Retrospective study on the safety and tolerability of clinical treatments with a novel Thermomechanical Ablation device on 150 patients.

INTRODUCTION: There are currently not many publications on the safety of thermomechanical ablation (TMA) devices, and those that are published only have small numbers of subjects. This treatment is gaining popularity in Europe and Asia, and thus there is a need to look at the safety of this treatment. OBJECTIVE: The purpose of this retrospective study was to evaluate the safety of the clinical use of the novel TMA system (Tixel, Novoxel, Israel) for facial rejuvenation and treatment of acne scars. METHODS: We did a retrospective review of our first 150 patients who were treated with the TMA device. RESULTS: One hundred and fifty consecutive patients aged 20 years to 82 years with Fitzpatrick skin types I to V treated with the TMA device were included in this study. The total number of treatment sessions was 327 (average 2.18 treatment per patient). The total number of pulses delivered to these patients was 1 48 856 (average 455 pulses per session). The indications for the treatment were photodamaged skin (n=145) and acne scarring (n=5). All patients were able to use makeup immediately after the treatment at lower settings, thus needing no real recovery time. Patients treated at higher settings were able to use makeup after 2 days. There were four reported complications: post-inflammatory hyperpigmentation (n=2), impetigo (n=1), and dermatitis (n=1). CONCLUSIONS: Using the TMA device in the treatment of photodamage and acne scarring is safe in skin types I to V and has a low incidence of temporary side effects with no permanent side effects.

Thermo-Mechanical Fractional Injury Therapy for Facial Skin Rejuvenation in Skin Types II to V: A Retrospective Double-Center Chart Review.

BACKGROUND AND OBJECTIVES: Thermo-mechanical fractional injury (TMFI) therapy (Tixel®; Novoxel®, Netanya, Israel) is an innovative technology. Along with its drug delivery enhancement features, it is widely used for facial skin rejuvenation. Our study explores the beneficial effect of the Tixel® on the different features of facial skin rejuvenation along with patients' satisfaction rate, aiming to suggest practical recommendations for an optimal aesthetic result. STUDY DESIGN/MATERIALS AND METHODS: A retrospective chart review of 24 patients (20 women, 4 men, average age 56 years old) with skin types II-V who received 2 or 3 Tixel® treatments, 3-5 weeks apart in two medical centers (12 from Israel, 12 from the United Kingdom). Four experienced dermatologists compared standardized clinical photographs taken before each treatment and 3 months after the final treatment based on seven parameters that were set by 10 physicians and rated the difference on a scale of -1 to 4. Furthermore, epidemiology, treatment data, satisfaction, and safety were reviewed. RESULTS: Out of the seven parameters that were compared (blood vessels and erythema, skin complexion, periorbital wrinkles, pigmentation and toning, pore size, vitality, wrinkles, and laxity), all features demonstrated an overall improvement, with the greatest improvement demonstrated in skin complexion (2.1 ± 0.49) and periorbital wrinkling (2.09 ± 0.65) followed by vitality (1.7 ± 0.49). Side effects were transient, including erythema and hyperpigmentation, and the average downtime was 1.7 days. CONCLUSION: TMFI is a safe and effective method for improving facial skin quality. Addressing patient's expectations while maximizing the benefits of this novel technology will provide superior aesthetical results.

Objective and subjective measurements of cutaneous inflammation after a novel hyaluronic acid injection.

BACKGROUND: Hyaluronic acid (HA) dermal fillers are commonly used to minimize the appearance of facial lines and wrinkles. However, after the injection of HA, there is normally a mild inflammatory reaction. All published studies to date have measured this unwanted side effect by subjective means only. OBJECTIVE: The primary objective was to determine the magnitude and duration of the inflammation induced by injection of a novel HA using objective and subjective means. MATERIALS AND METHODS: The study was an open study in 25 normal volunteer subjects. All subjects had a single injection and were assessed objectively using an erythema meter and infrared thermometer and subjectively using established clinical scales. RESULTS: The erythema meter and the infrared thermometer objectively measured the mild cutaneous inflammation, which was transitory in nature. These objective measurements correlated well with the subjective clinical scores. CONCLUSIONS: The results of this study show that the erythema meter and the infrared thermometer are effective tools to objectively measure mild inflammation post-HA injection.

Different formulations of botulinum toxin type A have different migration characteristics: a double-blind, randomized study.

OBJECTIVE: Different formulations of botulinum toxin type A (BoNTA) are not identical and may behave differently in clinical practice. The reportedly lower incidence of adverse effects with one formulation (from Allergan, Ltd.) relative to another (from Ipsen, Ltd.) may be due to differences in the degree of migration of the neurotoxin-protein complex from its injection site. A double-blind, randomized, within-subject pilot study was performed to compare the migration characteristics of each formulation. METHODS: Twelve healthy volunteers were randomly assigned to receive three 0.1 mL intradermal injections in their forehead: 4 U BoNTA (Allergan) on one side, 12 U BoNTA (Ipsen) on the contralateral side, and saline in the center. At day 14, Minor's iodine starch test was performed, and the subjects walked around a hot room to induce sweating. The appearance of each forehead was documented using Canfield photography and the area of each anhidrotic halo calculated using software. RESULTS: Overall, the area of anhidrosis was significantly larger with BoNTA (Ipsen) than BoNTA (Allergan) - mean +/- SD of 2.7 +/- 0.78 cm(2) vs. 1.8 +/- 0.65 cm(2) (P = 0.005) - with the area of anhidrosis being greater with BoNTA (Ipsen) than BoNTA (Allergan) in 11 of the 12 subjects. Across all subjects, the area of anhidrosis was greater with BoNTA (Ipsen) than BoNTA (Allergan) by a mean of 77%. CONCLUSIONS: BoNTA (Ipsen) migrates more than BoNTA (Allergan) under the conditions described. The lower potential of BoNTA (Allergan) to migrate promotes more precise localization of clinical effects, thereby helping to optimize the risk/benefit ratio.

Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis.

BACKGROUND: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis. OBJECTIVE: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment, a midpotent to potent topical corticosteroid, in the treatment of adult patients with moderate-to-severe atopic dermatitis. METHODS: Patients applied ointment twice daily to all affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve as a percentage of baseline. RESULTS: Five hundred seventy patients were randomized and received treatment. Discontinuations included 22 of 193 patients from the 0.03% tacrolimus group, 22 of 191 patients from the 0.1% tacrolimus group, and 17 of 186 patients from the hydrocortisone butyrate group. The median mEASI mean area under the curve as a percentage of baseline was 47.0%, 36.5%, and 36.1% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 0.1% hydrocortisone butyrate, respectively. There was no statistically significant difference between 0.1% tacrolimus and 0.1% hydrocortisone butyrate; however, the lower improvement in mEASI for 0.03% tacrolimus was statistically significant when compared with 0.1% tacrolimus (P <.001) or hydrocortisone butyrate (P =.002). Skin burning and pruritus at the application site showed a higher incidence in the tacrolimus treatment groups than in the hydrocortisone butyrate group (P <.05). Laboratory parameters showed no treatment differences and no marked changes over time. CONCLUSIONS: The efficacy of 0.1% tacrolimus ointment was similar to that of 0.1% hydrocortisone butyrate ointment and was lower for 0.03% tacrolimus ointment. No serious safety concerns were identified.