Sponsor study identifier
observational
80
1 country
1
Study Start
January 8, 2024
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary aim of this study is to characterize and systematically document the key dermato-mucosal structures of the perioral region in physiological conditions. Relative to the anterior chin area (ACA), the authors have tried to identify and describe pores, fine lines or wrinkles, texture patterns, superficial desquamation, hair follicles, sebaceous glands, fine ridges, grooves, sebaceous ducts, and skin irregularities. The observed features of the vermilion border (VB) and vermilion zone (VZ) include variations in color, texture, and surface characteristics, alongside the presence of fine lines and grooves. Vascular patterns and capillary visibility were observed, with pigmentation patterns providing additional insights into structural uniformity and non-uniform areas. Shiny surfaces, pore visibility, and regional differences in sebaceous activity and texture were also highlighted, reflecting the complex variability across the vermilion zone. Additionally, novel dermatoscopic and FAV findings not previously described in the literature were introduced into the analysis based on the personal observations of the investigators. This allowed for a comprehensive evaluation of the skin characteristics, providing a detailed analysis for each anatomical zone studied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2024
Actual (reported)December 9, 2024
Actual (reported)December 13, 2024
Actual (reported)September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Clinical evaluation of oral mucosa disease
To observed the anterior chin area (ACA), the authors have tried to identify and describe pores, fine lines or wrinkles, texture patterns, superficial desquamation, hair follicles, sebaceous glands, fine ridges, grooves, sebaceous ducts, and skin irregularities.
8 weeks
Clinical evaluation of perioral mucosa
To observed the vermilion border (VB) and vermilion zone (VZ) include variations in color, texture, and surface characteristics, alongside the presence of fine lines and grooves. Vascular patterns and capillary visibility were observed, with pigmentation patterns providing additional insights into structural uniformity and non-uniform areas.
8 weeks
Clinical evaluation of surface and texture of oral muocsa
To observed shiny surfaces, pore visibility, and regional differences in sebaceous activity and texture were also highlighted, reflecting the complex variability across the vermilion zone.
8 weeks
For the evaluation of healthy perioral tissues, the target population consisted of young, healthy individuals. The survey population specifically included students enrolled in the Dentistry and Dental Hygiene degree programs at the Catholic University of the Sacred Heart in Rome.
UOC Clinica Odontoiatrica, Fondazione Policlinico Agostino Gemelli IRCCS
Roma, 00168, Italy
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.
Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Massimo Cordaro, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
December 9, 2024
First Posted
December 13, 2024
Study Start
January 8, 2024
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Soglia S, Perez-Anker J, Lobos Guede N, Giavedoni P, Puig S, Malvehy J. Diagnostics Using Non-Invasive Technologies in Dermatological Oncology. Cancers (Basel). 2022 Nov 29;14(23):5886. doi: 10.3390/cancers14235886.
Sanlorenzo M, Vujic I, De Giorgi V, Tomasini C, Deboli T, Quaglino P, Fierro MT, Broganelli P. Fluorescence-advanced videodermatoscopy: a new method for in vivo skin evaluation. Br J Dermatol. 2017 Nov;177(5):e209-e210. doi: 10.1111/bjd.15594. Epub 2017 Oct 27. No abstract available.
Argenziano G, Soyer HP. Dermoscopy of pigmented skin lesions--a valuable tool for early diagnosis of melanoma. Lancet Oncol. 2001 Jul;2(7):443-9. doi: 10.1016/s1470-2045(00)00422-8.
Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.
Abati S, Bramati C, Bondi S, Lissoni A, Trimarchi M. Oral Cancer and Precancer: A Narrative Review on the Relevance of Early Diagnosis. Int J Environ Res Public Health. 2020 Dec 8;17(24):9160. doi: 10.3390/ijerph17249160.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 13, 2024
Record last verified: 2024-12
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