A core outcome domain set for clinical research on capillary malformations (the COSCAM project):an e-Delphi process and consensus meeting

BACKGROUND: There is limited evidence on the best available treatment options for capillary malformations (CMs), mainly due to the absence of uniform outcome measures in trials on therapies. A core outcome set (COS) enables standard reporting of trial outcomes, which facilitates comparison of treatment results. OBJECTIVES: To develop a core outcome domain set (CDS), as part of a core outcome set (COS), for clinical research on CMs. METHODS: Sixty‐seven potentially relevant outcome subdomains were recognized based on the literature, focus group sessions, and input from the COSCAM working group. These outcome subdomains were presented in an online Delphi study to CM experts (medical specialists and authors of relevant literature) and (parents of) patients with CM (international patient associations). During three e‐Delphi study rounds, the participants repeatedly scored the importance of these outcome subdomains on a seven‐point Likert scale. Participants could also propose other relevant outcome subdomains. Consensus was defined as ≥ 80% agreement as to the importance of an outcome subdomain among both stakeholder groups. The CDS was finalized during an online consensus meeting. RESULTS: In total 269 participants from 45 countries participated in the first e‐Delphi study round. Of these, 106 were CM experts from 32 countries, made up predominantly of dermatologists (59%) and plastic surgeons (18%). Moreover, 163 (parents of) patients with CM from 28 countries participated, of whom 58% had Sturge–Weber syndrome. During the two subsequent e‐Delphi study rounds, 189 and 148 participants participated, respectively. After the entire consensus process, consensus was reached on 11 outcome subdomains: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health‐related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence. CONCLUSIONS: We recommend the CDS to be used as a minimum reporting standard in all future trials of CM therapy. Our next step will be to select suitable outcome measurement instruments to score the core outcome subdomains. What is already known about this topic? Besides physical and functional sequelae, capillary malformations (CMs) often cause emotional and social burden. The lack of uniform outcome measures obstructs proper evaluation and comparison of treatment strategies. As a result, there is limited evidence on the best available treatment options. The development of a core outcome set (COS) may improve standardized reporting of trial outcomes. What does this study add? A core outcome domain set (CDS), as part of a COS, was developed for clinical research on CMs. International consensus was reached on the recommended core outcome subdomains to be measured in CM trials: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health‐related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence. This CDS enables the next step in the development of a COS, namely to reach consensus on the core outcome measurement instruments to score the core outcome subdomains. What are the clinical implications of this work? The obtained CDS will facilitate standardized reporting of treatment outcomes, thereby enabling proper comparison of treatment results. This comparison is likely to provide more reliable information for patients about the best available treatment options

Characterisation and treatment of patients with port wine stains with special reference to the emotional impact

This thesis covers 12 years of experience in treating patients with congenital capillary malformations, so called port wine stains (PWS). The wide variation in treatment response to laser therapy has developed a profound need for the development of objective devises to measure treatment outcome, so that the maximum effectiveness of therapy can be achieved without unnecessary treatments. The purpose has been to better characterise PWS with the emphasis on blood flow, erythema, depth, so that the results of the treatment can be better (if possible) predicted, followed, documented and improved. We found that laser doppler imaging (LDI-a new technique) in the measurement of blood flow in PWS was more useful in research settings than as a predictive tool. Reflectance spectrophotometry has been superior to LDI in the prediction of the outcome of PWS therapy. It is objective and correlates well with clinical results and is also portable and easy to use. Skin ultrasound can help to characterise the PWS in the majority of patients and may help to predict the outcome of PDL treatment. With the help of special questionnaires, developed in collaboration with a child and adolescent psychiatrist, we have investigated the psychological and psychosocial impact a PWS can have on the individual according to the individual themselves or their family members. There is a high risk of developing negative parameters e.g. low self- esteem, school problems and difficulties in social relationships if you have a PWS, but the majority of these negative parameters can improve after the treatments

Laser tattoo removal, precautions, and unwanted effects.

Laser tattoo removal uses the physical properties of photoselective thermolysis in order to remove tattoo pigment. The technique has gradually improved over the years with the development of Q-switched lasers, with overall good results and a relatively low degree of adverse effects. However, lasers cannot always erase the unwanted tattoo completely, and there are still risks of unwanted effects such as scarring, pigment changes, ink darkening, and potential aggravation of latent skin conditions. This chapter will discuss the precautions that have to be taken and what pitfalls to avoid before starting the procedure of laser tattoo removal. © 2015 S. Karger AG, Basel

Laser therapy for refractory discoid lupus erythematosus when everything else has failed

Background: Discoid lupus erythematosus (DLE) is restricted to the skin, mostly the face, often chronic and disfiguring. Standard medical therapies include topical corticosteroids and antimalarials. This is a retrospective long-term follow-up of refractory DLE treated with different lasers and intense pulsed light (IPL). Methods and materials : Sixteen patients with histologically confirmed DLE participated in this study. Two men and fourteen women, aged 28-69 years, mean age 54 years, were treated at the laser units of the Departments of Dermatology at the University Hospital of Orebro from 2001 and at Skane University Hospital in Malmo, Sweden from 1999. Several therapies, including first- and secondline treatments and even cryotherapy, had been used without response. Many patients had marked scarring. Pulsed dye laser (PDL) and IPL were used with low fluencies. Results: Of 16 patients, 14 were improved regarding itching, erythema, scaling, scarring and pain. There was no scarring as a side effect of laser therapy or IPL. Two patients were not satisfied: one because of long healing time, and the other because of post inflammatory hyper pigmentation. Conclusion: IPL and PDL is a safe adjunctive therapy to conventional treatment of DLE. In the effort to prevent severe scarring and disfigurement it should be used as early as possible

