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Clinical Trials in Italy / NCT06732609
Recruiting Observational

Perioral Tissue Evaluation With Advanced Videodermoscopy (FAV)

NCT06732609 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-01-08
Last updated
2024-12-13

Condition(s) studied

Oral Mucosal Disorder

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Clinical evaluation of oral mucosa disease — 8 weeks
    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.
  • Clinical evaluation of perioral mucosa — 8 weeks
    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.
  • Clinical evaluation of surface and texture of oral muocsa — 8 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
UOC Clinica Odontoiatrica, Fondazione Policlinico Agostino Gemelli IRCCS Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06732609 on ClinicalTrials.gov ↗ ← All trials in Italy