Trials Sponsors Conditions Drugs Pricing

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

Interventions

Facial filler injectionProcedure

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

Also known as: hyaluronic acid injection

ControlIntervention group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years
Patient is willing and able to give written informed consent

Sponsors & Collaborators

University Hospital, Ioannina
Otherlead

Study Sites (2)

Plastic Surgery Department

Ioannina, Greece

Swan Clinic

Ioannina, Greece

MeSH Terms

Conditions

FaciesAtrophy

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Enrollment

25 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 17, 2023

Study Start

February 6, 2023

Fractional Laser Drug Delivery of a Local Anesthetic

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Intervention group

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Intervention group

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations