What side effects are associated with this type of intervention?

Common side effects of Carbon Dioxide (CO2) laser treatments include redness, swelling, and discomfort at the treatment site. Patients may also experience prolonged erythema (redness), hyperpigmentation, or hypopigmentation. In some cases, there can be a risk of infection, scarring, and delayed healing. The trial involving Autologous Cell Suspension aims to mitigate these side effects and promote faster healing.

What prior FDA approvals exist?

The FDA has approved various treatments to enhance healing and reduce side effects following Carbon Dioxide (CO2) laser therapy. One notable approach under investigation is the use of autologous cell suspension, which involves using the patient's own cells to promote faster healing and minimize adverse effects. This method is being studied for its potential to improve recovery times and outcomes post-CO2 laser treatment. While specific FDA approvals for autologous cell suspension in this context are still emerging, the focus remains on innovative therapies that leverage the body's natural healing processes.

What other types of research exist?

Promising alternatives to Autologous Cell Suspension for CO2 laser patients include Low-Level Laser Therapy (LLLT) and Platelet-Rich Plasma (PRP) therapy. LLLT has shown efficacy in promoting hair growth and healing in various dermatological conditions. PRP therapy, which involves using a concentration of a patient's own platelets to accelerate healing, has been effective in treating androgenetic alopecia and chronic wounds. Both therapies have demonstrated potential in enhancing tissue repair and reducing recovery time.

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RECELL for Carbon Dioxide Laser Recovery

Phase 4

Waitlist Available

Led By Joseph Molnar, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing facelift with perioral CO2 laser treatment

Be older than 18 years old

Must not have

Prior perioral CO2 laser resurfacing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if using a special laser on the face followed by applying a solution made from the patient's own cells can reduce side effects and speed up healing. The treatment is aimed at people with severe skin aging. The laser removes damaged skin, and the cell solution helps the skin heal faster and better. Lasers have been used for decades in skin treatments, with advancements leading to reduced side effects and improved healing times.

Who is the study for?

This trial is for adults over 18 with a light skin tone (Fitzpatrick Score 1 or 2) who are getting a facelift and CO2 laser treatment around the mouth. It's not for those who've had perioral CO2 laser resurfacing before or have allergies to the ReCell system components.

What is being tested?

The study tests if using ReCell, which involves applying your own cells after they're prepared through special processes, can reduce side effects from CO2 laser treatments and speed up healing of the skin.

What are the potential side effects?

While specific side effects aren't listed, generally procedures like this could cause redness, swelling, sensitivity at the application site, infection risk or an allergic reaction to the preparation used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am getting a facelift and CO2 laser treatment around my mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had CO2 laser treatment around my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Skin Sensitivity Scores - Burning

Change in Skin Sensitivity Scores - Itching

Change in Skin Sensitivity Scores - Redness

+3 more

Secondary study objectives

Healing Within 2 Weeks Post-op

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Right receives ReCell (A)Experimental Treatment1 Intervention

Right perioral area of face receives ReCell/ Left receives saline

Group II: Left receives ReCell (B)Experimental Treatment1 Intervention

Left perioral area of face receives ReCell/ Right receives saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ReCell

2015

Completed Phase 4

~30

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Carbon Dioxide (CO2) lasers work by emitting a concentrated beam of light that vaporizes the water in skin cells, leading to the removal of thin layers of skin with high precision. This process stimulates collagen production and skin remodeling, which is beneficial for treating various skin conditions. However, CO2 laser treatments can cause side effects such as prolonged healing times and skin irritation. Autologous cell suspension, which involves applying a patient's own cells prepared through enzymatic and mechanical methods, can enhance healing and reduce these side effects by promoting faster re-epithelialization and reducing inflammation. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their expectations regarding recovery and outcomes.

A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause.Retrospective Matched Case-Control Study on the Use of CO2 Laser for the Treatment of Nonhealing Diabetic Foot Ulcers: The DULCIS-2 (Diabetic ULcer, CO2 Laser, and Infections) Study.[Treatment of Hailey-Hailey disease with carbon dioxide laser vaporization].