Skin Protectants Made of Curable Polymers: Effect of Application on Local Skin Temperature.

Objective: To measure the skin temperature after application of a new skin protectant intended for incontinence-associated dermatitis (IAD), compared with a commercial product with an analogous cyanoacrylate-based chemistry. Approach: Twelve healthy human volunteers received an application of the new product on one thigh and of the comparator on the other thigh. An infrared camera using ThermaCAM™ software imaged the skin and measured the temperature at the skin surface over time to characterize the thermal cure profile induced by the products on the skin. Results: The new product led to a drop in skin surface temperature (endothermic reaction), whereas the commercial product displayed an exotherm and a slight rise in skin surface temperature. Innovation: Cyanoacrylate-based chemistries come in various formulations, differing in the side chains and additives used. They are liquid monomers that polymerize after application, and this polymerization is accompanied by an exothermic reaction that can be perceived as an unpleasant warming sensation, especially on compromised skin. A new formulation was designed to mitigate this rise in temperature. Conclusion: The new skin protectant may potentially be more comfortable for IAD patients, since it causes a drop in skin surface temperature instead of a rise during the curing process that follows application.

Clinical Evaluation of a Skin Protectant for the Management of Incontinence-Associated Dermatitis: An Open-Label, Nonrandomized, Prospective Study.

PURPOSE: The purpose of this study was to evaluate the efficacy of an investigational skin protectant product at managing severe skin breakdown associated with incontinence. DESIGN: Open-label, nonrandomized, prospective study. SUBJECTS AND SETTING: The sample comprised 16 patients; inclusion criteria were: patients older than 18 years, cared for in the intensive care unit of a level I trauma center hospital or in long-term care facilities in the northeast region of the United States, and had incontinence-associated dermatitis (IAD). Twelve of the patients had epidermal skin loss and 4 had severe redness. METHODS: The investigational product is a formulation based on acrylate chemistry. The skin protectant application schedule was twice weekly for up to 3 weeks for a maximum of 6 applications during the study period. The skin was evaluated via a skin assessment instrument specifically designed for use in this study; this instrument has not undergone validation studies. The main outcome measure was changes in the instrument score over time. In addition, complete reepithelialization was recorded when observed, and pain scores (associated with IAD) were noted in participants who were able to report pain. RESULTS: The IAD score improved in 13 of 16 patients, remained unchanged in 1 patient, and deteriorated in 2 patients. The median percent improvement in the skin assessment instrument was 96% (P = .013). Four of the patients with epidermal skin loss had complete reepithelialization of the skin surface with 4 to 6 applications of the skin protectant, and 5 had substantial improvement. The 4 patients with severe red skin returned to healthy normal skin with 2 to 4 skin protectant applications. Substantial pain reduction was reported by all 9 patients who reported pain at enrollment. No adverse events associated with the skin protectant application were reported during data collection. CONCLUSION: Results of this study suggest that an acrylate-based product, evaluated here for the first time in patients, may be effective as a protective barrier in the presence of continued incontinence. Additional research is needed to confirm these findings.

In vivo methods to evaluate a new skin protectant for loss of skin integrity.

A new skin protectant was developed for use on conditions involving partial-thickness skin loss such as severe incontinence-associated dermatitis. This new formulation is based on a cyanoacrylate chemistry designed to polymerize in situ and create a breathable film able to protect the skin surface from external irritants. This film provides an environment favorable for healing to occur beneath the film. To evaluate the characteristics of the novel chemistry, we devised a preclinical testing strategy comprising three different animal models. The data from all three models was considered collectively to create an overall assessment of effectiveness. A guinea pig model was used to evaluate the barrier efficacy of the new product in protecting intact skin from irritation. A porcine partial-thickness wound model was used to evaluate the efficacy of the product in helping control minor bleeding and exudate. A similar model was also used to assess the process of reepithelialization in the continued presence of an irritant. In the first model, untreated sites had 8.5 times more irritation than sites covered with the new product (p < 0.001). In the second model, a single application of the new product successfully attached to intact peri-wound skin and to denuded, weepy skin. It significantly reduced the amount of fluid weeping from the wounds (p ≤ 0.001) and continued to perform throughout a 96 hours experiment. In the third model, the percent of reepithelialization was significantly greater for the wounds covered with the new product than for the control wounds (p = 0.003; on average, 18.3% greater, with a 95% confidence interval of 9.2% to 27.5%). These results suggest that the new skin protectant protects intact and denuded skin from irritants and provides an environment favorable to healing, offering promise for the management of various conditions involving loss of epidermis.

Reducing Friction on Skin at Risk: The Use of 3M™ Cavilon™ No Sting Barrier Film.

Objective: To compare the coefficient of friction (CoF) of skin against fabric when the skin is covered with a liquid barrier film versus a silicone dressing, relative to a bare skin baseline. Approach: A laboratory instrument allowing the measurement of friction between two surfaces was used to compare the CoF between a fabric representing bed linen (100% cotton) and the skin of two laboratory operators, either bare (dry or hydrated) or covered with a liquid barrier film or a silicone dressing. Results: The CoF of hydrated skin was over twice the value found for dry skin. The liquid barrier film product reduced the CoF of hydrated skin to a greater extent than the silicone dressing. Innovation and Conclusion: Silicone dressings have recently been promoted to help prevent pressure ulcers. Published data have shown that their CoF is lower than other dressings, but the data were not compared to bare skin. We found that a liquid barrier film provided a greater reduction in the CoF of skin against linen than a silicone dressing. In the context of preventative use (e.g., application on intact skin) to reduce the risk of pressure ulcers, applying a liquid barrier film may reduce friction better than a silicone dressing.

