About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
CO2 gel mask
DrugCO2 gel mask will be applied to one half of the face for 40 minutes after microneedling
Treatment groups
Trial outcomes
Primary outcomes
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).
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)
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)
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)
Secondary outcomes
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.
Locations
Sponsors and contacts
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