Topical Carboxytherapy Paste Following Microneedling

NCT07431541 | Not Yet Recruiting Phase 1

• 1 other identifier: 251400
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Topical carboxytherapy refers to a gel paste that carries non-gaseous carbon dioxide (CO2). It is applied similarly to a face mask. Topical carboxytherapy has been shown to increase local blood flow and can help with wound healing. Few studies have researched how topical carboxytherapy can be used to aid skin rejuvenation in the field of facial plastic and reconstructive surgery. The goal of this study is to evaluate how topical carboxytherapy can improve skin healing after microneedling. Common temporary side effects of microneedling include redness and swelling, sometimes lasting up to a week post-procedure. If topical carboxytherapy reduces downtime related to side effects of microneedling, the investigators may offer this treatment to more microneedling patients in the future.

Conditions

Skin

Keywords

microneedling; carboxytherapy

Outcome Measures

Primary Outcomes (4)

• Patient Reported Outcome Measures (Before Treatment)

  We will evaluate responses prior to microneedling with carboxytherapy. Conditions such as skin dullness, uneven texture or acne scarring, and hyperpigmentation or dark spots will be assessed. Respones will be based on a 5-point scale (0=No signs of issue 1=Almost clear of issue 2=Mild issue 3=Moderate issue 4= Severe issue). A separate question regarding satisfaction with skin quality will be measured using Likert scale (0=Very dissatisfied 1=Somewhat dissatisfied 2=Neutral 3=Somewhat satisfied 4=Very satisfied).

  Survey will be conducted at the initial clinic appointment prior to treatment.

• Patient Reported Outcome Measures (After Treatment)

  We will evaluate responses following microneedling with carboxytherapy. Patients will be asked to separately rate the treated and untreated sides of the face. Conditions such as skin dullness, uneven texture or acne scarring, and hyperpigmentation or dark spots will be assessed. Patient responses will be based on 5-point scale (0=No signs of issue 1=Almost clear of issue 2=Mild issue 3=Moderate issue 4= Severe issue). A separate question regarding satisfaction with skin quality will be measured using Likert scale (0=Very dissatisfied 1=Somewhat dissatisfied 2=Neutral 3=Somewhat satisfied 4=Very satisfied). Additionally, experience of common side effects of microneedling such as swelling, facial redness, discomfort or sensitivity will be assessed as follows: (0=No signs of unwanted side effect 1=Almost clear of unwanted side effect 2=Mild side effect 3=Moderate side effect 4=Severe side effect)

  A post-procedure survey will be conducted at the one-week post-procedure timepoint

• Photo Assessment CEA

  Trained third-party reviewers will evaluate photos of treated and untreated sides of patient faces using validated 5-point scales for skin including the clinician erythema assessment (CEA). CEA: (0 = Clear skin with no signs of erythema 1 = Almost clear, slight redness 2 = Mild erythema, definite redness 3 = Moderate erythema, marked redness 4 = Severe erythema, fiery redness)

  Photos are taken before, immediately following microneedling and carboxytherapy treatment, and one-week post-procedure. Photo analysis will occur retrospectively following conclusion of data collection.

• Photo Assessment IGA

  Trained third-party reviewers will evaluate photos of treated and untreated sides of patient faces using validated 5-point investigator global assessment (IGA) scales for edema, hyperpigmentation and skin texture. Edema IGA: (0 = no edema 1 = slight edema 2 = mild edema 3 = moderate edema 4 = severe edema) Hyperpigmentation IGA: (0 = None, clear of hyperpigmentation and no difference with surrounding skin 1 = Almost clear of hyperpigmentation, barely visible relative to surrounding skin 2 = Mild, but noticeable hyperpigmentation relative to surrounding skin 3 = Moderate, marked changes in pigmentation relative to surrounding skin 4 = Severe, maximal changes in pigmentation) Skin Texture IGA: (0 = Smooth, homogenous texture throughout 1 = Almost smooth, slight texture 2 = Mild texture, easily recognizeable, less than half the area is involved 3 = Moderate texture, more than half the area is involved 4 = Severe texture, high degree of textural irregularity, entire face involved)

  Photos are taken before, immediately following microneedling and carboxytherapy treatment, and one-week post-procedure. Photo analysis will occur retrospectively following conclusion of data collection.

Secondary Outcomes (1)

• Patient Experience

  A post-procedure survey will be conducted at the one-week post-procedure timepoint

Study Arms (1)

Topical Carboxytherapy

EXPERIMENTAL

This is a split-face study (i.e.only one half of the face will receive carboxytherapy paste) where patients will serve as their own controls. Following microneedling, topical carboxytherapy will be applied to either the right (even MRN) or left (odd MRN) side of the face only for 40 minutes.

Drug: CO2 gel mask

Interventions

CO2 gel mask DRUG

CO2 gel mask will be applied to one half of the face for 40 minutes after microneedling

Also known as: topical carboxytherapy, carboxytherapy paste

Topical Carboxytherapy

Eligibility Criteria

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

You may qualify if:

• English-speaking adults at least 18 years of age who elect to undergo microneedling for facial aging.

You may not qualify if:

• Age under 18
• Pregnant patients
• Patients with other known medical conditions which affect facial cosmesis
• Patients who have recently undergone surgery to the facial region or minimally invasive facial procedures within the past month

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Central Study Contacts

Amy Wang

CONTACT

2818859243; amy.wang@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the split-face nature of the study (i.e. only one half of the face will receive carboxytherapy paste), patients will serve as their own controls. Third-party reviewers will be blinded to the side of face which received topical carboxytherapy during photo assessment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share