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Efficacy and Safety of InMode Forma Bipolar Radiofrequency for the Treatment of Periorbital Wrinkles and Laxity

Efficacy and Safety of InMode Forma Bipolar Radiofrequency for the Treatment of Periorbital Wrinkles and Skin Laxity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127281
Enrollment
Unknown
Registered
2026-06-29
Start date
2026-06-29
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periorbital wrinkles and laxity

Interventions

treatment side vs. control side:The left and right periorbital areas of each participant were randomly assigned, with one side designated as the treatment side that received bipolar radiofrequency tre

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female subjects aged 35–65 years; 2. Mild to moderate periorbital skin laxity or fine lines bilaterally, with or without mild to moderate lower eyelid tissue protrusion (skin laxity type or mild fat protrusion type bags under eyes); 3. Generally symmetrical periorbital wrinkles and skin laxity between left and right eyes, with at least one periorbital site (lateral canthal area, infraorbital area, or medial canthal area) scoring Grade I–II on the Fitzpatrick Wrinkle and Elastosis Scale (FWES); 4. Intact skin without significant scarring, active inflammation, infection, or other dermatological conditions that may affect energy-based treatment; 5. Subjects voluntarily participating in the study, having signed the informed consent form, and capable of completing all treatments and follow-up visits as scheduled.

Exclusion criteria

Exclusion criteria: 1. History of periorbital radiofrequency, ultrasound, laser, injectable filler, or surgical treatments within 6 months prior to enrollment; 2. Presence of significant orbital septal fat herniation (moderate to severe bags under eyes), or marked lower eyelid edema, lymphatic drainage impairment type bags under eyes; 3. Concomitant severe ocular diseases (such as dry eye syndrome, meibomian gland dysfunction, glaucoma, history of ocular surgery) or recent periorbital cosmetic procedures; 4. Pregnancy, lactation, or planned pregnancy; 5. Use of photosensitizing agents or medications affecting wound healing; 6. Concomitant systemic diseases (such as uncontrolled diabetes mellitus, immune dysfunction, keloid predisposition, metallic implants, or cardiac pacemaker carriers).

Design outcomes

Primary

MeasureTime frame
Fitzpatrick Wrinkle and Elastosis Scale Evaluation;

Secondary

MeasureTime frame
Facial Laxity Rating Scale;Global Aesthetic Improvement;Antera3D measurement;VISIA imaging;Transepidermal water loss;

Countries

China

Contacts

Public ContactFenglin Zhuo

Beijing Friendship Hospital, Capital Medical University

zflsunny@hotmail.com+86 159 1089 5068

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026