Impact of microwave thermolysis energy levels on patient-reported outcomes for axillary hyperhidrosis and osmidrosis.

OBJECTIVE: Microwave thermolysis (MWT) is an emerging treatment for axillary hyperhidrosis reducing both sweat and odor. No prior studies have investigated and compared the different available energy settings of the MWT device. This study evaluated patient-reported outcome measures (PROMs) for axillary hyperhidrosis and osmidrosis following MWT treatment with two different energy levels. METHODS: Twenty adults with axillary hyperhidrosis and osmidrosis reported sweat on Hyperhidrosis Disease Severity scale (HDSS: 1-4) and odor on Odor scale (OS: 1-10), respectively, supplemented by overall Dermatology Life Quality Index (DLQI: 0-30). This was a prospective, randomized, patient-blinded and intraindividually controlled study with 3 months follow-up (FU). Randomization comprised MWT treatment of one axilla with a standard medium energy setting (energy level 3) and the contralateral axilla with a standard high energy setting (energy level 5). RESULTS: At baseline, patients reported substantial sweat and odor, negatively affecting their quality of life. At 3 months FU, PROMs showed improved quality of life with significantly reduced odor and sweat. Overall DLQI was reduced from a median of 10 to 4, with a median 6.5-point reduction (p = 0.0002). HDSS was reduced from a median of 4 to 2 on both sides, with a median reduction of 1 for medium energy level and 2 points for high energy level (p = 0.014). OS was reduced from a median of 8 to 3 for both energy levels, with a median reduction of 3.5 and 4.5 points for the medium and high energy level, respectively (p = 0.017). Local skin reactions were mild and transient, but slightly more pronounced following treatment with the high energy level. CONCLUSION: MWT effectively improved patients' quality of life, axillary sweat, and odor 3 months after on baseline treatment. Treatment with the high energy level presented a subtle but significant increase of efficacy based on PROMs for both sweat and odor. Patients were willing to accept a higher amount of temporary local skin reactions from a higher energy setting when experiencing greater odor and sweat reduction.

An RCT on the effects of topical CGP on surgical wound appearance and residual scarring in bilateral total-knee arthroplasty patients.

OBJECTIVE: To test the hypothesis that topically applied calcium glycerophosphate (CGP) would improve the appearance of the wound following bilateral knee replacement. METHOD: Healthy patients, aged 45-75 years, scheduled for bilateral total-knee replacement surgery were recruited into the study. One knee was randomly assigned to the treatment group, while the contralateral knee was designated the control (standard care). Subjects were instructed to apply a preparation of 10% CGP in an aqueous lotion to the treated knee once daily for 42 days, starting at the third postoperative day. Functional sealing and cosmetic appearance of the incision were evaluated by two surgeons by direct examination of the patient and then by two experienced assessors from photographs. The investigators qualitatively scored the intensity and extent of erythema along the incision and over the entire knee, the appearance of visible oedema along the incision and over the knee, and the overall clinical impression of wound healing. All four assessors were blinded to the subjects' allocation and the latter two assessors to the initial investigators' assessments. Subjects were also followed up for an additional 46 weeks, giving a total study duration of 12 months. RESULTS: Twenty patients completed the study. Statistical analysis showed that both the area and intensity of erythema along the incision were significantly reduced in the treated vs untreated knee over the entire study period. The analysis further showed that treatment significantly reduced oedema, both along the incision and across the entire knee. The differences were most marked at the seventh postoperative day and diminished with time. No adverse effects were observed for any patient, in either treated or untreated knees. CONCLUSION: These data demonstrate that postoperative application of 10% CGP could improve the appearance of the wound following total knee arthroplasty.

Scrotal temperatures do not differ among young boys wearing disposable or reusable diapers.

BACKGROUND/AIMS: This study investigated the effect of specific, commonly used diaper types on scrotal temperatures in normal healthy, young boys. These included both modern disposable and reusable diapers as well as various types of protective outer coverings that are in common use in both North America and Europe METHODS: Scrotal and skin surface temperatures were continuously monitored in healthy, young males using a computerized data-logging system based on temperature probes specifically designed for paediatric studies. These systems could be used either tethered to the PC or made completely portable depending upon the age and activity of the child being measured. Based on our results from several pilot studies, it became clear that the best way to determine if disposable and reusable diapers differ with regard to their impact on scrotal temperatures is to run these comparisons under controlled laboratory conditions where "diaper type" was the primary variable. A 2-h time period was chosen to ensure that sufficient time had elapsed for thermal equilibrium to be established under the diapers. We also felt it necessary to study the impact of urination and simulated this condition over the last 15 min using standardized methods. In addition to the skin surface temperatures, we also measured the temperature of the tympanic membrane using an infrared thermometer as an estimate of "core" temperature for each individual at various times during the session. RESULTS AND CONCLUSIONS: In this study, we have clearly shown that scrotal temperatures are the same whether the child is wearing disposable or reusable cloth diapers with a protective cover. The only situation in which scrotal temperatures were found to be lower is when the cloth diaper is used alone without a protective cover but this is not representative of how these products are actually used. We also found that on average scrotal temperatures are significantly lower than core for each diaper type. Occasionally, we did see individuals in which the maximal scrotal temperatures approached core temperatures but in every case the thermal sensors were soiled by a bowel movement. We also found that skin surface temperatures increased not only when covered by a diaper but also due to the thermal insulation provided by outer garments and blankets.