Randomized comparison of a silicone tape and a paper tape for gentleness in healthy children.

PURPOSE: To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children. DESIGN: A randomized, grader-blinded, comparative study. SUBJECTS AND SETTING: The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age (mean ± SEM, 34.0 ± 2.21). The study was conducted at a dermatological research facility (cyberDERM, Inc) located in Broomall, Pennsylvania. All volunteers were recruited from the surrounding community. METHODS: Tapes measuring 1 × 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back. Tapes were removed in a standardized fashion after 24 hours. The primary study outcome, gentleness, was based on visual assessments of skin damage, discomfort, and quantification of keratin removal. Four-point scales were used to assess skin damage, and a 10-point Faces, Legs, Activity, Cry, and Consolability instrument was used to assess discomfort. Secondary assessments included hair removal, tape edge-lift assessments, and parent preference for either tape. RESULTS: There was a significantly lower mean ± SEM erythema response for the silicone tape (0.93 ± 0.14 vs 1.35 ± 0.11, P = .0129) than for the paper tape. No measurable epidermal stripping occurred with the silicone tape compared to a mean ± SEM response of 0.29 ± 0.11 for the paper tape (P = .0039). Discomfort was significantly lower (P = .0002) for the silicone tape as compared to the paper tape (Faces, Legs, Activity, Cry, and Consolability score mean difference from baseline 0.5 vs 3.3, P = .0002). Keratin removal was significantly less with the silicone as compared to paper tape (8.7 ± 0.5 µg/mL vs 15.2 ± 1.3 µg/mL, P < .0001). Few hairs were removed with either tape. There was significantly less (P < .0001) edge-lift with the paper tape than the silicone tape; no statistically significant differences in parent preferences for silicone versus paper tapes were measured (P = .3359). CONCLUSIONS: Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit.

Pharmacokinetic comparison of beclomethasone dipropionate extrafine aerosol from two inhaler devices in children with asthma.

OBJECTIVE: The primary objective was to test the comparability of the pharmacokinetics of beclomethasone dipropionate (BDP) delivered from a pressurized extrafine solution formulation in two inhalation devices in children with asthma. One inhaler was actuated using the press and breathe (P&B) technique and the other was breath-actuated (AH); both inhalers used HFA-134a as propellant. METHODS: Eighteen children aged between 9 years and 12 years entered and completed the study; written informed consent was obtained from all patients and their legal guardians. Each patient received, according to a randomized three-period crossover design, 200 microg BDP as four inhalations from 50 microg/actuation P&B, 200 microg BDP as four inhalations from 50 microg/actuation AH, and 400 microg BDP as four inhalations from 100 microg/actuation AH. Each patient was instructed on the proper use of each device once, at the screening visit. Patients self-administered all inhalations at the same time of day during the study without further coaching. Blood samples were collected for 24 h during each period to assay for the presence of BDP and metabolites. The log-transformed pharmacokinetic data were compared using a confidence-interval approach. RESULTS: Almost all the BDP-derived material in the plasma was the active metabolite beclomethasone 17-monopropionate; pharmacokinetic analyses were only performed for this metabolite. The ratios each of the pharmacokinetic parameters maximum plasma concentration (C(max)) and area under the plasma concentration-time curve (AUC), between the AH and P&B inhaler devices, were 0.94 and 1.1, respectively, and the corresponding 95% confidence intervals demonstrated comparability of the devices. Dose proportionality of C(max) and AUC between the 200-microg and 400-microg doses was similarly shown. About twice as many inhalation errors occurred during the P&B administration as during the AH periods, but the incidence was still low and did not result in any change in pharmacokinetics. CONCLUSION: The rate and extent of drug absorption was comparable from the P&B and AH inhaler devices in children with asthma. Dose proportionality was also observed.

Pharmacokinetics of beclomethasone 17-monopropionate from a beclomethasone dipropionate extrafine aerosol in adults with asthma.

OBJECTIVE: The objectives of this study were to test the dose and strength proportionalities of beclomethasone dipropionate (BDP) delivered from two strengths of a pressurized extrafine solution formulation. METHODS: Thirty adults with mild, stable asthma, aged between 18 years and 70 years, completed the study; written informed consent was obtained from all patients. Each patient received, according to a randomized four-period crossover design, 100 microg BDP as two inhalations from 50-microg/actuation strength, 100 microg BDP as one inhalation from 100-microg/actuation strength, 400 microg BDP as eight inhalations from the 50-microg/actuation strength, and 400 microg BDP as four inhalations from the 100-microg/actuation strength. Patients self-administered all inhalations at the same time of day during the study. Blood samples were collected for 12 h during each period to assay for the presence of BDP and metabolites. The log-transformed pharmacokinetic data were compared for proportionality equivalence using a confidence-interval approach. RESULTS: Almost all the BDP-derived material in the plasma was the active metabolite beclomethasone 17-monopropionate (17-BMP). Due to low levels, neither elimination half-life ( t(1/2)) nor the area under the plasma concentration-time curve (AUC) for 17-BMP could be calculated for the 100-microg BDP doses. Dose proportionality of the 100-microg and 400-microg BDP doses, using 17-BMP maximum plasma concentration (C(max)) was demonstrated for each strength. Strength proportionality of the 50-microg and 100-microg/actuation strengths was observed for C(max) at both dose levels and for AUC at the higher dose level. The t(1/2) of 17-BMP was found to be approximately 2.8 h. CONCLUSION: This study demonstrated both the strength and dose proportionalities of the BDP extrafine aerosol. This important information will allow physicians maximum flexibility in prescribing this aerosol product.