Mosaic Laser Treatment for Skin and Hair Conditions

Recruiting at 2 trial locations

Overseen By Paul Cardiarelli

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: LUTRONIC Corporation

Must not be taking: Antiplatelets, Anticoagulants, Steroids, others

Disqualifiers: Pregnancy, Smoking, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 39

Duration: Varies

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment called Mosaic to evaluate its safety and effectiveness in improving skin tone and texture, reducing wrinkles and scars, treating acne, and addressing hair loss. Participants will undergo up to five treatment sessions and follow-up visits. Ideal candidates are non-smokers aged 18-60 who haven't recently undergone surgical or cosmetic procedures on the treatment area and don't have active skin diseases or conditions affecting healing. As an unphased trial, this study offers participants the chance to contribute to innovative research and potentially benefit from cutting-edge treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like antiplatelets, anticoagulants, thrombolytics, vitamin E, anti-inflammatories, and steroids at least 2 weeks before participating. If you are on these medications, you will need to stop them before joining the study.

What prior data suggests that the Mosaic Ultra 1550nm system is safe for treating skin and hair conditions?

Research shows that the Mosaic Ultra 1550nm system, a type of laser treatment, improves skin tone, texture, and conditions like wrinkles and scars. Similar systems, such as the Mosaic 3D, have tightened or resurfaced soft tissue in skin treatments. These lasers have been used before for skin issues.

Although specific details on side effects or safety from these studies are not available, the use of these lasers in skin treatments suggests they are generally safe. Since this treatment is not new and is already used for certain skin procedures, it provides some confidence in its safety. However, like any medical treatment, there might be risks or side effects, so discussing participation with healthcare providers is important before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mosaic laser treatment is unique because it uses advanced laser technology to target both skin and hair conditions with precision. Unlike traditional treatments that might rely on topical creams or invasive procedures, this laser method can be fine-tuned to treat specific areas without affecting the surrounding healthy tissue. Researchers are excited about the Mosaic laser because it promises faster recovery times and potentially fewer side effects, making it a cutting-edge option compared to existing therapies.

What evidence suggests that the Mosaic Laser Treatment is effective for skin and hair conditions?

Research has shown that the Mosaic Ultra 1550nm laser system, which participants in this trial will receive, can effectively improve skin tone and texture. Studies have found that this laser treatment reduces wrinkles, scars, and acne. Mosaic 3D, another aspect of the treatment, rejuvenates the skin by addressing sagging, uneven texture, and sun damage. The treatment uses laser energy to target and thicken soft tissue, aiding in skin resurfacing. Early evidence suggests it may also help with stretch marks and sun damage. Overall, the Mosaic laser shows promise in treating various skin and hair conditions, promoting a healthier and more youthful skin appearance. ^{1 2 4 6 7}

Who Is on the Research Team?

Omar Ibrahimi

Principal Investigator

Lutronic Medical Director

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

OPTIONAL - Participants who are willing to undergo biopsies

Understands and accepts the obligation not to undergo any other procedures in the areas to be treated

I can follow all study rules and visit schedules.

Exclusion Criteria

A study participant must not be pregnant or have been pregnant in the last 3 months

Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia)

I have had blood clots in my veins before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will be treated up to 5 times with the Mosaic Ultra 1550nm system

Varies

Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

30-day and 90-day follow-up visits

Biopsy and Inflammatory Response Assessment

Biopsies taken from healthy tissue to evaluate histological effects and inflammatory response

21 days post treatment

Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post

What Are the Treatments Tested in This Trial?

Interventions

• Mosaic

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 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.

Mosaic is already approved in United States for the following indications:

Approved in United States as Mosaic 3D Laser System for:

• dermatological procedures requiring the coagulation of soft tissue
• fractional skin resurfacing procedures

Who Is Running the Clinical Trial?