Methods for evaluating changes in skin condition due to the effects of antimicrobial hand cleansers: two studies comparing a new waterless chlorhexidine gluconate/ethanol-emollient antiseptic preparation with a conventional water-applied product.

BACKGROUND: Hand-cleansing products that are milder to the skin of health care personnel are being developed, but the available methodologies to appropriately evaluate these products and quantify differences are not generally being applied in well-controlled studies. METHODS: Two randomized, blinded, bilateral comparison studies evaluated skin condition during use of 2 antiseptic hand preparation products: a new 1% chlorhexidine gluconate (CHG)/61% wt/wt ethanol antiseptic hand preparation in a unique emollient system for waterless/brushless application and a conventional 4% CHG antimicrobial product that is applied with water and a scrub brush. Trained technicians applied treatments 6 times (for a surgical scrub study) or 24 times (for a personnel handwash study) daily to the hands of healthy volunteers during 5 days of controlled washing. An expert grader evaluated skin for dryness, erythema, and roughness. Subjects completed a self-assessment questionnaire on skin condition. Transepidermal water loss was measured by an evaporimeter, and the skin surface hydration level was measured by an electrical conductance meter. RESULTS: Fifty-eight subjects were enrolled in the 2 studies and received both treatments. In general, skin treated with the waterless CHG/ethanol product scored significantly (P <.004) better on evaluations of visual dryness and erythema and showed greater improvement in the level of hydration (P <.003). In the health care personnel handwash study, transepidermal water loss was less than that for skin treated with the conventional CHG product (P <.002). Subject assessments showed similar results (total score, P <.007). CONCLUSIONS: All 3 approaches of expert grader evaluation, subject assessment, and instrumentation were in concordance, demonstrating that the waterless CHG/ethanol product was gentler to skin than the conventional CHG product.

Randomized facial tolerability studies comparing gel formulations of retinoids used to treat acne vulgaris.

Two double-blind, randomized, split-face studies have been performed to compare the facial tolerability of topical retinoids in volunteers with sensitive skin. In one study, subjects applied tazarotene 0.1% gel to one side of their face and tretinoin 0.1% gel microsponge, tretinoin 0.025% gel, or adapalene 0.1% gel to the other side of their face, for up to 29 days. Increases in facial dryness and erythema were comparable among all retinoids. Some subjects in each treatment group experienced levels of retinoid-associated irritation that required temporary suspension of, or reduction in, treatment. Facial dryness and erythema tended to be greater in these subjects than in those who tolerated the regimen without change, suggesting that the need to discontinue or modify treatment depends more on the individual than on any major inherent differences in the irritant potential of these retinoids. A second study compared once-daily versus alternate-day tazarotene 0.1% gel therapy. Tolerability was superior when initiating therapy with the alternate-day regimen.

A pilot study of noninvasive methods to assess healed acute and chronic wounds.

BACKGROUND: A variety of instruments are available that can objectively assess physical parameters of the skin such as strength, firmness, elasticity, hydration, and color, often undetected by clinical assessment. OBJECTIVE: To assess the physical properties of healed acute and chronic wounds using several noninvasive instruments. METHODS: Four patients with healed acute wounds and four patients with healed chronic wounds were studied using ballistometric, impedance, levarometric, and spectrophotometric measurements. RESULTS: In general, scars were harder, less elastic, dryer, and more erythematous than control skin. These differences were more pronounced in healed chronic wounds. CONCLUSION: A scar from an acute surgical wound becomes softer, more elastic, dryer, less erythematous, and less pigmented as it ages. In contrast, chronic wound scars become harder as they age. These different properties of healed acute wounds and healed chronic wounds may be a result of the different healing processes in each wound type.

A hand immersion test under laboratory-controlled usage conditions: the need for sensitive and controlled assessment methods.

