In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.

Ultraviolet light enhances the generation of reactive oxygen species that are responsible for skin photoageing. The aim of this randomized, vehicle- and active-controlled double-blind, intra-individual monocentric study was to evaluate in situ the antioxidant activity of a dermo-cosmetic product in photoaged skin. Twenty healthy volunteers had defined skin areas randomized to receive a topical product containing 3 antioxidants (pre-tocopheryl® , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream. The products were applied daily for 30-day period. The skin areas were exposed to a controlled dose of UVA rays, and the skin oxidative status was evaluated 4 and 24 hours post-UVA exposure at D0 (basal value) and after 15 and 30 days of product application. Skin layers were collected by stripping, and antioxidant capacity was measured using the ferric reducing ability of a plasma assay. Lipid peroxidation (LPO) was assessed using the malonyldialdehyde test. The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO. The skin LPO level significantly decreased 4 and 24 hours after UVA exposure at 15 and 30 days. These findings were comparable to positive control treated sites and were significantly different from the vehicle and untreated sites. This minimally invasive methodology enabled a quantitative evaluation of potent antioxidant activity in situ in the stratum corneum reflecting real-life skin conditions and confirming the benefits of the topical application of a product containing 3 antioxidants in the prevention of UVA-induced oxidative damage.

Efficacy of D-pigment dermocosmetic lightening product for solar lentigo lesions of the hand: A randomized controlled trial.

Solar lentigo, benign lesions which mostly appear on chronically, sun-exposed surfaces, are associated with ageing. Patients are increasingly requesting a more uniform skin texture, especially for hands. Treatment options include dermoabrasion, intense pulsed light, cryotherapy, peelings, and laser therapy. Topical compounds can be employed, in alternative or associated with dermatologic procedures. The current study was designed to evaluate solar lentigo hyperpigmentation, skin architecture and clinician and patient assessments comparing a dermocosmetic lightening product (active) with a moisturizing product (control) according to clinical, digital and subjective analyses in 72 lesions over 12-month follow up period. Statistically significant differences were observed between the lesions treated with the active compared to the control in terms of papillary brightness (p = 0.03) and contrast (p = 0.03), and in the limitation of dermal-epidermal junction destructuring (p = 0.03) according to dermal-epidermal junction destructuring score at Reflectance Confocal Microscopy. Luminance (p = 0.04) and redness (p = 0.03) were improved at color analysis, and physician and patient evaluations favored the active in efficacy and patient satisfaction investigations. The dermocosmetic lightening product utilized in the current study proved to be more effective, according to clinical, digital and subjective analyses in reducing lesion hyperpigmentation, stabilizing the lesion skin architecture and increasing patient satisfaction compared to the control in a cohort of 36 subjects, over a 12-month period. Beside demonstrating the efficacy of this topical lightening product, we propose a "destructuring score", which improves the robustness of solar lentigo's evaluation, and can be used in future studies to standardize the quantitative comparisons of different treatment options.

Tolerability and Efficacy of a Medical Device Repairing Emollient Cream in Children and Adults with Mild to Moderate Atopic Dermatitis.

INTRODUCTION: Regular emollient application is recommended for managing atopic dermatitis (AD). Although many emollients are available, only AD-tested medical device repairing emollient creams (MDRECs) can be recommended for treating and preventing AD skin lesions. Here, we evaluated the tolerability and benefit of a new MDREC in an open-label study in infants, young children, and adults with mild to moderate AD. METHODS: Subjects (or their parents or guardians) were instructed to apply the MDREC to AD lesions or areas of dry skin twice daily for 3 weeks. Investigators assessed tolerability and AD severity at days 1, 8, and 22. Subjects assessed AD severity weekly, recorded any adverse events, and reported their satisfaction with the MDREC at day 22. RESULTS: Sixty-one subjects (19 infants, 22 children, and 20 adults) were included and 59 completed the study. At inclusion, 49% of the infants and young children and 15% of the adults were experiencing flares of AD. At day 22, the local tolerability of the MDREC was judged by the investigators as excellent in all the children and in 18 of the 20 adult subjects (90%). All adverse events were mild and transient. Investigator- and subject-assessed AD severity progressively decreased at each assessment for each age subgroup. CONCLUSION: This study shows that the MDREC was well tolerated when applied to AD skin lesions in infants, young children, and adults and suggests this product can be used daily to control the signs and symptoms of AD. FUNDING: Laboratoires Dermatologiques Ducray, Pierre Fabre Dermo-Cosmétique.

