Fractional Laser Drug Delivery of a Local Anesthetic

NCT05734248 | Completed

• 1 other identifier: 00000010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the clinical efficacy of fractional CO2 laser-assisted delivery of a topically applied anesthetic to the perceived pain during filler injection.

Conditions

Aging; Face; Atrophy

Outcome Measures

Primary Outcomes (1)

• Pain-Anesthetic effect of AFL

  Pain evaluation of the injected filler, with a VAS (0 to 10)

  immediately after the intervention/procedure

Study Arms (2)

Intervention group

EXPERIMENTAL

This test region (right or left cheek) will be pretreated with a fractional carbon dioxide laser (ablative fractional laser; AFL) with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse at t0 in a operator- and subject- blinded fashion. A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed. Interventions: AFL Device: AFL Drug: anesthetic mixture cream

Procedure: Facial filler injection

Control

PLACEBO COMPARATOR

A pass with the same fractional carbon dioxide laser with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse will be given at the area right adjacent to the test region on the other to the intervention cheek ("sham AFL") at t0 in a operator- and subject-blinded fashion. A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed. Interventions: sham AFL Device: sham AFL Drug: anesthetic mixture cream

Procedure: Facial filler injection

Interventions

Facial filler injection PROCEDURE

Hyaluronic acid will be injected on the cheek, based on the aesthetic evaluation of the face.

Also known as: hyaluronic acid injection

Control; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patient is willing and able to give written informed consent
• Patient asks for facial filler injections (hyaluronic acid) to improve the facial aesthetic/ aging signs

You may not qualify if:

• History of keloid or hypertrophic scar formation or complicated wound healing
• Presence of any active skin disease
• Known allergy to local anesthesia
• Pregnancy or lactation
• Incompetency to understand what the procedure involves
• Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra)
• Current treatment with systemic analgesics or other medication that can influence pain sensation
• Current treatment with anticoagulants

Sponsors & Collaborators

• University Hospital, Ioannina: lead

Study Sites (2)

Plastic Surgery Department

Ioannina, Greece

Location

Swan Clinic

Ioannina, Greece

Location

MeSH Terms

Conditions

Facies; Atrophy

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor of Plastic Surgery

Model Details: Split-face model

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 17, 2023
• Study Start: February 6, 2023
• Primary Completion: October 10, 2023
• Study Completion: December 5, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

GR (2)