Assessment Of Skin Reactions Research Articles

First International Survey on Diabetes Providers' Assessment of Skin Reactions in Youth With Type 1 Diabetes Using Technological Devices.

Advances in diabetes technological devices led to optimization of diabetes care; however, long-lasting skin exposure to devices may be accompanied by an increasing occurrence of cutaneous reactions. We used an open-link web-based survey to evaluate diabetes-care providers' viewpoint on prevalence, management practices, and knowledge related to skin reactions with the use of diabetes technological devices. A post hoc analysis was applied to investigate differences in the level of awareness on this topic in relation to the experience in diabetes technology. One hundred twenty-five responses from 39 different countries were collected. Most respondents (69%) routinely examine patients' skin at each visit. All the preventive measures are not clear and, mainly, homogenously put into clinical practice. Contact dermatitis was the most frequently reported cutaneous complication due to diabetes devices, and its most common provocative causes are not yet fully known by diabetes-care providers. Almost half of the respondents (42%) had discussed the presence of harmful allergens contained in adhesives with device manufacturers. There is general agreement on the need to strengthen knowledge on dermatological complications. Although diabetes-care providers are quite aware of the chance to develop skin reactions in people with diabetes using technological devices, there are still some unmet needs. Large follow-up studies and further dissemination tools are awaited to address the gaps revealed by our survey.

A Randomised Clinical Feasibility Trial of a Breast Immobilisation Device: The SuPPORT 4 All Bra

AimsDespite the breast being a mobile organ, there is currently no standard suitable immobilisation device to optimise radiotherapy for women with larger breasts treated after a wide local excision. The SuPPORT 4 All (S4A) bra was co-designed with patients and radiotherapy professionals. The purpose of this study was to test the feasibility of using the S4A bra in the existing breast cancer radiotherapy pathway. Materials and methodsA randomised feasibility trial was conducted in a single institution; the primary feasibility endpoint was the recruitment of 50 participants. Efficacy endpoints were also tested, including assessment of skin reactions, dose to organs at risk and patient comfort. Fifty women were randomised to receive either standard radiotherapy with no immobilisation (control) or radiotherapy with the S4A bra (intervention). A separate planning study was undertaken on the cases randomised to receive the S4A bra. Participants in the intervention arm (S4A bra) underwent two planning computed tomography scans, one with the bra on and one without the bra; allowing direct comparison of organs at risk data for S4A bra versus no bra. ResultsAll women who started radiotherapy wearing the S4A bra completed treatment with the bra; patient comfort did not change across the 3 weeks of treatment. Positional accuracy using the bra was comparable with existing published accuracy for methods without immobilisation. The mean ipsilateral lung doses showed some improvement when positioning with the S4A bra was compared with the no bra set-up (3.72 Gy versus 4.85 Gy for right-sided cases, 3.23 Gy versus 3.62 Gy for left-sided cases). ConclusionsThe S4A bra is feasible to use in the radiotherapy pathway with good patient adherence. The S4A bra has potential to reduce dose to organs at risk (specifically ipsilateral lung dose) while maintaining good breast tissue coverage, and improved patient dignity, warranting further investigation on a larger scale.

Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum Contagiosum

Molluscum contagiosum (MC) is a highly contagious skin condition. Lesions may persist for months to years, and no US Food and Drug Administration-approved medications are currently available in the US. To assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of MC. This was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted MC or with MC only in the periocular area were excluded. Patients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks. The primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021. A total of 891 participants were randomized, 444 to berdazimer, 10.3% (mean [range] age, 6.6 [0.9-47.5] years; 228 [51.4%] male; 387 [87.2%] White individuals), and 447 to vehicle (mean [range] age, 6.5 [1.3-49.0] years; 234 [52.3%] female; 382 [85.5%] White individuals). In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% (397 patients) in the vehicle group had a lesion count performed at week 12. At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8; P < .001) with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of MC clearance compared with 8.9% (40 patients) of the vehicle group. Adverse event rates were low. The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group. The most common local skin reaction was mild to moderate erythema. Use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates. ClinicalTrials.gov Identifier: NCT04535531.