Correction to: Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study.

The original article can be found online.

Tolerability and efficacy of a medical device repairing emollient cream in adults with chronic hand dermatitis.

BACKGROUND: Emollients are recommended for managing chronic hand dermatitis (CHD). Medical device repairing emollient creams (MDRECs) are suitable for treating CHD-associated skin lesions, unlike most cosmetic emollient products that can only be used on healthy skin. OBJECTIVES: The aim of this study was to examine the tolerability and benefit of a MDREC, Dexyane MeD® , in adults with CHD. METHODS: In an open-label study, adults aged 18-65 years with mild-to-moderate CHD were instructed to apply the MDREC on both hands twice daily for 3 weeks. Investigators assessed tolerability and CHD severity on days 1, 8, and 22. Subjects assessed CHD severity weekly and completed the Dermatology Life Quality Index on days 1, 8, and 22. Differences from baseline were compared by Wilcoxon matched-pairs signed-rank test or paired t test. Satisfaction with the MDREC was assessed by subjects. RESULTS: Forty subjects were included and completed the study. Tolerability was good to excellent for all subjects. Subjects and investigators reported decreased severity of CHD at days 8 and 22 compared with Day 1 (P < 0.001), and subjects reported decreased pain and pruritus (P < 0.001). Quality of life improved, and most subjects were satisfied with the MDREC's characteristics and application. CONCLUSIONS: The MDREC was well tolerated and may help manage mild-to-moderate CHD.

A novel dermo-cosmetic product containing thermal spring water, sucralfate, copper sulfate, and zinc sulfate in the management of hand eczema.

BACKGROUND: The regular use of cosmetic products plays a role in the management of hand eczema (HE) and aids in improving barrier function reducing dryness, roughness, pruritus and improving quality of life (QoL). The aim of this open-label study was to assess the efficacy and the reparative effect of a dermo-cosmetic product on subjects suffering from HE after 7 and 21 days of daily application. METHODS: The product was a water-in-oil (W/O) emulsion containing the active ingredients Avène thermal spring water, sucralfate, and copper and zinc sulfates. In total, 32 subjects suffering from either contact dermatitis or climatic dermatitis participated in the trial. The modified total lesion symptom score and physician global assessment scores were used to describe the severity of HE. The safety of the product was assessed through clinical scoring. The subjective tolerance, and acceptance, were documented using a self-assessment questionnaire completed by the subjects. The impact of the dermatosis on QoL was evaluated using the Dermatology Life Quality Index. RESULTS: After 7 days of application, both the physician and subjects noticed a significant improvement in HE. The formula was very well tolerated and accepted. These benefits were correlated with a significant improvement in QoL. CONCLUSION: The W/O emulsion used in this study demonstrated real benefits for the subjects suffering from contact dermatitis and climatic dermatitis.

Antiaging efficacy of a retinaldehyde-based cream compared with glycolic acid peel sessions: A randomized controlled study.

BACKGROUND: Glycolic acid (GA) chemical peels are a popular treatment for photoaged skin rejuvenation, but retinaldehyde (RAL)-based cosmetic creams have also demonstrated efficacy in improving photoaging, and are potentially better tolerated than chemical peels. AIMS: To compare the efficacy and safety of an antiaging cream containing 0.1% RAL associated with Glycylglycine Oleamide (GGO, Relastide® ) and Pre-tocopheryl® , to GA peels sessions in the treatment of photoaging. PATIENTS AND METHODS: Fifty-five women with photoaging were randomized in 2 treatment groups: (1) Daily application of the antiaging cream for 8 weeks or (2) Three sequential GA peels (20%, 50%, and 70%), 2-3 weeks apart. Skin surface texture, length of wrinkles, complexion radiance, and evenness of pigmentation and texture were assessed by profilometry using skin replicas, computer image analysis, and self-assessment. RESULTS: Efficacy of both treatments was similar in reducing crow's feet wrinkles depth (STm -7.61%, P = .0007 vs -4.34%, P = .0348; P = .3049 intergroup) and volume, crow's feet and periorbital wrinkle length, and number of fine lines and wrinkles at end of treatments. The efficacy of the cream in refining skin texture was superior to the peels (contrast: -5.61%, P = .0025 vs +3.54, P = .08; P intergroup = .0252). The 8-week treatment with the antiaging cream was well tolerated; adverse events were fewer and of milder intensity than with the peels, (12-fold lower incidence of physical signs). CONCLUSION: A dermocosmetic cream containing 0.1% RAL, GGO (Relastide® ) and Pre-tocopheryl® is as effective as 3 sequential GA peels, better tolerated, and is an alternative in the management of photoaged skin.

Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study.

INTRODUCTION: Medical device repairing emollient creams (MDRECs) are designed to repair and protect the skin barrier. In this study, we examined the added clinical benefit and tolerability of a MDREC when used in association with a moderately potent topical corticosteroid (TCS) for adults with atopic dermatitis (AD). METHODS: This was an intra-individual randomized controlled trial in adults with moderate to severe AD (EudraCT no. 2014-002,194-10). Symmetrical lesions on each arm of the subjects were randomized to treatment for 10 days with twice-daily TCS (desonide) cream alone or with combined TCS + MDREC. Subjects were then included in a following 2-week maintenance phase if the AD on at least one test area had sufficiently improved so that the treatment was no longer needed. During the maintenance phase, treatment with the TCS cream was stopped, but twice-daily application of the MDREC was continued on the same test area previously assigned to receive it. The primary outcome measure was the change in local Scoring Atopic Dermatitis (SCORAD) index between day 1 and 3 based on investigators' assessment. Secondary measures of lesion severity included changes in the local patient-oriented SCORAD index, pruritus intensity according to subjects' assessments, and global assessments by subjects and investigators. RESULTS: The study included 54 subjects. The change in investigator-observed local SCORAD index between day 1 and 3 was - 14.4% with TCS alone and - 24.5% for TCS + MDREC (p = 0.0005). Between baseline and the end of the treatment phase, all secondary measures of lesion severity decreased more with the combined TCS + MDREC treatment than with the TCS cream alone. The MDREC also reduced the relapse of AD lesions during the maintenance phase. Tolerability was very good, and the product was well accepted by subjects. CONCLUSION: These results support using the MDREC in association with TCS during AD flares and as a maintenance therapy after treatment with TCS has stopped. FUNDING: Laboratoires Dermatologiques Ducray, Pierre Fabre.

Visualization of dendritic cells' responses in atopic dermatitis: Preventing effect of emollient.

Atopic dermatitis (AD) is a chronic and multifactorial inflammatory skin disease involving various dendritic cells such as epidermal Langerhans cells (LC) and inflammatory dendritic epidermal cells (IDECs). Most of the clinical studies was performed on isolated cells, and thus, it would be useful to characterize directly on the human epidermal tissue the first cellular events occurred during the AD. The suction blister method was used to obtain whole epidermis samples and interstitial cutaneous fluids. Employing multiphoton microscopy, we analyzed the early dynamic behavior of inflammatory cells using Dermatophagoides pteronyssinus atopy patch test (Derp-APT) and evaluated the effects of emollient pre-application. Derp-APT application provoked rapid and strong infiltration of IDECs, and proliferation and activation of LC in the AD subjects' epidermis. Moreover, emollient pre-application strengthened the defective skin barrier and had positive effects on inflammatory cells' behavior, characterized by the complete inhibition of IDEC influx and the presence of immature LC.

Ultraviolet radiation and the skin: Photobiology and sunscreen photoprotection.

The efficacy of sunscreens can be measured by different methods, involving in vitro, ex vivo, or in vivo techniques. There is a need for a worldwide standardization of these methods to avoid misunderstanding and confusion among sunscreen users. The clinical benefits of sunscreens have been demonstrated in randomized controlled trials that established the role of sunscreens in the prevention of actinic keratoses, squamous cell carcinomas, nevi, and melanomas. Sunscreens also prevent photoimmunosuppression and signs of photoaging. Continued efforts in public education on the proper application of sunscreens and the practice of photoprotection in general are needed.

Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study.

