Comparative effectiveness of ice packs versus topical lidocaine-prilocaine mixture for pain control in laser hair removal of the axilla: A rater-blinded randomized controlled trial.

BACKGROUND: Laser hair removal is associated with moderate acute pain. OBJECTIVE: To compare effectiveness of ice pack to topical lidocaine-prilocaine for pain reduction during axillary laser hair removal. METHODS: Participants were randomly assigned to receive topical anesthetic to one axilla and ice packs to the other before each of 3, monthly 810 nm diode laser sessions. The primary endpoint was participant-reported pain on the visual analog scale (VAS) immediately following and 5 minutes after laser session. Posttreatment erythema, overall edema, and perifollicular edema were assessed by 2 blinded photoraters. Skin temperatures, patient preferences, and adverse events were recorded. RESULTS: Eighty-eight of 90 (98%) planned laser treatments were delivered and randomized. Participants reported higher VAS scores immediately after laser treatment with lidocaine-prilocaine compared to ice (P = .03). Five minutes after, participants reported higher VAS scores with ice (P = .03). After 53 of the 88 treatments (60.2%), participants reported preferring ice (P = .055). No serious adverse events were reported. LIMITATIONS: All participants were Caucasian or Asian with Fitzpatrick skin type I to III and coarse dark axillary hair, which may limit generalizability. CONCLUSIONS: While pain control with ice and topical anesthesia is associated with time after treatment, the 2 modalities do not differ in terms of degree of pain reduction associated with axillary laser hair removal.

Subcutaneous infiltration of carbon dioxide (carboxytherapy) for abdominal fat reduction: A randomized clinical trial.

BACKGROUND: Noninvasive fat removal is preferred because of decreased downtime and lower perceived risk. It is important to seek new noninvasive fat removal treatments that are both safe and efficacious. OBJECTIVE: To assess the extent to which carboxytherapy, which is the insufflation of carbon dioxide gas into subcutaneous fat, results in reduction of fat volume. METHODS: In this randomized, sham-controlled, split-body study, adults (body mass index, 22-29 kg/m2) were randomized to receive 5 weekly infusions of 1000 cm3 of CO2 to 1 side of the abdomen, and 5 sham treatments to the contralateral side. The primary outcome measures were ultrasound measurement of fat layer thickness and total circumference before and after treatment. RESULTS: A total of 16 participants completed the study. Ultrasound measurement indicated less fat volume on the side treated with carboxytherapy 1 week after the last treatment (P = .011), but the lower fat volume was not maintained at 28 weeks. Total circumference decreased nominally but not significantly at week 5 compared with baseline (P = .0697). Participant body weights did not change over the entire course of the study (P = 1.00). LIMITATIONS: Limitations included modest sample size and some sources of error in the measurement of circumference and fat layer. CONCLUSION: Carboxytherapy provides a transient decrease in subcutaneous fat that may not persist. Treatment is well tolerated.

Utility of a High-Resolution Superficial Diagnostic Ultrasound System for Assessing Skin Thickness: A Cross-Sectional Study.

BACKGROUND: Compared with other imaging modalities, ultrasound is relatively deeply penetrating and can be used to evaluate deep dermal and subcutaneous structures. OBJECTIVE: Image skin thickness of the face and neck using high-frequency diagnostic ultrasound devices. MATERIALS AND METHODS: Skin overlying 20 different predesignated face and neck anatomic sites in 32 individuals was imaged using 2 commercially available high-frequency diagnostic ultrasound devices, a dedicated imaging device and a diagnostic device bundled with a therapeutic device. At each site, the subcutaneous and combined epidermal and dermal layer thicknesses were assessed by blinded expert raters. RESULTS: Similar skin thickness measurements were obtained. Notably, subcutaneous fat depth was measured to be 0.2 cm at the forehead; 0.5 cm at the mental eminence; and 0.6 cm at the submental, supraglenoid, and temporal regions. The combined epidermal and dermal thickness was approximately 0.1 cm at the zygomatic process, suborbital area, inferior malar region, gonion, supraglenoid area, and nasolabial-buccal, and nasolabial fold regions. CONCLUSION: This is the first study using high-resolution superficial diagnostic ultrasound to map skin thickness of the face and neck at standard anatomic locations. Ultrasound is an inexpensive, noninvasive, and convenient means to monitor dermatologic conditions and guide their treatment.