Exaggerated test conditions were frequently used to investigate the cutaneous tolerance of detergent products in the past. As the sensitivity of newly designed biometric methods is steadily improving, the trend towards more realistic test conditions should be encouraged. A hand immersion test under laboratory-controlled usage conditions is presently described, fulfilling such principles. Panelists soaked their hands in 2 different hand dishwashing liquids, 2x daily for 10 min each (with successive in-solution/out-of-solution cycles) for 4 consecutive days. Products were at usual dilution for dishwashing liquids and were randomized between the dominant and non-dominant hands of panelists. Visual scoring of erythema and dryness developing on the whole hands (scoring scales including interdigital areas and joints) during the week did not allow discrimination between the 2 products. However the dominant hands were significantly more susceptible to alterations than the non-dominant hands, regardless of product attribution. In contrast, skin electrical measurements (Corneometer CM800 and Skicon 200) on the dorsum of the hands (muscle mass between thumb and index) and squamometry analysis of tape stripping (harvested from the same site) yielded significant differences between the 2 products. In conclusion, a hand immersion test under realistic conditions has been described, which discriminates between products when sensitive assessment methods are used to explore skin sites partially protected from daily-life skin aggressions.

A refined method to evaluate diapers for effectiveness in reducing skin hydration using the adult forearm.

BACKGROUND/AIMS: Excessive skin hydration resulting from wet undergarments is a major cause of diaper rash in children and contributes to severe dermatitis in incontinent adults. Advancements in absorbent technology have led to diapers and incontinent garments that not only absorb urine, but also transfer it to different regions, and lock it away from the skin. The purpose of the present study was to develop a reliable method to assess the effectiveness of absorbent articles in mitigating skin hydration. METHODS: Disposable diapers with different absorbent structures were wrapped around the forearms of adult volunteers, loaded with urine substitute, and held in place for 1 h. Hydration of the volar region was measured by evaporimetry and compared with that of skin in the diaper region of children who had worn control loaded diapers in the usual way. The amount of fluid retained in various diaper layers and in the superabsorbent polymer core was measured. CONCLUSIONS: Evaporative water loss measurement on adult forearms was shown to be a reliable test for comparing the effectiveness of absorbent articles in preventing excessive skin hydration provided that 1) the complete garment was used and 2) fluid was loaded in a manner that simulated normal urination. Skin on adult forearms and skin in the diaper region of children were concordant in their response to wet diapers. Skin wetness was directly related to the amount of liquid retained in absorbent layers close to the skin.

Clinical and histological effects of glycolic acid at different concentrations and pH levels.

BACKGROUND: Much has been said about the effects of glycolic acid with little scientific evidence to substantiate the findings. OBJECTIVE. This study reports on the clinical and histological effects of glycolic acid at pH levels 3.25, 3.80, and 4.40, and at 3.25%, 6.50%, 9.75%, and 13.00% on ichthyotic/xerotic skin. METHODS: Product treatment consisted of a 2-week washout period followed by 3 weeks of product application (BID) with A 1-week regression period. Shave biopsies and clinical evaluations for dryness, moisturization, and transepidermal water loss were made at baseline, 1, 2, and 3 weeks of use, and at the regression period. RESULTS: Clinically, ichthyotic/xerotic skin was normalized with histologic evidence of stratum corneum thinning, viable epidermal thickening, and marked increases in glycosaminoglycan and collagen content. CONCLUSION: All pH levels and concentrations demonstrated significant improvement in the condition of the skin with trends implying that increasing the pH increases efficacy.

Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation.

BACKGROUND: Epidemiologic studies indicate that after using soaps and other personal care products, many consumers experience irritation. In 50% of the cases the feelings of skin dryness, itching, and stinging occur in the absence of visible signs of irritation. OBJECTIVE: We sought to determine the relation between self-perceived sensory responses of panelists to cleansing products and clinical signs of irritation. METHODS: A combination of exaggerated arm-washing methods was designed to induce clinical signs of irritation with psychometric techniques developed to quantify sensations. RESULTS: Two studies demonstrated that panelists could reproducibly differentiate between products on the basis of the sensations they felt and that there was a significant correlation (frequently r > 0.80) between these and the observable signs. In the case of skin dryness panelists differentiated products several washing cycles before observable differences were detected. CONCLUSION: Sensory evaluations of irritation yield additional information on soap and detergent irritancy beyond clinical observations and expand understanding of the irritation process.

Evidence for accelerated skin wrinkling among developmentally delayed individuals with Down's syndrome.