Although acne vulgaris is common in preadolescents (<13 yrs), few acne treatments are currently approved for children. This study assessed the safety and efficacy of tretinoin microsphere gel (TMG) 0.04% pump in children aged 9-11 with acne vulgaris. In this multicenter, randomized, double-blind, vehicle-controlled pilot study, patients applied TMG 0.04% pump or vehicle once daily to the face for 12 weeks. Efficacy measures were changes in facial lesion counts, Investigator Global Evaluation of acne severity using two scales, and Investigator Global Assessment of Improvement from baseline to week 12. Of the 110 patients enrolled, 55 received TMG 0.04% pump, and 55 received vehicle. At week 12, there was significantly greater improvement in the least-squares mean change in noninflammatory lesions with TMG 0.04% than with vehicle (-19.9 vs -9.7, p = 0.04) and a significant difference in Investigator Global Assessment of improvement at week 12 between the children treated with TMG 0.04% pump and those treated with vehicle (p = 0.02), but there were no discernible differences in static acne severity scales. Change from baseline in signs and symptoms of cutaneous irritation were similar between the active and vehicle arms at week 12. This study demonstrated statistically significant differences in the reduction of noninflammatory lesions between TMG 0.04% pump and vehicle in patients aged 9-11 with acne vulgaris. Additional studies are warranted to further characterize the safety and efficacy of TMG 0.04% pump for the treatment of acne in the preadolescent population.

Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.

Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris. The primary efficacy endpoint was the change from baseline in total acne lesions; the primary safety endpoint was the change in cutaneous irritation scores. The 247 participants (mean age: 18.5 years) were randomized to either the morning/morning regimen (n = 123) or the morning/evening regimen (n = 124). The morning/morning regimen was determined to be non-inferior to the morning/evening regimen in reduction of total acne lesions. The tolerability of both regimens was comparable. The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris.

Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel.

This single-center, investigator-blinded, randomized, split-face, phase 4 study compared the irritation potential of tretinoin gel microsphere (TGM) 0.04% in a pump dispenser with adapalene 0.1% plus benzoyl peroxide 2.5% gel (ADA-BPO 0.1%/2.5%) in a panel of 170 subjects. Participants were treated with TGM 0.04% pump on a randomly assigned side of the face and ADA-BPO 0.1%/2.5% gel on the other side of the face daily for three consecutive weeks. Expert grader assessments of erythema and dryness and subject self-assessments of burning/stinging and itching were conducted daily, except on weekends. TGM 0.04% pump was associated with better facial tolerance as demonstrated by significantly less cumulative erythema (P < 0.0001), dryness (P < 0.0001), burning/stinging (P < 0.0001) and itching (P < 0.0001) compared with ADA-BPO 0.1%/2.5% gel. While both agents were well tolerated by most patients, TGM 0.04% pump demonstrated significantly better tolerance than ADA-BPO 0.1%/2.5% gel in both neurosensory parameters and signs of contact irritation.

Phase 4 study to assess tretinoin pump for the treatment of facial acne.

It is well known that the setting of clinical trials for registration studies do not necessarily represent efficacy seen in clinical practice, where physicians have the flexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label, multicenter, community-based study, 544 patients who were dissatisfied with their current acne treatment received tretinoin gel microsphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was high (defined as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At week 12, the mean modified Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated significant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compliance.

Use of autologous fibrin glue in dermatologic surgery: application of skin graft and second intention healing

Objective: To evaluate the efficiency of biological sealant, an autologous fibrin glue, in dermatological surgery. Design: Randomized clinical trial Setting: The Dermatology Service of Hospital das Clinicas, Universidade de Campinas (UNICAMP), referral center. Patients: 14 patients with malign epithelial cutaneoos tumors participated in the evaluation, each having two tumors, generally facial and symmetrical, in order to perform a comparative evaluation on the same individual. Procedures: The glue was prepared beforehand with a sample of autologous blood. Surgical extirpation of the tumor was followed by grafts or second intention healing. Outcomes: The efficiency of the sealant was then evaluated in relation to hemostasis, adhesion, surgical time and evolution of the granulation tissue, clinically and histologically. Results: Immediate hemostasis and graft adhesion, with a significant reduction of surgical time, and in the open wounds there was immediate hemostasis and a clinical increase in granulation tissue, but with no histological differences among the groups on the 7th day. Conclusion: It is an adjuvant resource in skin cancer surgery.