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.

Real-life experience of a lidocaine/tetracaine self-occluding topical anesthetic for dermatological procedures.

BACKGROUND: Pliaglis® is a self-occluding topical anesthetic containing a eutectic mixture of 7% lidocaine and 7% tetracaine, with proven efficacy and safety in several trials. AIMS: To evaluate the effectiveness and safety of Pliaglis® for different dermatological procedures in real-life clinical practice. METHODS: This retrospective, multicenter study included 35 patients treated with Pliaglis® prior to five dermatological procedures (pulsed dyed laser, picosecond laser, non-ablative fractional laser, radiofrequency microneedling, and photodynamic therapy). The primary endpoint was to assess the pain during the procedure with a visual analogue score (VAS) from 0 (no pain) to 10 (most severe pain). Secondary endpoints were the global effectiveness and tolerability (from 0 = very low to 10 = excellent), and the adverse events (AEs) after Pliaglis® removal, classified according to intensity (1-3). RESULTS: The median and mean pain VAS reported by patients was 2 (range 0-9) and 2.9 (±2.3), respectively. More than 65% of the patients had a VAS score ≤3. The effectiveness reported by investigators was "very good" (median 8 [range 2-10], mean 7.5 [±1.9]), which was strongly correlated with the pain VAS reported by patients (Spearman coefficient = - 0.9; p < 0.001). Forty-five percent of patients reported AEs and they were transient and mostly mild, with a mean intensity score of 1.5 (range 1-3). Tolerability of Pliaglis® was reported by investigators as "excellent" (median 10 [range 1-10], mean 9 [±1.8]). CONCLUSIONS: Pliaglis® is an effective topical anesthetic for several dermatological procedures, with an excellent safety and tolerability profile.

Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure.

INTRODUCTION: While laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders. METHODS AND ANALYSIS: By reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry. ETHICS AND DISSEMINATION: An ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.

Treatment of gingival pigmentation with a 755-nm alexandrite picosecond laser.

Hyperpigmentation of the gums can be associated to several etiological factors. Although it is physiological in most cases it can cause esthetic concerns in some patients. The objective of our study was to evaluate the clinical efficacy and patient satisfaction with the treatment of gingival hyperpigmentation with picosecond alexandrite laser of 755 nm. We selected two patients with gingival hyperpigmentation on the anterior face of the upper and lower gums of years of evolution. Malignancy, drug ingestion, exposure to tobacco and underlying genetic and endocrine alterations were ruled out. Clinical photographs were taken before treatment and 2 weeks after the procedure. In both cases, anterior gingival areas were depigmented with satisfaction. The patients did not complain of severe pain or discomfort. Two weeks after the procedure the gingiva showed almost complete depigmentation. In conclusion, the 755-nm alexandrite picosecond laser seems to be safe and effective for the esthetic treatment of gingival hyperpigmentation.

Glomuvenous malformations: dual PDL-Nd:YAG laser approach.

Glomuvenous malformations are uncommon simple vascular malformations that might be present at birth or appear during childhood that have been classically classified as a subtype of venous malformations. Sclerotherapy and surgery have been used in the past as treatments for this condition although with disappointing results in large glomangiomas. The treatment of these lesions has still not been standardized. We conducted a retrospective study of 17 patients treated with dual wavelength PDL-Nd:YAG. The majority of the patients experience a reduction of at least a 60% in their glomuvenous malformations. Treatment was well-tolerated, and adverse effects were rare.

Treatment of flat and elevated pigmented disorders with a 755-nm alexandrite picosecond laser: clinical and histological evaluation.

The novel picosecond lasers, initially developed for faster tattoo removal, have also shown great efficacy in endogenous pigmentary disorders. To describe the efficacy and safety profile of an alexandrite (755-nm) picosecond laser in a wide range of pigmented flat and elevated cutaneous lesions. A retrospective study was performed in which we collected all the clinical images of patients treated with the 755-nm alexandrite picosecond laser for 12 months (November 2016-November 2017). Clinical features were obtained from their medical charts. Patients treated for tattoo removal were excluded. All the images were analyzed by three blind physicians attending to a visual analogue scale (VAS) from 0 to 5 (0, no change; 1, 1-24% clearance; 2, 25-49% clearance; 3, 50-74% clearance; 4, 75-99% clearance; 5, complete clearance). Patient satisfaction was obtained from a subjective survey including four items: very satisfied, satisfied, non-satisfied, and totally dissatisfied. Thirty-seven patients were included (12 males; 25 females). The mean age of the study was 42.35 years. Twenty-five patients (68%) were treated for different pigmented flat disorders such as solar and mucosal lentigines (5), stasis dermatitis (4), or nevus of Ota (4), among other diagnoses. Twelve patients (32%) were treated for epidermal elevated lesions such as warts (5), epidermal nevi (2), and seborrheic keratosis (3), among other elevated lesions. Mean number of laser treatment was 3.02 sessions while mean follow-up after last laser treatment was 4.02 months. Mean VAS score of the three observers was 3.44 (61% of clearance) for pigmentary flat disorders and 3.60 (67%) for elevated lesions. Adverse effects reported were mild blistering in the first 2-5 days following laser treatment in some of the patients. Overall satisfaction among the patients included was high. The novel 755-nm picosecond alexandrite laser is effective not only for the resolution of pigmented flat lesions of different nature but also for the treatment of the more difficult elevated pigmented lesions.