Skin
Conditions
Keywords
microneedling, carboxytherapy
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.
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
DRUGCO2 gel mask
CO2 gel mask will be applied to one half of the face for 40 minutes after microneedling
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measures (Before Treatment) | Survey will be conducted at the initial clinic appointment prior to 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). |
| Patient Reported Outcome Measures (After Treatment) | A post-procedure survey will be conducted at the one-week post-procedure timepoint | 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) |
| Photo Assessment CEA | 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. | 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) |
| Photo Assessment IGA | 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. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience | A post-procedure survey will be conducted at the one-week post-procedure timepoint | 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. |
Outcome results
None listed