What is the mechanism of action of this treatment?

The most common treatments for skin texture disorders, such as laser therapies including the Mosaic Ultra 1550nm system, work by stimulating collagen production and remodeling the skin's structure. These treatments use targeted laser energy to create controlled micro-injuries in the skin, which triggers the body's natural healing process. This process leads to the production of new collagen and elastin fibers, essential proteins that provide skin with strength and elasticity. For patients with skin texture disorders, this is crucial as it helps to smooth out irregularities, reduce the appearance of scars and wrinkles, and improve overall skin tone and texture, leading to a more youthful and even complexion.

What side effects are associated with this type of intervention?

Common side effects of laser therapies for skin texture disorders, such as those similar to the Mosaic Ultra 1550nm system, include temporary redness, swelling, and discomfort at the treatment site. Less common but more severe side effects can include blistering, changes in skin pigmentation (either hyperpigmentation or hypopigmentation), and scarring. These side effects are typically mild and self-resolving, but proper post-treatment care is crucial to minimize risks.

What prior FDA approvals exist?

The FDA has approved several treatments for skin texture disorders that are similar to the Mosaic Ultra 1550nm system. These include various laser therapies such as fractional CO2 lasers and non-ablative lasers like the Fraxel laser, which are designed to stimulate collagen production and improve skin texture. These treatments are commonly used for facial rejuvenation, photoaging, wrinkles, and scars. Additionally, intense pulsed light (IPL) therapy has also been approved for improving skin texture and treating photodamage.

What other types of research exist?

Promising alternatives to the Mosaic Ultra 1550nm system for skin texture disorders include: 1) Picosecond lasers, which offer precise treatment with minimal downtime and are effective for various skin conditions including acne scars and pigmentation. 2) Intense Pulsed Light (IPL) therapy, which can treat a range of skin issues with minimal purpura and downtime. 3) Poly-L-lactic acid (Sculptra) injections, which stimulate collagen production and are effective for improving skin texture and volume. 4) Daylight photodynamic therapy, which is effective for actinic keratoses and offers a convenient, nearly painless alternative to conventional photodynamic therapy.

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Procedure

Mosaic Laser Treatment for Skin and Hair Conditions

N/A

Recruiting

Led By Omar Ibrahimi

Research Sponsored by LUTRONIC Corporation

Eligibility Criteria Checklist

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

Must have

Age 18 - 60 years old

Be between 18 and 65 years old

Must not have

A history of thrombophlebitis

Use of steroids within 2 weeks of study treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediate post treatment, 4 days post, 14 days post, 21 days post

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a laser treatment called the Mosaic Ultra 1550nm system. It aims to help people with skin problems like wrinkles, scars, and acne. The laser works by boosting the skin's natural healing process to make it look smoother and younger. The 1550 nm laser device has been previously studied for its safety and effectiveness in improving wrinkles, pigmentation, and skin texture.

Who is the study for?

This trial is for non-smoking adults aged 18-60 who have skin issues like uneven tone, wrinkles, scars, stretch marks, acne or hair loss. They must not plan other skin treatments during the study and should be able to follow all requirements including clinic visits. Pregnant individuals or those with certain medical conditions or recent procedures are excluded.

What is being tested?

The Mosaic Ultra Device using a 1550nm system is being tested for its ability to improve skin appearance and treat various conditions such as photoaging and hair loss. Participants will undergo treatment sessions with this device to assess its safety and effectiveness.

What are the potential side effects?

While the specific side effects are not listed here, potential risks may include discomfort at the treatment site, redness, swelling, bruising, changes in pigmentation, scarring or infection. These depend on individual reactions to the device.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 60 years old.

Exclusion Criteria

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

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I have had blood clots in my veins before.

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I have not taken steroids in the last 2 weeks.

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I have a history of heart failure.

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I have a history of wounds healing poorly.

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I have a pacemaker, defibrillator, metal pins, or prosthetic joints near the treatment area.

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I have seizures triggered by bright lights.

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I have had serious infections recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediate post treatment, 4 days post, 14 days post, 21 days post

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediate post treatment, 4 days post, 14 days post, 21 days post

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post treatment, 4 days post, 14 days post, 21 days post for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Photographic Assessment

Secondary study objectives

Coagulation Zone Measurements

Dermal Inflammatory Response

Epidermal Inflammatory Response

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Subjects will be treated up to 5 times with a 30- and 90-day post final-treatment follow-up. Subjects may be asked to participate in an elective biopsy collected from normal skin simultaneously.

0 / 8Eligibility 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

The most common treatments for skin texture disorders, such as laser therapies including the Mosaic Ultra 1550nm system, work by stimulating collagen production and remodeling the skin's structure. These treatments use targeted laser energy to create controlled micro-injuries in the skin, which triggers the body's natural healing process. This process leads to the production of new collagen and elastin fibers, essential proteins that provide skin with strength and elasticity. For patients with skin texture disorders, this is crucial as it helps to smooth out irregularities, reduce the appearance of scars and wrinkles, and improve overall skin tone and texture, leading to a more youthful and even complexion.

Treatment of nevus Ota: combined skin abrasion and carbon dioxide snow method.Physician-patient communication and patient-reported outcomes in the actinic keratosis treatment adherence initiative (AK-TRAIN): a multicenter, prospective, real-life study of treatment satisfaction, quality of life and adherence to topical field-directed therapy for the treatment of actinic keratosis in Italy.A prospective study of safety and efficacy of combination therapy with bipolar radiofrequency-based intense pulsed light, infrared light, and diode laser in Chinese subjects with photoaged skin.