Mosaic Laser Treatment for Skin and Hair Conditions
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byOmar Ibrahimi
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.
12345Is 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.
678910How 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.
511121314Eligibility 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
+2 more
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)
+14 more
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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dermatology & Skin HealthPeabody, MA
Advanced DermatologyLincolnshire, IL
LutronicBillerica, MA
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Who Is Running the Clinical Trial?
LUTRONIC CorporationLead Sponsor
References
Lasers in dermatology: four decades of progress. [2007]Advances in laser technology have progressed so rapidly during the past decade that successful treatment of many cutaneous concerns and congenital defects, including vascular and pigmented lesions, tattoos, scars, and unwanted hair-can be achieved. The demand for laser surgery has increased substantially by patients and dermatologists alike as a result of the relative ease with which many of these lesions can be removed, combined with a low incidence of adverse postoperative sequelae. Refinements in laser technology and technique have provided patients and practitioners with more therapeutic choices and improved clinical results. In this review, the currently available laser systems with cutaneous applications are outlined, with primary focus placed on recent advancements and modifications in laser technology that have greatly expanded the cutaneous laser surgeon's armamentarium and improved overall treatment efficacy and safety.
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]This study compares the efficacy, safety, and side-effect profile of three different firing modes in a single laser emitting both dual-wavelength multiplexed laser pulses and single-wavelength pulses for removing unwanted axillary hair in subjects with Fitzpatrick skin types II-V.
Lasers in dermatology. An overview of types and indications. [2018]Advances in laser technology have been so marked over the past two decades that successful eradication of many cutaneous pathologies and congenital defects, including vascular and pigmented lesions, tattoos, scars, and unwanted hair, can now be fully realized. Because of the relative ease with which many of these lesions can be removed, coupled with a low incidence of adverse postoperative sequelae, demand for laser surgery has increased substantially. In this review, the currently available laser systems with cutaneous application are outlined, with special reference to recent advancements and modifications in laser technology that have greatly expanded the laser surgeon's armamentarium and improved upon overall treatment efficacy.
Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy. [2015]The widely used intense pulse light (IPL) technology was first commercially launched to the medical market in 1994 and similar to lasers, is based on the basic principle of selective photothermolysis. The main conflict during treatments with light-based technologies is between safety and efficacy of the treatment. The aim of this study was to evaluate new IPL technology, which integrates three different pulse configurations, with specific attention on the safety and efficacy of the treatment. 101 volunteers (with Fitzpatrick skin types I-VI) were treated as follows: 9 patients underwent 8 bi-weekly acne clearance treatments, 51 patients underwent 6-12 hair removal treatments, 11 patients were treated for general skin rejuvenation, 15 patients were treated for pigmentation lesions, and 15 patients were treated for vascular lesions. No serious adverse events were recorded. All patients that were treated for hair removal achieved significant hair clearance. The patients with facial rosacea responded the fastest to the treatment. Eight of nine patients that were treated for acne clearance achieved significant reduction in acne appearance. The results represented in this study support the approach that when taking into consideration both efficacy of the treatment and safety of the patients, the system should be "flexible" enough to allow exact treatment settings profile for each patient, according to their skin type and the symptom's biophysical characteristics. <
[Photoepilation: state-of-the-art]. [2021]The field of dermatological laser medicine consists of four main areas: therapy for blood vessels, therapy for pigmented lesions, ablation of tissue, and photoepilation. The first tests were carried out in 1993, and since 1996 there has been a growing demand for "permanent hair removal." This strong demand and the rapid development of devices call for extensive knowledge in terms of current technical innovation or affirmation of proven procedures. This article gives a general survey of the different systems that can be used for "permanent hair removal" [ruby laser, alexandrite laser, diode, Nd:YAG laser, so-called intense pulsed light (IPL) systems, and combined radio frequency/IPL systems], including their inherent advantages and disadvantages. Physical and biological aspects necessary for photoepilation are pointed out. Furthermore, we emphasize new methods concerning removal of depigmented and therapy-resistant hair, as well as the treatment of female patients with polycystic ovary syndrome.
A systematic review of outcome reporting in laser treatments for dermatological diseases. [2020]The standardization of outcome reporting is crucial for interpretation and comparison of studies related to laser treatment of skin disorders. In collaboration with the Cochrane Skin-Core Outcome Set Initiative (CS-COUSIN), a procedure has been proposed to find consensus on the most important generic outcome domains (what to measure) for implementation in the international Laser TrEAtment in Dermatology (LEAD) registry. As the first step in the development of a generic outcome set for the LEAD registry, we undertook a systematic review to identify outcomes, outcome measurement instruments, methods and definitions reported in recently published literature of laser treatments for skin disorders. A systematic search was conducted and generated a total of 707 papers. We assessed 150 studies including all types of studies involving laser treatments for the skin. Two researchers independently extracted the type, definition and frequency of all outcomes and used outcome measurement instruments. We identified 105 verbatim outcomes that were categorized into eight domains recommended by the COMET framework: appearance, long-term effects, physician and patient-reported physical signs, satisfaction, health-related quality of life, psychological functioning and adverse events. Heterogeneity in outcome reporting (e.g. categories and outcome measurement instruments) was high, and definitions were insufficiently reported. There was a clear under representation of life impact domains, including satisfaction (23%) quality of life (3%) and psychological functioning (1%). Outcome reporting concerning laser treatments for the skin is heterogeneous. Standardized outcomes are needed for improving evidence synthesis. Results of this review will be used in the next step to reach consensus between stakeholders on the outcome domains to be implemented in the LEAD registry.
