Mosaic Laser Treatment for Skin and Hair Conditions

Recruiting at 2 trial locations

Overseen By Paul Cardiarelli

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: LUTRONIC Corporation

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

Disqualifiers: Pregnancy, Smoking, Heart failure, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Mosaic Laser Treatment for skin and hair conditions?

Research shows that advances in laser technology have made it possible to successfully treat various skin issues like unwanted hair, scars, and pigmented lesions with improved safety and effectiveness. Similar laser systems have been shown to achieve significant hair clearance and skin improvements, suggesting that the Mosaic Laser Treatment could be effective for these conditions as well. ^{1 2 3 4 5}

Is Mosaic Laser Treatment generally safe for skin and hair conditions?

Laser treatments, including those like the Mosaic Laser, are generally considered safe with quick healing times. Common mild side effects include redness and swelling, while rare long-term effects can include scarring or eye damage, but there are ways to manage these risks. ^{6 7 8 9 10}

How does the Mosaic Laser Treatment differ from other treatments for skin and hair conditions?

The Mosaic Laser Treatment is unique because it uses a 3D laser system that can target both skin and hair conditions, potentially offering a more comprehensive approach compared to other lasers that typically focus on either hair removal or specific skin issues like pigmentation or vascular lesions. ^{5 11 12 13 14}

Research Team

Omar Ibrahimi

Principal Investigator

Lutronic Medical Director

Eligibility Criteria

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

I am between 18 and 60 years old.

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

Exclusion Criteria

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

I have had blood clots in my veins before.

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

Trial Timeline

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

Treatment Details

Interventions

• Mosaic (Procedure)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

LUTRONIC Corporation

Lead Sponsor

Trials

15

Recruited

570+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lasers in dermatology: four decades of progress. [2007]

2. United States 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. [2012]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Lasers in dermatology. An overview of types and indications. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

[Photoepilation: state-of-the-art]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of outcome reporting in laser treatments for dermatological diseases. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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

10. New Zealand pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of Nd:YAG laser therapy for the treatment of verrucae: a literature review. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Evaluation of subject response following treatment for pigmentation or wrinkles using a diode laser. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[Pulsed color laser for treatment of benign, superficial vascular malformations]. [2007]

14. United States pubmed.ncbi.nlm.nih.gov

Use of a long-pulse alexandrite laser in the treatment of superficial pigmented lesions. [2007]