NCT06732609 Perioral Tissue Evaluation With Advanced Videodermoscopy (FAV)
| NCT ID | NCT06732609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Oral Mucosal Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-01-08 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Massimo Cordaro, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06732609 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 35 Years, studying Oral Mucosal Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06732609 currently recruiting?
Yes, NCT06732609 is actively recruiting participants. Contact the research team at andrea.camodeca@unicatt.it for enrollment information.
Where is the NCT06732609 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06732609 clinical trial?
NCT06732609 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Massimo Cordaro, MD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 80 participants.