Topical Carboxytherapy Paste Following Microneedling

Effect of Topical Carboxytherapy Paste Following Microneedling

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin
• Intervention / Treatment: Drug: CO2 gel mask

Detailed Description

This exploratory study will be a prospectively collected split-face study to evaluate the effects of topical carboxytherapy following cosmetic microneedling. Traditional carboxytherapy treatments involve administering carbon dioxide (CO2) to the skin through direct injection or with minimally invasive devices. Carboxytherapy has been well studied and is thought to increase tissue oxygenation by causing localized decreases in pH, likened to an artificial Bohr effect, which results in greater peripheral blood flow, thus aiding in angiogenesis and vascular perfusion. Reported benefits of carboxytherapy include stimulation of collagen production, reduction of skin discoloration, and scar quality improvement. Comparative studies suggest that carboxytherapy devices are at least as effective as microneedling in the treatment of acne scarring. Topical carboxytherapy, in the form of an applied gel paste, is a newer development. Carboxytherapy paste carries non-gaseous CO2 and has a transdermal mechanism of action, and is advantageous over previous formulations due to the completely non-invasive nature of administration. In healthy patients, topical carboxytherapy led to no adverse events and was shown to increase signal intensity on dynamic MRI, indicating greater blood flow. Topical carboxytherapy also facilitated faster wound healing of chronic diabetic ulcers. Due to its novelty, few studies have investigated how topical carboxytherapy can be used as an adjuvant treatment in the field of facial plastic and reconstructive surgery. However, one split face study saw improvement in blinded investigator ratings of dryness, erythema, edema, crusting, and percentage healing on the side which received topical carboxytherapy after nanofractional laser treatment.

The investigators want to investigate the efficacy of topical carboxytherapy at mitigating the common inflammatory effects of microneedling. Given microneedling is an increasingly popular treatment, many patients may benefit from an adjuvant treatment that minimizes postprocedural downtime related to its adverse side effects. Topical carboxytherapy is commercially available but has yet to receive FDA approval. This will be an exploratory, singlearm trial using CO2 Lift Gel mask (Lumisque, Weston, FL), which is a topically applied mixture of magnesium carbonate and gluconolactone gel. Outcomes will include both independent physician assessments of skin appearance and subjective patient-reported measures (on day of procedure following paste application and at one week post-procedure timepoint). These will be collected based on patient survey, provider assessments, and a blinded third-party physician analysis of postprocedural photographs. 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. The investigators will compare outcomes in the treated and non-treated side of the patient's face before and immediately after completed application of carboxytherapy paste as well as at one-week post-procedure. The investigators hypothesize that the treated side of the face will demonstrate decreased severity of outcome measures and experience shorter duration of adverse effects related to microneedling.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amy Wang; Phone Number: 2818859243; Email: amy.wang@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Carboxytherapy; 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; CO2 gel mask will be applied to one half of the face for 40 minutes after microneedling; Other Names: topical carboxytherapy; carboxytherapy paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience	Using 5-point Likert scales (0=Strongly Disagree 1=Disagree 2=Neutral 3=Agree 4=Strongly Agree), patients will answer a survey regarding their experience with using topical carboxytherapy.	A post-procedure survey will be conducted at the one-week post-procedure timepoint

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: microneedling; carboxytherapy
• Other Study ID Numbers: 251400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No