NCT07431541

Topical Carboxytherapy Paste Following Microneedling

Effect of Topical Carboxytherapy Paste Following Microneedling

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Skin

Interventions

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

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-02-24
• Last updated: 2026-04-14