LUTRONIC Corporation

Lead Sponsor

Trials

15

Recruited

570+

Published Research Related to This Trial

Cutaneous lasers and energy modalities like radiofrequency and ultrasound are generally safe, with rapid healing times and mild, self-resolving side effects such as redness and swelling lasting only hours to days.

While most adverse events are mild, there are some medium- to long-term risks, including changes in skin pigmentation and scarring, but these are rare and can often be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. Alam, M., Warycha, M.[2022]

In a study involving 101 volunteers with various skin types, the new intense pulse light (IPL) technology demonstrated significant efficacy in treating conditions like hair removal, acne, and vascular lesions, with no serious adverse events reported.

The treatment was particularly effective for hair removal, with all patients achieving significant clearance, and those with facial rosacea responding the fastest, highlighting the importance of tailoring treatment settings to individual skin types and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy. Belenky, I., Tagger, C., Bingham, A.[2015]

Laser therapy using a 1064-nm neodymium-doped yttrium aluminum garnet laser is an effective treatment for verrucae, offering a targeted approach with minimal risks of pigmentation changes, especially beneficial for individuals with darker skin types.

Traditional treatments for verrucae often result in high recurrence rates and scarring, making laser therapy a promising alternative that addresses both cosmetic concerns and functional discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Nd:YAG laser therapy for the treatment of verrucae: a literature review. Hsu, VM., Aldahan, AS., Tsatalis, JP., et al.[2018]

Recent advancements in laser technology have significantly improved the treatment of various skin conditions, including vascular and pigmented lesions, tattoos, scars, and unwanted hair, leading to better clinical outcomes.

The increased demand for laser surgery is attributed to its effectiveness and low risk of adverse effects, providing both patients and dermatologists with more treatment options and enhanced safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers in dermatology: four decades of progress. Tanzi, EL., Lupton, JR., Alster, TS.[2007]

The flash lamp-excited dye laser is an effective and painless treatment for various benign vascular skin lesions, including port-wine stains and spider angiomas.

This laser operates on the principle of selective photothermolysis, which minimizes damage to surrounding tissue and results in extremely rare complications like scarring or skin texture changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulsed color laser for treatment of benign, superficial vascular malformations]. Gosepath, K., Mann, W.[2007]

Skin disorders are the most common adverse reactions to drugs, and this journal section provides updated information on these reactions from both new and established medications.

The case reports are sourced from comprehensive databases like the WHO Adverse Drug Reactions database, ensuring that the information is reliable and assessed for seriousness according to FDA standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous drug reaction case reports: from the world literature. [2018]

Adverse drug events (ADEs) affect over 2 million Americans annually, leading to significant safety concerns and financial costs exceeding $170 billion each year in the U.S.

Dermatologists and dermatopathologists face potential legal implications due to ADEs, as many drugs removed from the market are linked to product liability lawsuits, which could involve claims of negligence and consumer protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety: implications for the dermatologist and dermatopathologist. Restaino, JM.[2019]

Recent advancements in laser technology have significantly improved the ability to effectively treat various skin conditions, including vascular and pigmented lesions, tattoos, scars, and unwanted hair.

The increased demand for laser surgery is attributed to its effectiveness and low risk of adverse effects, highlighting the growing confidence in laser treatments for skin issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers in dermatology. An overview of types and indications. Alster, TS., Lupton, JR.[2018]

The article reviews various laser systems used for permanent hair removal, including ruby, alexandrite, diode, Nd:YAG lasers, and intense pulsed light (IPL) systems, highlighting their advantages and disadvantages.

It also discusses new methods for treating depigmented and therapy-resistant hair, as well as addressing hair removal in female patients with polycystic ovary syndrome, indicating advancements in personalized dermatological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photoepilation: state-of-the-art]. Gansel, RW.[2021]

The variable long-pulse alexandrite laser effectively clears solar lentigines (dark spots on the skin) in a single treatment session, showing significant efficacy especially in patients with darker lesions.