Standardised assessment of COVID-19 vaccine-related skin reactions

Standardised assessment of COVID-19 vaccine-related skin reactions

Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial.

We conducted a randomized, double-blind, vehicle-controlled clinical trial to investigate the use of a new proprietary hyaluronan (HA) formulation for the prevention of acute skin toxicity in breast cancer patients undergoing radiotherapy (RT). Thirty women with breast cancer undergoing whole breast RT were enrolled. Each patient was randomly assigned to HA formulation (study cream, S) on the medial or lateral half of the irradiated breast and the control cream (placebo, P) on the other half. The primary endpoint was physician's evaluation of skin symptoms at week 5 during RT and week 2 post-RT. We also collected patients' independent assessment of skin after RT, patient's product preference, and an independent physician panel assessment of skin reactions based on photographs. Twenty-eight patients were evaluable. On physician's evaluation, there was no significant difference in radiation dermatitis between S and P and no overall preference to either cream at week 5 during or week 2 post-RT. More patients preferred S in evaluating skin appearance and skin reactions, but this did not reach statistical significance. Univariate analysis showed that physicians had an overall preference to the S cream at week 2 post-RT in patients with larger breasts. On the independent panel assessment, 3 reviewers saw no significant difference in radiation toxicity, whereas one reviewer reported better skin outcome with S cream at week 5. We found a nonstatistically significant patient preference but overall no significant radioprotective effects for this HA formulation compared with placebo except in patients with larger breasts. The study was registered at www.clinicaltrials.gov (NCT02165605).

Novel Hyaluronan Formulation for Preventing Acute Skin Reactions in Breast During Radiation Therapy: A Randomized Clinical Trial

Multiple studies have investigated the effects of hyaluronan (HA) for the prevention or management of acute skin reactions during breast radiotherapy (RT) with conflicting results. In this study, we conducted a randomized, double blind, vehicle-controlled clinical trial to investigate the use of a new proprietary HA formulation for the prevention of acute skin toxicity in breast cancer patients undergoing RT. This new formulation of small and large molecular weight HA has high water retention properties and is designed to provide controlled release and slow delivery of various skin moisturizing ingredients including HA. Thirty women with breast cancer undergoing whole breast RT (50.4 Gy with a 10 Gy boost) after lumpectomy were enrolled in this study. Each patient was randomly assigned to the HA formulation (study cream, S) on the medial or lateral half of the irradiated breast, and the control cream (placebo, P) on the other half. The primary endpoint was physician's evaluation of skin symptoms at week 5 during RT and week 2 post-RT. We also collected patients’ independent assessment of skin appearance/reactions to RT, patient’s product preference and an independent physician panel assessment of skin reactions based on photographs. Breast size was classified into 3 main categories: small (bra sizes 32A or 32B, 34A or 34B, and 36A), medium (bra sizes 32C, 34C, 36B or 36C, and 38A, 38B, or 38C), or large (larger bra sizes). Twenty-eight evaluable patients were included in the final analysis. On physician’s evaluation, there was no significant difference in the NCI-CTC radiation dermatitis grades at week 5 during (p=1.00) and week 2 after RT (p=0.43) between S and P. Likewise, skin desquamation was similar between S and P at both time points. Physicians had no overall preference when comparing the study versus placebo creams at week 5 (p=0.41) and week 2 after RT (p=0.80). More patients preferred the study serum in evaluating skin appearance (39 vs 18% at week 5 and 39 vs 22% at week 2 after RT) and skin reactions (46 vs 25% at week 5 and 46 vs 29% at week 2 after RT), but this did not reach statistical significance. Univariate analysis showed that physicians had an overall preference to the S cream at week 2 after RT (p=0.04) in patients with large breasts (compared to small and medium sized breasts). We found an increase in patient preference but overall no significant radioprotective effects for this HA formulation compared to placebo, however, patients with large breasts may benefit.

