Gender, racial, ethnic, and Fitzpatrick skin type representation in Acanthosis nigricans clinical trials.
Acanthosis nigricans
Clinical trials
Ethnicity
Race
Representation
Skin of color
Journal
Archives of dermatological research
ISSN: 1432-069X
Titre abrégé: Arch Dermatol Res
Pays: Germany
ID NLM: 8000462
Informations de publication
Date de publication:
06 Jun 2024
06 Jun 2024
Historique:
received:
12
04
2024
accepted:
26
04
2024
revised:
12
04
2024
medline:
6
6
2024
pubmed:
6
6
2024
entrez:
6
6
2024
Statut:
epublish
Résumé
Acanthosis nigricans (AN) is characterized by dark, velvety patches and thin plaques primarily in the body folds. AN is more prevalent in skin of color populations, including Black/African American, Native American, and Hispanic patients. As the U.S. population becomes increasingly diverse, the need for inclusive dermatologic research becomes more pressing. Given the increased prevalence of AN in skin of color patients, there is a need to evaluate representation in AN clinical trials. This study aims to uncover gender, race, ethnicity, and Fitzpatrick skin type (FST) representation in AN clinical trials. A systematic literature search was performed across PubMed, Embase, and Cochrane databases to identify participant characteristics in clinical trials focused on AN treatment. Our review yielded 21 clinical trials, totaling 575 participants, with an identified predominance of female participants (69.0%) and a surprising absence of race or ethnicity data. Out of the 11 studies that included FST data, 1.2% of participants were type II, 20.6% were type III, 50.0% were type IV, and 28.2% were type V. None of the participants were FST I or VI. Herein, we highlight a predominate inclusion of female and FST III-V patients in AN clinical trials, the populations most impacted by this condition. We also highlight the need for improved race and ethnicity reporting and the importance of including all FSTs in clinical studies. Addressing this gap is critical for developing safe, efficacious, patient-centered, and equitable treatments for all AN patients. Future research should prioritize comprehensive inclusion of race, ethnicity, and the full spectrum of FSTs.
Identifiants
pubmed: 38842735
doi: 10.1007/s00403-024-02996-0
pii: 10.1007/s00403-024-02996-0
doi:
Types de publication
Journal Article
Systematic Review
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
332Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Das A, Datta D, Kassir M, Wollina U, Galadari H, Lotti T, Jafferany M, Grabbe S, Goldust M (2020) Acanthosis nigricans: a review. J Cosmet Dermatol 19(8):1857–1865. https://doi.org/10.1111/jocd.13544
doi: 10.1111/jocd.13544
pubmed: 32516476
Patel NU, Roach C, Alinia H, Huang WW, Feldman SR (2018) Current treatment options for acanthosis nigricans. Clin Cosmet Investig Dermatol 11:407–413. https://doi.org/10.2147/ccid.S137527
doi: 10.2147/ccid.S137527
pubmed: 30122971
pmcid: 6086114
Kong AS et al (2010) Acanthosis nigricans: high prevalence and association with diabetes in a practice-based research network consortium–a PRImary care multi-ethnic network (PRIME net) study. J Am Board Fam Med 23(4):476–485. https://doi.org/10.3122/jabfm.2010.04.090221
doi: 10.3122/jabfm.2010.04.090221
pubmed: 20616290
pmcid: 2948972
Nguyen TT, Keil MF, Russell DL, Pathomvanich A, Uwaifo GI, Sebring NG, Reynolds JC, Yanovski JA (2001) Relation of acanthosis nigricans to hyperinsulinemia and insulin sensitivity in overweight African American and white children. J Pediatr 138(4):474–480. https://doi.org/10.1067/mpd.2001.112657
doi: 10.1067/mpd.2001.112657
pubmed: 11295708
Stuart CA, Pate CJ, Peters EJ (1989) Prevalence of acanthosis nigricans in an unselected population. Am J Med 87(3):269–272. https://doi.org/10.1016/s0002-9343(89)80149-4
