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.

Fractional erbium-doped yttrium aluminum garnet laser-assisted drug delivery of hydroquinone in the treatment of melasma.

BACKGROUND: Melasma is a difficult-to-treat hyperpigmentary disorder. Ablative fractional laser (AFL)-assisted delivery of topically applied drugs to varied targets in the skin has been an area of ongoing study and research. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of fractional erbium-doped yttrium aluminum garnet (Er:YAG) laser as an assisted drug delivery for enhancing topical hydroquinone (HQ) permeation into the skin of melasma patients. PATIENTS AND METHODS: Thirty female patients with bilateral melasma were randomly treated in a split-face controlled manner with a fractional Er:YAG laser followed by 4% HQ cream on one side and 4% HQ cream alone on the other side. All patients received six laser sessions with a 2-week interval. The efficacy of treatments was determined through photographs, dermoscopic photomicrographs and Melasma Area Severity Index (MASI) score, all performed at baseline and at 12 weeks of starting therapy. The patient's level of satisfaction was also recorded. RESULTS: Er:YAG laser + HQ showed significantly better results (p<0.005) with regard to decrease in the degree of pigmentation as assessed on the 4-point scale than HQ alone. There was a significant decrease in MASI scores on Er:YAG laser + HQ side vs HQ side. Minor reversible side effects were observed on both sides. CONCLUSION: AFL-assisted delivery of HQ is a safe and effective method for the treatment of melasma.

Phototherapy in the treatment of acne vulgaris.

BACKGROUND: Achieving an effective management of acne vulgaris with minimal complications remains a difficult challenge for physicians. Moreover, the rise in antibiotic-resistant strains reduce the future usefulness of current mainstay therapies, and accordingly, the need for alternative therapies is mandatory. Phototherapy has been shown to be an effective treatment for acne, and there has been a renewed interest in photodynamic therapy as a treatment modality for this condition. OBJECTIVES: To evaluate the effectiveness of pulsed dye laser (PDL), intense pulsed light (IPL) and light-emitting diode (LED) phototherapy for the treatment of moderate to severe acne vulgaris. METHODS: Forty-five patients with moderate to severe acne were randomly divided into 3 equal groups. Group 1 was treated with a PDL, group 2 was treated with IPL, and group 3 was treated with a blue-red combination LED. Treatment was continued until a > or = 90% clearance of patient lesions was achieved. Clinical assessments were conducted before starting treatment, at 1 month as a midpoint evaluation, and after the final treatment session. RESULTS: Patients treated with the PDL reached a > or = 90% clearance of their inflammatory lesions after a mean of 4.1 +/- 1.39 sessions, while patients treated with IPL required a mean of 6 +/- 2.05 sessions. Patients treated with the LED required a mean of 10 +/- 3.34 sessions. At the mid-point evaluation, the percent reduction in acne lesions treated with the PDL was 90% or more, in cases of IPL and the LED, the percent reductions were 41.7% and 35.3%, respectively. Laser and light phototherapy sessions were well tolerated with minimal adverse events experienced as being mild and usually self-limiting. CONCLUSIONS: The encouraging results of the present study contributes evidence of phototherapy as useful therapeutic option for treatment of moderate to severe acne, and validates further studies to evaluate treatments with a larger number of patients and for a longer period of follow-up.