Quantitative Assessment of Chronic Skin Reactions Including Erythema and Pigmentation after Breast Conserving Therapy

Purpose: To evaluate long-term skin reactions following breast-conserving therapy by using the melanin-erythema index meter. Patients and Methods: 164 patients were followed for at least three years after breast-conserving therapy. For both the erythema and the melanin indices, the ratio of the irradiated-side index to the non-irradiated-side index was calculated. The time course of index ratios alternation was examined. Influences from additional therapies and patients’ age were also evaluated. Result: Both erythema and melanin index ratios of the breast skin were recovered to pre-radiation level three years after radiotherapy. However, both index ratios of the area administrated with 10-Gy boost irradiation were still high even after five years after radiotherapy. Endocrine therapy, chemotherapy and age had no significant influence on skin color reactions three years after radiotherapy. Conclusion: Quantitative assessment using the melanin-erythema index meter demonstrated that chronic skin reactions following breast conserving therapy had recovered to pre-radiation level for three years after irradiation except for the 10-Gy boost irradiated area.

Assessment of local skin reactions with a sequential regimen of cryosurgery followed by ingenol mebutate gel, 0.015%, in patients with actinic keratosis.

Lesion-directed and field-directed therapies are used to treat actinic keratosis (AK). Therapeutic approaches that combine both types of therapies may improve the successful elimination of AKs. A randomized, double-blind, vehicle-controlled study evaluated the safety, tolerability, and efficacy of topical field treatment with ingenol mebutate gel, 0.015%, after cryosurgery to AKs on the face and scalp. Patients with 4–8 visible discrete AKs in a 25-cm2 contiguous area received cryosurgery of all AKs at baseline. After a 3-week healing period, patients applied ingenol mebutate gel, 0.015%, or vehicle gel once daily for 3 consecutive days to the treatment area. The incidence, severity, and time course of the development and resolution of local skin reactions were measured from baseline to week 11. Local skin reactions peaked shortly after completion of ingenol mebutate treatment and generally resolved within 2 weeks. The mean (95% confidence interval) composite score (maximum range, 0–24) for these reactions was higher in patients with treatment of AKs on the face, 9.3 (8.5–10.1), as compared with the scalp, 5.8 (4.3–7.4). Erythema and flaking/scaling were the major contributors to the composite local skin reaction score. These results show that local skin reactions associated with ingenol mebutate treatment of the face or scalp are well tolerated after recent cryosurgery.

Direct comparison of laser Doppler flowmetry and laser Doppler imaging for assessment of experimentally-induced inflammation in human skin

Laser Doppler imaging (LDI) and laser Doppler flowmetry (LDF) can measure localized skin perfusion. The purpose of the study was to directly compare LDF with LDI as a tool for measuring skin blood changes in an experimental model of chemically-induced skin inflammation. Regions of interest 1.8 cm² in area on the forearm skin of eight healthy volunteers were randomized and exposed to 0.25, 0.5, 1, or 2 % topical sodium lauryl sulfate (SLS) or vehicle for 24 h. Mean blood flow was measured by LDI and LDF at 24, 48, and 72 h. Inflammation was clinically graded using a standardized, clinical score. Sodium lauryl sulfate induced significant, dose-dependent local inflammation. Both Doppler methods were significantly correlated with the clinical grading (LDF, r = 0.755; LDI, r = 0.836). LDF and LDI showed similar significance differences with regard to dose- and time-response patterns compared to the vehicle. The absolute and relative LDF and LDI values were significantly correlated. Laser Doppler flowmetry and LDI showed similar dose- and time-response relations in irritant-induced inflammatory skin reactions. For the assessment of localized skin reactions, LDI possesses no apparent advantages over the less expensive LDF method for grading dermal inflammatory reactions.

Interrater Variability in the Assessment of Skin Reactions in Breast Cancer Radiation Therapy: Impact of Grading Scales

The purpose of this work was to evaluate inter-rater variability between radiation oncologists and nurses in the use of grading scales for the assessment of skin reactions in breast cancer radiation therapy.

