement of 6% and a deterioration of 3%, respectively, in the control group (p less than 0.05, p less than 0.01; Mann-Whitney U test). The global evaluation in the total group of patients with psoriasis (all different subtypes) was consistent with the response rate in the group of patients with psoriasis vulgaris: 30% in the test group versus 11% in the control group (X2, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

CORRECTION

In the correction published in the June 10 issue ofTHE JOURNAL(1988;259:3274) on "Topical Tretinoin Improves Photoaged Skin: A Double-blind Vehicle-Controlled Study" (1988;259:527-532), the values in brackets should be transposed and should read as follows: "... increase in mean epidermal thickness of 82% [not '273%']... (...<i>P</i>&lt;.0001 [not '<i>P</i>=.026'])."

CORRECTION

Some errors occurred in the ORIGINAL CONTRIBUTION entitled "Topical Tretinoin Improves Photoaged Skin: A Double-blind Vehicle-Controlled Study," published in the Jan 22/29 issue ofThe Journal(1988;259:527-532). Table 3 is reprinted below with the corrections. Corresponding changes in the text occur on page 529, column 3, sentence 3 and read as follows: "... increase in mean epidermal thickness of 82% [not '<i>P</i>=.026']... (..<i>P</i>&lt;.0001 [not '273%'])." The remaining results and the entire "Comment" section and conclusions in the original article are unaffected by the revisions.

Topical tretinoin improves photoaged skin. A double-blind vehicle-controlled study

Topical tretinoin improves photoaged skin. A double-blind vehicle-controlled study