doi: 10.1016/s0002-9343(89)80149-4
pubmed: 2773965
Pirgon Ö, Sandal G, Gökçen C, Bilgin H, Dündar B (2015) Social anxiety, depression and self-esteem in obese adolescent girls with acanthosis nigricans. J Clin Res Pediatr Endocrinol 7(1):63–68. https://doi.org/10.4274/jcrpe.1515
doi: 10.4274/jcrpe.1515
pubmed: 25800478
pmcid: 4439894
U.S. Census Bureau (2020) Demographic Turning Points for the United States: Population Projections for 2020 to 2060. https://www.census.gov/library/publications/2020/demo/p25-1144.html . Accessed
Pew Research Center (2008) U.S. Population Projections: 2005–2050. https://www.pewresearch.org/hispanic/2008/02/11/us-population-projections-2005-2050/ . Accessed March 14, 2024
Elhage KG, Davis MS, Hakimi M, Spencer RK, Jin JQ, Yeroushalmi S, Chung M, Bartholomew E, Bhutani T, Liao W (2023) Ethnoracial representation in hidradenitis suppurativa clinical trials. Arch Dermatol Res 315(6):1793–1796. https://doi.org/10.1007/s00403-022-02510-4
doi: 10.1007/s00403-022-02510-4
pubmed: 36509944
Lebhar J, Jacobs J, Rundle C, Suggs A (2023) Skin of Color representation in laser therapy-based clinical trials. Dermatol Surg 49(8):812–813. https://doi.org/10.1097/dss.0000000000003834
doi: 10.1097/dss.0000000000003834
pubmed: 37235868
Mineroff J, Nguyen JK, Jagdeo J (2023) Racial and ethnic underrepresentation in dermatology clinical trials. J Am Acad Dermatol. https://doi.org/10.1016/j.jaad.2023.04.011
doi: 10.1016/j.jaad.2023.04.011
pubmed: 37062462
Ricardo JW, Qiu Y, Lipner SR (2022) Racial, ethnic, and sex disparities in nail psoriasis clinical trials: a systematic review. Skin Appendage Disord 8(3):171–178. https://doi.org/10.1159/000520469
doi: 10.1159/000520469
pubmed: 35707283
pmcid: 9149505
Chen ML (2006) Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 45(10):957–964. https://doi.org/10.2165/00003088-200645100-00001
doi: 10.2165/00003088-200645100-00001
pubmed: 16984210
Jagdeo J et al (2020) Safety of light emitting diode-red light on human skin: two randomized controlled trials. J Biophotonics 13(3):e201960014. https://doi.org/10.1002/jbio.201960014
doi: 10.1002/jbio.201960014
pubmed: 31483941
McKenzie S, Brown-Korsah JB, Syder NC, Omar D, Taylor SC, Elbuluk N (2022) Variations in genetics, biology, and phenotype of cutaneous disorders in skin of color. Part II: differences in clinical presentation and disparities in cutaneous disorders in skin of color. J Am Acad Dermatol 87(6):1261–1270. https://doi.org/10.1016/j.jaad.2022.03.067
doi: 10.1016/j.jaad.2022.03.067
pubmed: 35817332
Narla S, Heath CR, Alexis A, Silverberg JI (2023) Racial disparities in dermatology. Arch Dermatol Res 315(5):1215–1223. https://doi.org/10.1007/s00403-022-02507-z
doi: 10.1007/s00403-022-02507-z
pubmed: 36508020
Taylor SC (2002) Skin of color: biology, structure, function, and implications for dermatologic disease. J Am Acad Dermatol 46(2 Suppl Understanding):S41–62. https://doi.org/10.1067/mjd.2002.120790
doi: 10.1067/mjd.2002.120790
pubmed: 11807469
Kluczynik CE, Mariz LS, Souza LC, Solano GB, Albuquerque FC, Medeiros CC (2012) Acanthosis nigricans and insulin resistance in overweight children and adolescents. Bras Dermatol 87(4):531–537. https://doi.org/10.1590/s0365-05962012000400002
doi: 10.1590/s0365-05962012000400002
Ng HY (2017) Acanthosis nigricans in obese adolescents: prevalence, impact, and management challenges. Adolesc Health Med Ther 8:1–10. https://doi.org/10.2147/ahmt.S103396
doi: 10.2147/ahmt.S103396
pubmed: 28031729
Sudevan R, Vijay Kumar S, Sunny C, Sunand N, Vasudevan A, S SK, and A.P. V (2021) Prevalence of acanthosis nigricans and its association with physical activity in adolescents - school-based analytical cross-sectional study from Kochi, Kerala. J Family Med Prim Care 10(11):4218–4222. https://doi.org/10.4103/jfmpc.jfmpc_953_21
