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Not yet recruiting NCT07431541

Topical Carboxytherapy Paste Following Microneedling

Phase I / Phase II Interventional Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CO2 gel mask.
Who it may be relevant to
Registry conditions: Skin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Topical Carboxytherapy Paste Following Microneedling

Overview

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.

Interventions

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

Primary outcome measures

  • Patient Reported Outcome Measures (Before Treatment) [Time frame: Survey will be conducted at the initial clinic appointment prior to treatment.]
  • Patient Reported Outcome Measures (After Treatment) [Time frame: A post-procedure survey will be conducted at the one-week post-procedure timepoint]
  • Photo Assessment CEA [Time frame: 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 [Time frame: 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 (1)
  • Patient Experience [Time frame: A post-procedure survey will be conducted at the one-week post-procedure timepoint]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07431541 · 251400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