Safety of Local Intracutaneous Lidocaine Anesthesia Used by Dermatologic Surgeons for Skin Cancer Excision and Postcancer Reconstruction: Quantification of Standard Injection Volumes and Adverse Event Rates.

BACKGROUND: Intracutaneous lidocaine is used for anesthesia in dermatologic surgery for skin cancer excision and repair with exceedingly low incidence of reported adverse events. OBJECTIVE: To measure (1) the quantity of lidocaine typically used for facial skin cancer excision and reconstruction; and (2) the frequency and character of associated adverse events. METHODS: Survey study of dermatologic surgeons with longitudinal reporting. Reported practice during 10 business days: (1) mean volume of 1% lidocaine per skin cancer excision; (2) maximum per excision; (3) mean per reconstruction; and (4) maximum per reconstruction. RESULTS: A total of 437 of 1,175 subjects contacted (37.2%) responded. Mean per excision was 3.44 mL (SD: 2.97), and reconstruction 11.70 mL (10.14). Maximum per excision was 6.54 mL (4.23), and reconstruction was 15.85 mL (10.39). No cases of lidocaine toxicity were reported, diagnosed, or treated. Incidence of adverse events possibly anesthesia related was >0.15%, with most (0.13%) being mild cases of dizziness, drowsiness, or lightheadedness from epinephrine tachycardia. CONCLUSION: Toxicity associated with local anesthesia other than lidocaine was not studied. Volumes of lidocaine in skin cancer excision and repair are modest and within safe limits. Lidocaine toxicity is exceedingly rare to entirely absent. For comparable indications, lidocaine is safer than conscious sedation or general anesthesia.

Subcision with and without suction for acne scars: a split-faced, rater-blinded randomized control trial.

Therapeutic options for acne scars include subcision and suction with microdermabrasion, but these treatment modalities have not been studied in conjunction. To compare effectiveness of subcision alone versus subcision with suction for the treatment of facial acne scars. Randomized, split-faced, evaluator-blinded control trial. Participants underwent one subcision treatment on both sides of the face followed by 10 sessions of suction to one side. Photographs at baseline, 1-month, and 4-months were assessed. Primary outcome measures were the validated Acne Scar Severity Scale (ASSS) (0 = no acne scarring, 4 = severe), Acne Scar Improvement Grading Scale (ASIGS) (-100 to 100%), and modified Quantitative Global Scarring Grades (QGSG) (point-based questionnaire instrument), as well as subject preference. Twenty-eight treatment areas and 154 treatments were analyzed. Dermatologist raters found no differences between subcision alone and subcision-suction at 1-month or 4-months. Mean subject-assessed percent improvement for subcision-suction was higher than that for subcision alone at 1-month (37% versus 24%, p = 0.04) but not at 4-months (p = 0.37). Subjects preferred combination therapy to monotherapy at 1-month (50% vs. 21%) and 4-months (43% vs. 21%). While blinded raters did not detect significant differences, subjects perceived combination treatment as working more quickly than monotherapy, and preferred combination treatment at all time points.Clinical trial registration NCT01696513 on Clinicaltrials.gov.

Effectiveness of Low Doses of Hyaluronidase to Remove Hyaluronic Acid Filler Nodules: A Randomized Clinical Trial.

