Topical Carboxytherapy Paste Following Microneedling

ConditionSkin
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • CO2 gel mask

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Topical CarboxytherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Survey will be conducted at the initial clinic appointment prior to treatment.
2

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)

Time frame
A post-procedure survey will be conducted at the one-week post-procedure timepoint
3

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)

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.
4

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)

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 outcomes

1

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.

Time frame
A post-procedure survey will be conducted at the one-week post-procedure timepoint

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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