Evaluation of perioral tissue using advanced videodermoscopy
Clinical Evaluation and Characterization of Normal Perioral Tissue With a New Advanced Videodermoscopy Method. A Pilot Study on Dental Students.
This study is testing the skin around the mouth in young adults to see what healthy tissue looks like, which could help with understanding mouth-related skin issues in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Roma) |
| Trial ID | NCT06732609 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically document the characteristics of healthy perioral tissue in young adults aged 20 to 35. Utilizing advanced videodermoscopy, the study focuses on identifying various dermato-mucosal structures, including pores, fine lines, and texture patterns in the perioral region. A total of 40 participants will be assessed to ensure a reliable evaluation of skin characteristics, while controlling for confounding factors such as age, gender, and environmental exposure. The findings are intended to inform future larger-scale studies on oral mucosal disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy young adults aged 20 to 35 with no history of dermatological conditions.
Not a fit: Patients with existing skin disorders or chronic systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of perioral skin characteristics, potentially leading to improved diagnostic and treatment approaches for oral mucosal disorders.
How similar studies have performed: While this study employs a novel approach, similar observational studies have shown promise in characterizing skin conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- UOC Clinica Odontoiatrica, Fondazione Policlinico Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Cordaro, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Andrea Camodeca, DMD, MSc
- Email: andrea.camodeca@unicatt.it
- Phone: +39 340 4226798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.