Importance: Although hyaluronidase is known to remove hyaluronic acid fillers, use of low doses has not been well studied. Objective: To assess the effectiveness and dose-related effect of small quantities of hyaluronidase to treat hyaluronic acid filler nodules. Design, Setting, and Participants: Split-arm, parallel-group, randomized clinical trial at an urban academic center. Participants were 9 healthy women. Recruitment and follow-up occurred from February 2013 to March 2014; data analysis occurred from February to July 2016. Interventions: Each participant received aliquots (buttons) of either of 2 types of hyaluronic acid fillers into bilateral upper inner arms, respectively. At 1, 2, and 3 weeks each button was treated with a constant volume (0.1 mL) of variable-dose hyaluronidase (1.5, 3.0, or 9.0 U per 0.1 mL) or saline control. Main Outcomes and Measures: Both a blinded dermatologist and the participant independently assessed detectability. Results: Seventy-two treatment sites on 9 women (mean [SD] age, 45.8 [15.7] years) received all interventions and were analyzed. There was a significant difference in physician rater assessment between saline and hyaluronidase at 4 weeks (visual detection: mean difference = 1.15; 95% CI, 0.46-1.80; P < .001; palpability: mean difference = 1.22; 95% CI, 0.61-1.83; P < .001) and 4 months (visual detection: mean difference = 0.77; 95% CI, 0.33-1.26; P = .001; palpability: mean difference = 0.82; 95% CI, 0.38-1.25; P < .001) that was mirrored by participant self-assessment at 4 weeks (visual detection: mean difference = 0.87; 95% CI, 0.26-1.48; P = .006; palpability: mean difference = 1.59; 95% CI, 1.41-1.77; P < .001) and 4 months (visual detection: mean difference = 1.31; 95% CI, 1.09-1.53; P < .001; palpability: mean difference = 1.52; 95% CI, 1.03-2.01; P < .001), and hyaluronidase was associated with greater resolution of buttons compared with normal saline. The 9.0-unit hyaluronidase injection sites were significantly less palpable than the 1.5-unit sites at both 4 weeks (mean difference = 0.50; 95% CI, 0.01-.99; P = .045) and 4 months (mean difference = 0.47; 95% CI, 0.14-0.81; P = .007). Dose dependence was more notable for Restylane-L. Conclusions and Relevance: Although very small doses of hyaluronidase can remove hyaluronic acid fillers from patient skin, slightly higher doses often result in more rapid resolution. Trial Registration: clinicaltrials.gov Identifier: NCT01722916.

Effect of Platelet-Rich Plasma Injection for Rejuvenation of Photoaged Facial Skin: A Randomized Clinical Trial.

Importance: There remains little experimental evidence and no randomized clinical trial to date to confirm the benefit of platelet-rich plasma (PRP) for facial rejuvenation. Objective: To investigate whether PRP injection improves the visual appearance, including texture and color, of photodamaged facial skin. Design, Setting, and Participants: In this randomized clinical trial, participants and raters were masked to groupings. The setting was an academic-based, urban outpatient dermatology practice in Chicago, Illinois. Participants were adults aged 18 to 70 years with bilateral cheek rhytids of Glogau class II or greater. The duration of the study was August 21, 2012, to February 16, 2016. Interventions: Each participant received 3 mL intradermal injections of PRP to one cheek and sterile normal saline to the contralateral cheek. Main Outcomes and Measures: Primary outcomes were photoaging scores (with subscores for fine lines, mottled pigmentation, roughness, and sallowness) as rated by 2 masked dermatologists. Secondary outcomes included participant self-assessment scores of improvement on a 5-point scale (worsening, no change, mild improvement, moderate improvement, or significant improvement), participant overall satisfaction scores on a 4-point scale (not satisfied, slightly satisfied, moderately satisfied, or very satisfied), and participant-reported or investigator-observed adverse events. Results: Of 27 enrolled participants, 19 (mean [SD] age, 46.37 [10.88] years; 17 female) were analyzed. Reported adverse events, which were not associated with the study agent, included redness (n = 18), swelling (n = 16), bruising (n = 14), pruritus (n = 1), skin scaling (n = 1), and dryness of skin (n = 1). No participants reported any adverse events at 12 months. Mean (SD) photoaging scores rated by 2 dermatologists showed no significant difference between PRP and normal saline for fine lines (baseline, 1.00 [0.75] vs 1.05 [0.78]; 2 weeks, 0.95 [0.71] vs 0.95 [0.71]; 3 months, 0.95 [0.71] vs 0.95 [0.71]; 6 months, 0.95 [0.71] vs 0.95 [0.71]), mottled pigmentation (baseline, 1.21 [0.53] vs 1.21 [0.54]; 2 weeks, 1.16 [0.60] vs 1.16 [0.60]; 3 months, 1.00 [0.47] vs 1.11 [0.46]; 6 months, 1.16 [0.69] vs 1.16 [0.69]), skin roughness (baseline, 0.47 [0.61] vs 0.47 [0.61]; 2 weeks, 0.47 [0.61] vs 0.47 [0.61]; 3 months, 0.47 [0.61] vs 0.47 [0.61]; 6 months, 0.37 [0.60] vs 0.37 [0.68]), and skin sallowness (baseline, 1.11 [0.88] vs 1.11 [0.88]; 2 weeks, 0.95 [0.85] vs 0.95 [0.85]; 3 months, 0.58 [0.61] vs 0.58 [0.61]; 6 months, 0.37 [0.68] vs 0.37 [0.68]). At 6 months after a single treatment, participants rated the PRP-treated side as significantly more improved compared with normal saline for texture (mean [SD] self-assessment score, 2.00 [1.20] vs 1.21 [0.54]; P = .02) and wrinkles (mean [SD] self-assessment score, 1.74 [0.99] vs 1.21 [0.54]; P = .03). Conclusions and Relevance: Masked participants noted that both fine and coarse texture improved significantly more with a single treatment of PRP than with normal saline. Both participants and raters found PRP to be nominally but not significantly superior to normal saline. Trial Registration: ClinicalTrials.gov Identifier: NCT01372566.

Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections: A Randomized Clinical Trial.

IMPORTANCE: Transcutaneous injection through smaller hollow-bore needles may decrease patient discomfort, but current evidence is equivocal. OBJECTIVE: To compare injection discomfort in patients treated with botulinum toxin type A with 30- and 32-gauge needles. DESIGN, SETTING, AND PARTICIPANTS: Split-face, patient- and injector-blinded randomized clinical trial at the dermatology service of an urban university medical center. The 20 participants were women aged 25 to 70 years in good health and with moderate dynamic forehead and glabellar wrinkles. Data were collected from November 20, 2013, through January 16, 2014. Follow-up was complete on January 16, 2014. Data from the per-protocol population were analyzed from July 1 to July 31, 2014. INTERVENTIONS: One side of each patient'sforehead received botulinum toxin type A in saline injected with a 32-gauge needle; the other side received the same treatment injected with a 30-gauge needle. In addition, each patient received randomized injections of saline only to both upper inner arms with the same types of needles. MAIN OUTCOMES AND MEASURES: Primary outcomes included the patient-reported pain rating on a visual analog scale (VAS) on either side of the face and arms and the proportion of patients whose VAS ratings corresponded with more than moderate (ie, clinically significant) pain. The secondary outcome consisted of patient-reported information about the character of the pain at both sites using the expanded and revised version of the Short-Form McGill Pain Questionnaire. RESULTS: All 20 patients completed the study. Overall, facial and arm injections were nominally but not significantly more painful with 30-gauge needles (mean [SD] VAS ratings for the face, 4.16 [2.55] vs 3.41 [2.31], P = .34; for the arm, 1.66 [2.07] vs 1.21 [1.65], P = .45). For facial injections, the likelihood of clinically significant pain (VAS rating, ≥5.4) was significantly greater with 30-gauge needles, which were associated with such pain in 8 patients (40%) compared with the 32-gauge needles, which were associated with such pain in 3 patients (15%) (odds ratio, 3.80 [95% CI, 1.05-13.78]; P = .04). No difference was found in the character of pain associated with needle bore (P > .05 for all comparisons). CONCLUSIONS AND RELEVANCE: For facial injections of neurotoxin in saline, 30-gauge needles were associated with greater incidence of clinically significant pain than 32-gauge needles. For patients prone to experience clinically significant pain with facial injections, use of 32-gauge needles may minimize this discomfort. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01981174.

Multifunctional skin-like electronics for quantitative, clinical monitoring of cutaneous wound healing.

Non-invasive, biomedical devices have the potential to provide important, quantitative data for the assessment of skin diseases and wound healing. Traditional methods either rely on qualitative visual and tactile judgments of a professional and/or data obtained using instrumentation with forms that do not readily allow intimate integration with sensitive skin near a wound site. Here, an electronic sensor platform that can softly and reversibly laminate perilesionally at wounds to provide highly accurate, quantitative data of relevance to the management of surgical wound healing is reported. Clinical studies on patients using thermal sensors and actuators in fractal layouts provide precise time-dependent mapping of temperature and thermal conductivity of the skin near the wounds. Analytical and simulation results establish the fundamentals of the sensing modalities, the mechanics of the system, and strategies for optimized design. The use of this type of "epidermal" electronics system in a realistic clinical setting with human subjects establishes a set of practical procedures in disinfection, reuse, and protocols for quantitative measurement. The results have the potential to address important unmet needs in chronic wound management.