Skip to content

Comparison of the Efficacy and Adverse Effects of Fractional CO2 Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty

Comparison of the Efficacy and Adverse Effects of Fractional CO2 Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250325065152N2
Enrollment
24
Registered
2025-09-24
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Infraorbital Wrinkles Following Lower Blepharoplasty.

Interventions

Intervention 1: Patients in this intervention group will be treated with a Fractional CO2 Laser device (EdgeONE, 120-µm spot size). Before treatment, the lower eyelid area will be carefully cleansed a
to minimize pain and discomfort, a 5% lidocaine topical anesthetic cream will be applied under occlusion for 30–45 minutes and then completely removed. For ocular protection, either an intraocular met
in the case of itching or prolonged erythema, a short course (3–5 days) of 1% hydrocortisone cream will be recommended. One treatment session will initially be performed, and response and adverse even

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 30 to 65 years who have undergone lower blepharoplasty. Presence of visible and measurable wrinkles in the infraorbital area At least one month has passed since the lower blepharoplasty procedure. Good general health status with well-controlled systemic diseases and no active dermatological conditions. Provision of written informed consent acknowledging awareness of the benefits, risks, and potential side effects of the treatment.

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding history of allergy to fractional CO2 laser or mesotherapy agents Previous injectable, laser, or other skin rejuvenation treatments in the infraorbital area within the past six months; any cosmetic intervention that may influence the outcome assessment. Presence of skin infections, severe acne, or inflammatory skin diseases in the periorbital region; autoimmune disorders or uncontrolled diabetes. Lack of patient compliance with treatment sessions or follow-up visits; psychological or behavioral conditions affecting accurate information sharing or adherence to the study protocol.

Design outcomes

Primary

MeasureTime frame
The severity of lower eyelid wrinkles will be assessed using the standardized Lemperle Wrinkle Assessment Scale. This scale classifies the severity of each wrinkle into six grades from zero to five: 0: no wrinkle or completely smooth skin; 1: very superficial wrinkle barely visible at rest; 2: superficial but clearly visible wrinkle without significant depth; 3: moderate wrinkle, clearly visible with moderate depth; 4: deep wrinkle with well-defined edges but without skin overhang; 5: very deep wrinkle with marked skin overhang. Timepoint: Measurement of the severity of lower eyelid wrinkles will be performed before the intervention (baseline) and then at one month, three months, and six months after the intervention. Method of measurement: At each visit, standardized digital photographs of the lower eyelids of both eyes will be taken under fixed lighting, distance, and angle conditions. Two trained resident blinded evaluators will independently score these photographs using the standard Lemperle Wrinkle Assessment Scale from zero (no wrinkle) to five (very deep wrinkle), and the mean of the two scores will be recorded as the final value.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTaha Shahbazi

Tehran University of Medical Sciences

shahbazi.taha@yahoo.com+98 21 5288 8282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026