Shorter pulse widths and treatments without epidermal cooling were found to enhance the effectiveness of the laser, allowing for better clearance of the lesions with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a long-pulse alexandrite laser in the treatment of superficial pigmented lesions. Trafeli, JP., Kwan, JM., Meehan, KJ., et al.[2007]

A retrospective analysis of 44 adult subjects treated with a diode laser system showed significant improvement in pigmentation and wrinkles, with a mean clearance of 2.50 for pigmentation and a mean improvement of 0.46 for wrinkles, indicating the efficacy of the treatment.

The diode laser treatments were well-tolerated by patients, with all immediate side effects resolving within 48 hours, highlighting the safety and minimal downtime associated with this noninvasive aesthetic procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of subject response following treatment for pigmentation or wrinkles using a diode laser. Koren, A., Isman, G., Friedman, O., et al.[2021]

In a study involving subjects with Fitzpatrick skin types II-V, three different laser firing modes for hair removal showed high efficacy, with mean hair clearance percentages of 83% for the alexandrite laser, and 81% and 86% for the multiplexed pulse combinations.

All treatment methods had minimal side effects, indicating that the multiplexed laser pulses are as safe as the traditional alexandrite laser while providing comparable effectiveness in removing unwanted axillary hair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral axilla hair removal comparing a single wavelength alexandrite laser with combined multiplexed alexandrite and Nd:YAG laser treatment from a single laser platform. Bernstein, EF., Basilavecchio, L., Plugis, J.[2012]

A systematic review of 150 studies on laser treatments for skin disorders revealed significant variability in how outcomes are reported, highlighting the need for standardized outcome measures to improve the comparison and interpretation of results.

The review identified 105 different outcomes categorized into eight domains, but found a lack of focus on life impact areas such as patient satisfaction (23%), quality of life (3%), and psychological functioning (1%), indicating important aspects of treatment effectiveness are often overlooked.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcome reporting in laser treatments for dermatological diseases. Fransen, F., Tio, DCKS., Prinsen, CAC., et al.[2020]

A retrospective analysis of the MAUDE database from 2004 to 2014 revealed 9 deaths and 215 injury events linked to electromechanical morcellation, highlighting significant risks associated with this surgical device.

The analysis found that 27 cases involved the morcellation of previously undiagnosed cancers, with 8 of the 9 deaths related to cancer morcellation, indicating a critical safety concern in using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. Naumann, RW., Brown, J.[2019]

Citations

1. withpower.com withpower.com/trial/phase-skin-texture-disorder-1-2023-6366d

Mosaic Laser Treatment for Skin and Hair Conditions 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.

2. cynosure.com cynosure.com/product/mosaic-3d/

Mosaic 3D Fractional Laser Mosaic 3D is indicated for the following: dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06117293

Safety and Efficacy Evaluation of the Mosaic Ultra Device Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, ...

4. trialx.com trialx.com/clinical-trials/listings/248904/safety-and-efficacy-evaluation-of-the-mosaic-ultra-device/

Safety and Efficacy Evaluation of the Mosaic Ultra Device Safety and Efficacy Evaluation of the Mosaic Ultra Device ; Conditions. Skin Texture Disorder, Photoaging, Wrinkle, Scar, Stretch Mark ; Clinical ...

5. neweramedicalaesthetics.com neweramedicalaesthetics.com/services/laser-energy/mosaic-3d-by-lutronic/

Mosaic 3D by Lutronic in Vienna, VA Mosaic 3D is designed for those seeking advanced skin rejuvenation to address concerns such as sagging skin, fine lines, uneven texture, sun damage, and age ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233550.pdf

January 2, 2024 Lutronic Aesthetic Kevin O'connell VP Global ... The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06117293/safety-and-efficacy-evaluation-of-the-mosaic-ultra-device?state=MA&city=Billerica

Safety and Efficacy Evaluation of the Mosaic Ultra Device Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, ...