Down's Syndrome (DS) is a genetic disorder involving mental retardation which is reported to be a condition of accelerated aging. However, few studies exist which examine age-dependent changes in DS and these studies fail to include a control group. In the present study a non-invasive, painless, and easily obtainable measure reflecting age-dependent topographical changes of the skin (skin wrinkling) was obtained in 15 DS subjects, 14 developmentally disabled (DD) (mentally retarded) controls (DD controls) and 16 healthy controls of similar ages ranging from 22 to 51 years. The healthy control group failed to show correlations of skin measures with age, as predicted for the age-range of these subjects, based on results of previous studies. However, the DS group showed significant correlations of all skin measures from relatively non-sun-exposed and sun-exposed skin sites, with age. The DD control also showed significant correlations with age of several but not all skin sites and the correlation coefficients tended to be less than that of the DS; at least, when contrasted with the healthy controls the DS showed greater values of several skin measures suggestive of accelerated skin wrinkling. These results provide evidence for accelerated aging of the skin, and possibly greater effects of sun-exposure on skin wrinkling, in DS and possibly (DD) individuals in contrast to healthy individuals without a genetic disorder and without mental retardation.

Alteration of argon laser-induced scars by the pulsed dye laser.

Ten patients with portwine stains (PWS) with test sites previously exposed to an argon laser were evaluated and subsequently treated with five pulsed dye (585 nm) laser treatments over a 10 month period. Clinical assessments, skin surface texture analyses using optical profilometry, and light microscopic histological evaluations were performed prior to commencement and at the end of the study in all ten patients. A change in the skin texture with return of skin markings approximating those of normal skin measured by optical profilometry was observed in the argon treated PWS skin following pulsed dye laser treatments.

Sequential order of skin responses to surfactants during a soap chamber test.

Differences in the response of distinct layers of the skin to surfactants were probed using a modification of the Frosch and Kligman soap chamber test. Soap and other surfactant-containing cleansers were applied to the skin for 2 consecutive days. Transepidermal water loss showed that the stratum corneum is readily damaged even by a mild insult when no erythema is induced. A more severe treatment, such as 24-h exposure to a 5% soap solution, induced the maximal level of barrier damage but a submaximal level of erythema. Even 2 days of exposure to 5% soap does not elicit a maximal erythema response. These results suggest that the stratum corneum is more readily damaged than the dermis, which is not unexpected because the stratum corneum is the initial point of contact between surfactant and skin. Furthermore, this study indicates that for discriminating among mild products, when a small degree of irritation is induced, the most effective measure is stratum corneum damage assessed by evaporimetry. However, for evaluating more irritating products, erythema is probably the more discriminating evaluation technique.

Skin replica analysis of photodamaged skin after therapy with tretinoin emollient cream.

Computerized image analysis of silicone replicas, a reproducible, objective technique for measuring skin topography, was used in addition to clinical measures in two multicenter, double-blind, randomized, controlled studies of tretinoin emollient cream, a new formulation for treating photodamaged skin. Previously, the skin replica technique had been successfully used in a pilot study of tretinoin 0.05% cream by one investigator. In the present studies, subjects treated for 24 weeks with tretinoin emollient 0.05% cream consistently showed more improvement in skin topography than did vehicle-treated patients. A 0.01% concentration of tretinoin emollient cream also improved skin topography to a greater extent than the vehicle, while the lowest concentration tested (0.001%) showed little difference from vehicle. These results, reflecting a smoothening of the skin surface in tretinoin emollient cream-treated subjects, were consistent with clinical data showing greater improvement in fine wrinkling and roughness after tretinoin emollient cream therapy than after vehicle therapy. Findings from these multicenter studies confirm the value of the skin replica technique and help establish the efficacy of tretinoin emollient 0.05% cream for photodamaged skin.

Computerized image analysis of full-hand touch plates: a method for quantification of surface bacteria on hands and the effect of antimicrobial agents.

A method is described for quantification of the bacterial flora on the hand surface. Computer-assisted image analysis of bacterial growth of large full-hand touch plates provides a quantifiable measure of the bacterial flora on the hand surface. Image analysis pixel intensity values showed a significant correlation (P less than 0.0001) with colony forming unit values determined by the glove juice method. Image analysis of impressions from hands treated with various antimicrobial agents in detergent bases showed that 4% chlorhexidine gluconate produces a 96% reduction after a 30 s washing and 98% reduction after a 3 min washing while 7.5% povidone-iodine and 1% triclosan produce a 77% and 70% reduction after 3 min respectively, and 70% isopropanol produces a 98% reduction after a 30 s wash.

Optical profilometry: an objective method for quantification of facial wrinkles.

Facial fine lines and wrinkles can be faithfully captured by silicone rubber impression materials. Computerized digital image processing of such specimens provides objective measurement of the skin's topography, which has a significant degree of correlation with clinical grading. Optical profilometry provides a dimension of objectivity that can complement clinical assessment in the study of agents that may be useful in the therapy of photodamaged skin.