Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

Conditions

• Crows Feet
• Periorbital Area
• Periorbital Wrinkles
• Under-eyes Dark Circles

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Treatment with BTL-785 with the applicator BTL-785-7-11 — DEVICE
  The treatment administration phase will consist of four (n=4) treatments, delivered 2 -14 days apart. The applicator will be placed outside the orbital rim, on the subject's inferior orbital portion of the orbicularis oculi muscles and lateral canthal edge-temporal area. Therapy time is set to 20 minutes.

Study Details

The goal of this clinical trial is to determine the BTL-785-7-11 applicator effectiveness for an under-eye appearance improvement by evaluation of the periorbital area in healthy adult volunteers. The main question it aims to answer is: Whether the BTL-785-7-11 applicator is able to improve the periorbital area post-treatment, as assessed by the analysis of 3D photographs. Participants will complete four treatments and two follow-up visits.

Key Dates

Start date

Nov 5, 2024

Status verified

Jun 2025

Primary completion

Nov 9, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment with BTL-785 with the applicator BTL-785-7-11
  The treatment administration phase will consist of four treatment visits.

Primary Outcome Measure

Periorbital area improvement assessment [ Time Frame: baseline to 3 months post-treatment ]

Locations (3)

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