PHOENIX – .
To characterize the sex of patients in trials evaluating hair removal with energy-based devices, Dr. Lee, an internal medicine intern at Beth Israel Deaconess Medical Center, Boston, and Jessica Labadie, MD, director of lasers and cosmetic surgery at the Icahn School of Medicine at Mount Sinai, New York, conducted a systematic review using PubMed with the search query hair AND laser AND removal AND (dermatology OR skin OR cutaneous). They limited the analysis to English-language clinical trials that investigated a laser and light-based therapy as an intervention and if hair reduction was an outcome, and excluded studies that did not include the face as a treatment area and laser hair removal for diseases with disproportionate occurrence in females or males, such as polycystic ovarian syndrome or pseudofolliculitis barbae.
Of 121 articles identified from the PubMed search, 28 studies involving 3,882 patients treated with lasers or intense pulsed light (IPL) for hair removal were included in the final analysis. Of these 28 articles, 22 (79%) reported the sex of trial participants. The population of these 22 studies included 3,104 (88.7%) females, 384 (11.0%) males, and 11 (0.003%) nonbinary identifying patients. None of the studies evaluated laser hair removal outcomes by sex.
“This study adds to the current knowledge of laser hair removal as a part of gender-affirming care by characterizing the representation of assigned sexes of patients in clinical trials evaluating the effectiveness of laser hair removal,” Dr. Lee told this news organization. “It highlights the underrepresentation of people assigned to male sex at birth in these clinical trials, despite this population’s potential interest in laser hair removal as a part of gender-affirming care.”
She acknowledged certain limitations of the review, including the absence of reporting on sex in the demographic sections of many trials and the exclusion of trials that did not include treatment of the face. “Clinicians need to be aware of the underrepresentation of men in clinical trials evaluating laser hair removal, and this may limit their understanding of treatment outcomes in this particular cohort,” she concluded. “Clinicians should emphasize inclusivity in future laser hair removal clinical trials and include outcomes by sex.”
The study “looks at an important aspect of clinical trials in the device-based space,” said Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was not involved in the study and was asked to comment on the results. “Laser hair removal is the most commonly performed procedure in aesthetic energy-based device dermatology. While these trials are often very small compared to drug trials, it highlights that men are a very underrepresented cohort in laser hair removal trials,” he said. “More recently, there is an increased interest in gender-affirming procedures, and this has highlighted the need to ensure we include a diverse spectrum of patients in devices-based research studies. This is a very challenging mandate but certainly one we should strive for to make efforts to be more inclusive when designing these clinical studies so that the information we gain from these studies is more broadly applicable.”
The researchers reported having no financial disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero, and holds stock in many device and pharmaceutical companies.