Jorge Roman1, John G Zampella2. 1. *Both authors are affiliated with the Ronald O. Perelman Department of Dermatology, New York University, New York, New York. 2. Both authors are affiliated with the Ronald O. Perelman Department of Dermatology, New York University, New York, New York.
Abstract
BACKGROUND: The demographics of men and minorities in clinical studies of nonsurgical cosmetic procedures have not been well described. There is a growing interest in nonsurgical cosmetic procedures. The patients studied in clinical trials may not be reflective of the real-world demographic of patients seeking nonsurgical cosmetic procedures. OBJECTIVE: To examine the demographics of men and minorities in clinical studies of nonsurgical cosmetic procedures. METHODS: A systematic review of clinical trials of botulinum toxin A (BTX-A) for facial rhytides and hyaluronic acid (HA) injectable fillers for soft-tissue augmentation was performed. Data on ethnicity and sex were collected and examined. RESULTS: Nineteen randomized controlled trials (RCTs) on BTX-A and 22 RCTs on HA were included for analysis. Men represented 11.8% of all participants. Men were more represented in the BTX-A RCTs (13.9%) compared with the HA RCTs (6.4%). Caucasian patients represented 67.1% of the total patients. Asian, Hispanic, and black patients represented 16.8%, 6.5%, and 5.4% of study participants, respectively. CONCLUSION: The proportion of men in clinical trials of BTX-A and HA reflects the real-world demographics of men undergoing these procedures. Hispanic and black patients were underrepresented in clinical trials.
BACKGROUND: The demographics of men and minorities in clinical studies of nonsurgical cosmetic procedures have not been well described. There is a growing interest in nonsurgical cosmetic procedures. The patients studied in clinical trials may not be reflective of the real-world demographic of patients seeking nonsurgical cosmetic procedures. OBJECTIVE: To examine the demographics of men and minorities in clinical studies of nonsurgical cosmetic procedures. METHODS: A systematic review of clinical trials of botulinum toxin A (BTX-A) for facial rhytides and hyaluronic acid (HA) injectable fillers for soft-tissue augmentation was performed. Data on ethnicity and sex were collected and examined. RESULTS: Nineteen randomized controlled trials (RCTs) on BTX-A and 22 RCTs on HA were included for analysis. Men represented 11.8% of all participants. Men were more represented in the BTX-A RCTs (13.9%) compared with the HA RCTs (6.4%). Caucasian patients represented 67.1% of the total patients. Asian, Hispanic, and black patients represented 16.8%, 6.5%, and 5.4% of study participants, respectively. CONCLUSION: The proportion of men in clinical trials of BTX-A and HA reflects the real-world demographics of men undergoing these procedures. Hispanic and black patients were underrepresented in clinical trials.