NCT05695807

Brief Summary

To evaluate the efficacy of CO2 versus fractional CO2 laser versus platelet rich plasma in treatment of atrophic scars using clinical assessment and ultrasonography

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 13, 2023

Last Update Submit

January 13, 2023

Conditions

Atrophic Scar

Outcome Measures

Primary Outcomes (1)

  • Modified Vancouver score

    12 weeks

Study Arms (3)

Carboxytherapy

EXPERIMENTAL

Device

Device: Carboxytherapy

Fractional CO2 laser

ACTIVE COMPARATOR

Device

Device: Carboxytherapy

Platelet rich plasma

ACTIVE COMPARATOR

platelet rich plasma

Device: Carboxytherapy

Interventions

CarboxytherapyDEVICE

Device generating CO2 gas

CarboxytherapyFractional CO2 laserPlatelet rich plasma

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • traumatic and surgical scar

You may not qualify if:

  • active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01