Pilot Study Evaluating a 1726-nm Diode Laser Treatment for Fordyce Spots on the Lips

What this Trial Is About

Fordyce spots are harmless sebaceous glands commonly found on the lips and vermilion border, often causing cosmetic concerns. Researchers are evaluating the safety and effectiveness of a 1726-nm sebaceous-targeting diode laser Accure4 for treating these spots in a prospective pilot study. The study aims to assess improvements in appearance, patient satisfaction, and any side effects over several months. Participants will receive 2 to 3 laser treatment sessions spaced four weeks apart, using the Accure4 device which selectively targets sebaceous glands with temperature-guided, multi-pulse energy and continuous cooling. Treatments focus on the entire affected lip and vermilion area. Follow-up visits will occur at Weeks 4, 8, 12, and 24. An optional additional follow-up at Month 12 will observe longer-term effects without further treatment. During the study, participants will undergo assessments to count the number of Fordyce spots, rate global aesthetic improvements, and record satisfaction levels. Safety and tolerability will be monitored through Week 24, with extended safety observations at Month 6. Participants who opt out of the Month 12 visit will complete the study after Week 24, with no further contact beyond usual care. The total study duration includes treatment and follow-up visits over approximately six months, with optional extended observation.

1726-nm Diode Laser for Lip Fordyce Spots