Historical perspective on the use of visual grading scales in evaluating skin irritation and sensitization

Visual assessment of skin reactions has long been used to evaluate the safety of chemicals and preparations that contact the skin, and to meet regulatory requirements. This article reviews the history of visual grading scales, and the results of investigations into the reliability of the method. Some examples are provided to illustrate the diverse array of protocols that use visual scoring to evaluate skin irritation. Furthermore, as bioengineering methods are developed that can quantitate certain aspects of skin irritant and sensitization reactions, it is important to consider whether such measures should supplement or replace visual assessment. Examples of investigations comparing the outcomes of studies that use visual scoring and those that use bioengineering methods are discussed. These examples provide little evidence that bioengineering measures provide an improvement in overall quality in comparison with current testing methods that rely on visual assessment. In addition, such measuring techniques can add considerably to the complexity of testing protocols. When benefits and cost are weighed in the balance, the visual assessment scales popularized by Draize and others remain an effective, practical method of evaluation.

Assessment of Allergic Skin Reactions and their Inhibition by Antihistamines using Photoplethysmography Imaging (PPGI)

Assessment of Allergic Skin Reactions and their Inhibition by Antihistamines using Photoplethysmography Imaging (PPGI)

20 MHz ultrasonic imaging for quantitative assessment and documentation of early and late postradiation skin reactions in breast cancer patients

Background and purpose: In dermatology high resolution ultrasonic systems proved to be valuable in following up genuine and experimental inflammatory dermatoses. The opportunities of 20 MHz ultrasonic imaging for quantitative assessment of early and late postradiation skin reactions are investigated. Material and methods: Between April and November 1996, 96 high resolution ultrasound examinations of the skin in 29 patients treated for breast cancer at the University of Ulm were analyzed. Total doses between 46 and 60 Gy were applied. The time interval between the completion of radiotherapy and ultrasonic examination was ≤3 months in 18 patients and 6–135 months in 11 patients. For examinations we used a digital high resolution ultrasonic system with a ceramic 20 MHz transducer. Irradiated and non-irradiated skin were compared. Results: A change of thickness and texture of the dermis depending on the time interval between the completion of radiotherapy and ultrasonic examination and on the administered radiation dose was found. There were significant differences between irradiated and non-irradiated skin regarding the dermal thickness in early ( P<0.001) as well as in late ( P=0.0018) reactions. Echogenicity of the upper and lower corium of irradiated skin decreased in early and late reaction. In upper corium the greatest reduction of signal intensity occurred in early reactions ( P=0.0001). Early reactions of the lower corium differed significantly from late changes ( P=0.001). Discrepancies between visible skin reactions described by examining physicians and ultrasonically proven changes were obvious mainly in late reactions. Conclusions: There are specific textures of early and late postradiation skin reactions in comparison to non-irradiated skin. High resolution digital 20 MHz ultrasound is non-invasive and quantitative, and in contrast to physical examination, an easy reproducible method for assessing and documenting early and late skin reaction during and after radiation therapy treatment.

450 - Quantitative assessment of early and late postradiation skin reactions in breast cancer patients

450 - Quantitative assessment of early and late postradiation skin reactions in breast cancer patients

Progressive evaluation of skin irritancy of cosmetics using human volunteers

Synopsis Cosmetics and toiletries should not elicit adverse reactions in use. Neither should they cause unacceptable effects if mis-used. Reliable prediction of these product attributes can be achieved by subjecting human volunteers to typical product exposure and to grossly exaggerated exposure. However, to ensure that volunteers do not sustain harmful effects there needs to be a cautiously progressive programme of testing. There must be adequate data on record to support exposure of human skin to the test material. The first contact with human skin should be in a small area, for short duration, and be very closely observed. When the effects are well within acceptable limits the exposure can be extended. As information accumulates, the application procedure can evolve towards simulation of the intended use of the product under controlled conditions, and eventual free use in consumer tests; and also towards exaggerated use to evaluate potential irritancy, using exaggerated frequency of use, exaggerated product concentration, or occlusive cover to promote skin penetration and enhance irritancy. Skin reactions under exaggerated exposure conditions do not necessarily mean that a product would be unacceptable under normal use conditions or when misused predictably. Therefore, appropriate standard products must be included in tests to provide relevant comparison when significant skin reaction does occur. Data will be presented to demonstrate progressive evaluation of irritancy of cosmetics and toiletries, based on expert assessment of visible skin reactions and on analysis of spontaneous and prompted comments about subjective effects, and including appropriate attention to the ethical requirements for tests involving human volunteers.