5-ALA for photodynamic photorejuvenation - Optimization of treatment regime based on normal-skin fluorescence measurements

Background and Objectives: Photodynamic therapy using 20% 5 aminolevulinic acid (5-ALA) has recently been introduced as a new tool in optical skin rejuvenation. The primary objective of this study was to optimize incubation time, the topical delivery mechanism (vehicle) and the concentration of 5-ALA by detecting the dynamic changes of normal skin after 5-ALA application. The secondary objective was to develop a treatment regime which minimizes post-treatment photosensitivity. Study Design/Materials and Methods: Skin fluorescence distribution patterns after topical application of low concentrations of 5-ALA (0.5% and 1% preparations encapsulated in liposomes), were investigated. Twenty percent 5-ALA in moisturizing cream was used as a control. Ten healthy volunteers participated, and skin fluorescence was documented by fluorescent photography. The fluorescent intensity was measured in % of maximum obtained fluorescence after 3 hours 5-ALA application. Results: Skin fluorescence intensity after topical application of 0.5% and 1% non-occluded liposome-encapsulated 5-ALA application was heterogeneous distributed and reached saturation level after approximate 2 hours. The maximal fluorescence for 0.5% and 1% 5-ALA treated areas was 4.2% (SD: 3.5%) and 2.4% (SD: 2%), respectively, and this difference was statistically significant (P = 0.036). The fluorescence decayed linearly shortly (within 15 minutes) after end of application and was back to baseline within 8 hours. In contrast, the fluorescence of areas treated more than 1 hour with 20% 5-ALA was very uniform and a linear relationship (r 2 = 0.998) to the incubation time (0-3 hours) was registered. Furthermore, fluorescence intensity (15.2-57.9%) continued to increase after the end of 5-ALA application. The maximum fluorescence reach a level of 1.6-9 times the fluorescence measured by end of the 5-ALA application and occurred 8:13 hours (SD: 0:49 hours) after the end of 20% 5-ALA application. The average skin surface fluorescence induced by the liposome-encapsulated 0.5% 5-ALA applied for longer than 2 hours, was found to be statistically equal (P = 0.47) to the average measured skin surface fluorescence (4.2%) obtained after 30 minutes exposure to 20% 5-ALA cream (4.3%). Conclusion: Changing the 5-ALA vehicle from a moisturizing cream to liposome encapsulation, the 5-ALA concentration can be lowered by a factor of 40, and still induce the same skin fluorescence and at the same time eliminates the need for occlusion. The low post-treatment fluorescence also suggests a significantly reduced risk of post-treatment phototoxicity. Lasers Surg. Med. 39:302-310, 2007

Epilation today: Physiology of the hair follicle and clinical photo-epilation

Despite the variations of length and type of hair (vellus or terminal), the growth of human hair in all body sites is cyclic. Phases of active hair growth, or anagen, are separated by periods of quiescence, or telogen. The duration of both phases varies greatly depending on the body site. Whether hairs are in anagen/telogen at the time of hair removal is important because only anagen hairs are particularly sensible to physical insults. Photo-epilation is a technique for long-term removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). As melanin is the main chromophor existing in hair follicles the corresponding wavelength spectrum would range from ultraviolet up to infrared light. Furthermore longer wavelengths are preferred as the cromophor lies deep in the skin and the penetration of light is increasing with the wavelength. Thus, in the range of 600-1100 nm melanin absorption may be used for selective photothermolysis of hair follicles. Yet to be resolved questions for permanent destruction are the location of the key follicular target and the possible influence of the hair growth cycle on photothermolysis-induced hair removal. An overview on the individual physiology of the hair follicle is given to discuss the latest strategies for photo-epliation

Improvement of microstomia in scleroderma after intense pulsed light: A case series of four patients.

Introduction: Intense pulsed light (IPL) treatment is well known for, for example, photo rejuvenation, where higher cut-off filters are used. The longer wavelengths penetrate deeper in the dermis leading to damage of the collagen and stimulation of new collagen formation, which lead to more soft and elastic skin. Microstomia in systemic sclerosis is the end result of excessive collagen deposition, which makes the perioral skin firm and tight. The patients have difficulties performing oral self-care, and even professional dental care can be complicated. Methods: Four patients with systemic sclerosis and microstomia were treated with IPL (Ellipse A/S Flex System, Denmark ) in the perioral region. The patients received 3-5 treatments with 4-week interval. Oral opening was measured before and after treatments. Results: The oral opening increased approximately 1 mm per treatment in three patients. One patient had temporomandibular joint symptoms of locking and did not have any increase in mouth opening. All four patients felt softening of the perioral skin, and all four patients described that articulation, eating and tooth brushing had become easier. Conclusion: IPL can be a new adjunctive alternative in the non-surgical treatment of microstomia in patients with systemic sclerosis