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2. Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

Author

Dirr, McKenzie A., Ahmed, Areeba, Schlessinger, Daniel I., Haq, Misha, Shi, Victoria, Koza, Eric, Ma, Melissa, Christensen, Rachel E., Ibrahim, Sarah A., Schmitt, Jochen, Johannsen, Lena, Asai, Yuka, Baldwin, Hilary E., Berardesca, Enzo, Berman, Brian, Vieira, Ana Carolina, Chien, Anna L., Cohen, David E., Del Rosso, James Q., Dosal, Jacquelyn, Drake, Lynn A., Feldman, Steven R., Fleischer, Alan B., Friedman, Adam, Graber, Emmy, Harper, Julie C., Helfrich, Yolanda R., Jemec, Gregor B., Johnson, Sandra M., Katta, Rajani, Lio, Peter, Maier, Lisa E., Martin, George, Nagler, Arielle R., Neuhaus, Isaac M., Palamar, Melis, Parish, Lawrence C., Rosen, Theodore, Shumack, Stephen P., Solomon, James A., Tanghetti, Emil A., Webster, Guy F., Weinkle, Allison, Weiss, Jonathan S., Wladis, Edward J., Maher, Ian A., Sobanko, Joseph F., Cartee, Todd V., Cahn, Brian A., Alam, Murad, Kang, Bianca Y., Iyengar, Sanjana, Anvery, Noor, Alpsoy, Erkan, Bewley, Anthony, Dessinioti, Clio, Egeberg, Alexander, Engin, Burhan, Gollnick, Harald P. M., Ioannides, Dimitrios, Kim, Hei Sung, Lazaridou, Elizabeth, Li, Ji, Lim, Hester Gail, Micali, Giuseppe, de Oliveira, Clivia Maria Moraes, Noguera-Morel, Lucero, Parodi, Aurora, Reinholz, Markus, Suh, Dae Hun, Sun, Qiuning, van Zuuren, Esther J, Wollina, Uwe, Zhou, Youwen, Zip, Catherine, Poon, Emily, and Pearlman, Ross

Abstract

IMPORTANCE: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. OBJECTIVE: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. EVIDENCE REVIEW: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. FINDINGS: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. CONCLUSIONS AND RELEVANCE: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Published
2024
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7. Skin type specific photobiological response to visible light is mediated by constitutional melanin.

Author

Lim, Hester Gail, Kerns, Michelle L., Brown, Isabelle D., Kang, Sewon, and Chien, Anna L.

Subjects
*VISIBLE spectra, *MELANINS, *IMMUNOSTAINING, *MATRIX metalloproteinases, *HEMATOXYLIN & eosin staining, *DNA damage
Abstract

Background: Visible light (VL) induces varying photobiological responses between skin types, likely influenced by inherent melanization. Individual typology angle (ITA) objectively measures skin types. We hypothesize that epidermal melanin content and distribution determine VL response. Objectives: This study describes clinical and histologic responses to VL and examines the potential role of melanin in the underlying mechanistic pathways. Methods: We grouped enrolled participants by ITA (Light = 5, Intermediate = 4, Dark = 7) per colorimetry (CR‐400, Konica Minolta). Photoprotected sites were exposed daily to 480 J/cm2 of VL (Fiber‐Lite High Intensity Illuminator, Series 180, Dolan Jenner Industries Inc.) for 4 days (total = 1920 J/cm2), as tolerated. Treated and control sites were biopsied 96 h after first exposure. We used hematoxylin and eosin and Fontana‐Mason to assess histological changes and melanin deposition, respectively. p53 and Ki67 immunohistochemical stains were done to assess DNA damage and proliferation. Matrix metalloproteinase (MMP)‐1 expression was detected by immunohistochemical staining and immunofluorescence microscopy. Results: Darker skin did not tolerate the full VL regimen with blistering occurring in most subjects at doses of 220–880 J/cm2. Intermediate and Dark skin showed tanning. Light skin developed erythema. p53 counts were highest in Intermediate, followed by Light skin, although this was not statistically significant. VL treatment led to MMP‐1 expression and nuclear localization in keratinocytes in Dark and Intermediate but not in Light skin, however differences between groups were not statistically significant. Conclusions: Skin types demonstrate unique biological responses to VL. The role of melanin in photoprotection is well‐defined. However, given the pro‐apoptotic function of nuclear MMPs, we suggest a potential mechanism by which melanin may mediate VL‐induced phototoxicity. [ABSTRACT FROM AUTHOR]

Published
2023
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