Perioral Tissue Evaluation With Advanced Videodermoscopy (FAV)

NCT06732609 | Recruiting DMC

• 1 other identifier: 3318
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucosal Disorder

Keywords

Videodermoscopy; FAV

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age: Participants must be between 20 and 35 years old
• Health Status: Participants must be in good general health with no known systemic diseases (ASA I)
• Skin Condition: Participants must have clinically healthy skin in the target area, with no history of dermatological conditions such as eczema, psoriasis, or dermatitis
• Consent: Participants must provide written informed consent to participate in the study
• Non-Smoking: Participants should be non-smokers or have quit smoking for at least 12 months
• Exposure: Must not have been recently exposed to treatments affecting the skin in the area of interest (e.g., laser treatments, chemical peels, or topical medications) within the last 3 months

You may not qualify if:

• Dermatological Disorders: History of skin diseases (e.g., acne, psoriasis, eczema) or other skin conditions that could interfere with the assessment
• Chronic Illnesses: Presence of chronic systemic conditions (e.g., diabetes, autoimmune diseases) that may affect skin health
• Medications: Current use of medications or treatments that could alter skin characteristics (e.g., corticosteroids, retinoids, immunosuppressants)
• Allergies: Known allergies to topical products used during the examination
• Pregnancy or Lactation: Pregnant or breastfeeding individuals are excluded due to potential skin changes during these periods
• Recent Skin Procedures: Any recent dermatological procedures (e.g., laser therapy, chemical peels) performed within the last 3 months in the area of evaluation
• Excessive Sun Exposure: Individuals with recent excessive sun exposure or sunburns in the target area within the last 2 months
• Non-Compliance: Individuals unwilling or unable to comply with the study procedures

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Clinica Odontoiatrica, Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 3377516 BACKGROUND

• 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.

  PMID: 8532986 BACKGROUND

• 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.

  PMID: 31896400 BACKGROUND

• 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.

  PMID: 36497368 BACKGROUND

• 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.

  PMID: 28421598 BACKGROUND

• 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.

  PMID: 11905739 BACKGROUND

• 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.

  PMID: 12451371 BACKGROUND

• 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.

  PMID: 33302498 BACKGROUND

Study Officials

• Massimo Cordaro, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Camodeca, DMD, MSc

CONTACT

+39 340 4226798; andrea.camodeca@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: January 8, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)