Complications of lasers and light treatments. [2022]Cutaneous lasers and lights, and also more novel cutaneous energy modalities like radiofrequency and ultrasound, are in general very safe interventions with an associated rapid healing time. Posttreatment sequelae are usually mild and spontaneously resolving, with erythema and edema lasting hours to days. More troublesome, less common short-term adverse events include urticaria, erosions, crusting, ecchymoses, blistering, and infection. Medium-term adverse events include hyperpigmentation, hypopigmentation, a line of demarcation, burns, textural imperfections, and delayed reepithelialization. Long-term to permanent adverse events, which are fortunately rare, include indentation, scar, and ocular damage. With few exceptions, there are management strategies for avoiding laser adverse events, and, if they do occur, for mitigating their impact.
Drug safety: implications for the dermatologist and dermatopathologist. [2019]The recent decades have seen a plethora of drugs removed from the world-wide market place over safety concerns and reported adverse events. In some cases, drugs with significant reports of adverse drugs events (ADEs) have remained on the market with either a Black Box warning, strict prescribing guidelines, or both. It has been reported that more than 2,000,000 Americans are harmed by ADEs each year. The financial costs associated with ADEs are staggering with over $170 billion spent annually in the United States as a result of ADEs. The implications for the dermatologist and dermatopathologist are daunting for the skin is the organ most frequently affected by ADEs. Many cases of drugs removed from the market are preceded by the filing of one or more product liability lawsuits. This means the dermatologist could be brought under claims of negligence, strict liability, breach of warranty, and consumer protection claims. The potential implications for the dermatologist or dermatopathologist are discussed along with an introduction to the legal process, which comes into play with the filing of the product liability lawsuit.
Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. [2019]To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database.
Cutaneous drug reaction case reports: from the world literature. [2018]Skin disorders are the most common adverse reactions attributed to drugs. Any skin disorder can be imitated, induced or aggravated by drugs. To help you keep up-to-date with the very latest skin reactions occurring with both new and established drugs, this section of the journal brings you information selected from the adverse drug reaction alerting service Reactions Weekly. The following case reports are selected from the very latest to be published in the world dermatology literature. Any claim of a first report has been verified by a search of AdisBase (a proprietary database of Adis International) and Medline. In addition, the World Health Organization (WHO) Adverse Drug Reactions database is also searched. This database, maintained by the Uppsala Monitoring Centre in Sweden, is the largest and most comprehensive adverse drug reaction source in the world, with information obtained from National Centers of around 70 affiliate countries. Each case report is assessed for seriousness using the FDA MedWatch definition of serious (patient outcome is: death; life-threatening; hospitalization; disability; congenital anomaly; or requires intervention to prevent permanent impairment or damage).
Efficacy of Nd:YAG laser therapy for the treatment of verrucae: a literature review. [2018]Verrucae are benign epithelial proliferations, characteristically 1-20 mm in diameter, caused by human papilloma virus (HPV) infection occurring on the skin and mucosa (Photomed Laser Surg 33(6):338-42, 2015; Lasers Med Sci 29(3):1111-6, 2014). Prevalence of verrucae is 5-20% in children and young adults with peak incidence reported during teenage years (Lasers Med Sci 29(3):1111-6, 2014; J Am Acad Dermatol 22(4):547-66, 1990; J Korean Med Sci 24(5):889-93, 2009). Patients often express significant displeasure with quality of life due to this cosmetic insecurity, as well as functional problems and physical discomfort when they occur on palms of hands and soles of feet. Traditional therapeutic options for warts, such as topical salicyclic acid, topical imiquimod, bleomycin injections, cryotherapy, surgical excision, and electrocautery, have proven somewhat effective but often lead to high recurrence rates or scarring (Photomed Laser Surg 33(6):338-42, 2015). Laser therapy offers an alternative solution by employing selective tissue destruction with minimal risks. We performed a broad literature search in PubMed to obtain all available published articles that studied the treatment of verrucae on the skin with 1064-nm neodymium-doped yttrium aluminum garnet laser. This laser is specifically suited for verruca treatment due to its deeply penetrating 1064-nm wavelength and relatively low risk of pigmentation changes in dark skin types (Photomed Laser Surg 33(6):338-42, 2015). Laser therapy is effective in the treatment of verrucae and has enabled clinicians to provide direct, targeted treatment of warts.
Evaluation of subject response following treatment for pigmentation or wrinkles using a diode laser. [2021]Pulsed diode array laser systems are utilized extensively for various aesthetic indications such as removal of unwanted hair, treatment of vascular and pigmented lesions, and wrinkle reduction.
[Pulsed color laser for treatment of benign, superficial vascular malformations]. [2007]The flash lamp-excited dye laser is ideal for treating benign superficial vascular cutaneous lesions. Port-wine stains, telangiectases, spider angiomas, or hemangiomas may be treated without pain. If used properly, complications such as skin texture changes, hypopigmentation, and scarring are extremely rare. The flash lamp-excited dye laser works on the principle of selective photothermolysis, which allows selective damage to the target vessel without affecting surrounding tissue. Lesions like xanthelasma palpebrarum, keloid scars, and warts may also be treated by the flash lamp-excited dye laser. This study presents the results of treatment with this laser in our patients.
Use of a long-pulse alexandrite laser in the treatment of superficial pigmented lesions. [2007]Although the alexandrite 755-nm-wavelength laser is effective in the treatment of unwanted hair, there are no published studies gauging the efficacy of the variable long-pulse alexandrite laser in the treatment of superficial pigmented lesions.