doi: 10.4103/jfmpc.jfmpc_953_21
pubmed: 35136792
pmcid: 8797089
Charrow A, Xia FD, Joyce C, Mostaghimi A (2017) Diversity in Dermatology clinical trials: a systematic review. JAMA Dermatol 153(2):193–198. https://doi.org/10.1001/jamadermatol.2016.4129
doi: 10.1001/jamadermatol.2016.4129
pubmed: 28055072
Ding J, Joseph M, Chawla S, Yau N, Khosa F (2022) Disparities in Alopecia Clinical Trials: an analysis of female and minority representation. J Cutan Med Surg 26(5):516–518. https://doi.org/10.1177/12034754221099667
doi: 10.1177/12034754221099667
pubmed: 35575099
National Institutes of Health (2018) Guidance for reporting valid analysis as required by the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NOT-OD-18-014). https://grants.nih.gov/sites/default/files/Valid%20analysis%20CTgov%20guidance%20final_508c.pdf . Accessed March 14, 2014
Food and Drug Administration (FDA) (2016) Collection of Race and Ethnicity Data in Clinical Trials Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/media/75453/download . Accessed March 14, 2024
Chang MJ, Qiu Y, Lipner SR (2021) Race reporting and representation in onychomycosis clinical trials: a systematic review. Mycoses 64(8):954–966. https://doi.org/10.1111/myc.13262
doi: 10.1111/myc.13262
pubmed: 33655595
Lopez-Alvarenga JC, García-Hidalgo L, Landa-Anell MV, Santos-Gómez R, González-Barranco J, Comuzzie A (2006) Influence of skin color on the diagnostic utility of clinical acanthosis nigricans to predict insulin resistance in obese patients. Arch Med Res 37(6):744–748. https://doi.org/10.1016/j.arcmed.2005.12.007
doi: 10.1016/j.arcmed.2005.12.007
pubmed: 16824934
Ghiasi M, Samii R, Tootoonchi N, Balighi K, Heidari S (2024) Comparison of efficacy and safety of tretinoin 0.05% and glycolic acid peeling 70% in axillary and neck lesions of acanthosis nigricans: a single-blinded, randomized trial. J Cosmet Dermatol. https://doi.org/10.1111/jocd.16224
doi: 10.1111/jocd.16224
pubmed: 38362706
Ehsani A, Noormohammadpour P, Goodarzi A, Mirshams Shahshahani M, Hejazi SP, Hosseini E, Azizpour A (2016) Comparison of long-pulsed alexandrite laser and topical tretinoin-ammonium lactate in axillary acanthosis nigricans: a case series of patients in a before-after trial. Casp J Intern Med 7(4):290–293
Kritsanaviparkporn C, Treesirichod A (2023) Comparing the efficacy and safety profiles of 0.025% and 0.05% tretinoin creams in treating acanthosis nigricans: a randomized double-blinded study. Arch Dermatol Res 315(4):963–970. https://doi.org/10.1007/s00403-022-02472-7
doi: 10.1007/s00403-022-02472-7
pubmed: 36416980
Leerapongnan P, Jurairattanaporn N, Kanokrungsee S, Udompataikul M (2020) Comparison of the effectiveness of fractional 1550-nm erbium fiber laser and 0.05% tretinoin cream in the treatment of acanthosis nigricans: a prospective, randomized, controlled trial. Lasers Med Sci 35(5):1153–1158. https://doi.org/10.1007/s10103-019-02944-9
doi: 10.1007/s10103-019-02944-9
pubmed: 31953736
Treesirichod A, Chaithirayanon S, Chaikul T, Chansakulporn S (2021) The randomized trials of 10% urea cream and 0.025% tretinoin cream in the treatment of acanthosis nigricans. J Dermatolog Treat 32(7):837–842. https://doi.org/10.1080/09546634.2019.1708855
doi: 10.1080/09546634.2019.1708855
pubmed: 31868565
Treesirichod A, Chaithirayanon S, Wongjitrat N (2019) Comparison of the efficacy and safety of 0.1% adapalene gel and 0.025% tretinoin cream in the treatment of childhood acanthosis nigricans. Pediatr Dermatol 36(3):330–334. https://doi.org/10.1111/pde.13799
doi: 10.1111/pde.13799
pubmed: 30883877