NCT06117293

Brief Summary

Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

October 23, 2023

Last Update Submit

November 1, 2023

Conditions

Skin Texture DisorderPhotoagingWrinkleScarStretch MarkAcne VulgarisHair Loss

Outcome Measures

Primary Outcomes (1)

  • Photographic Assessment

    Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators

    90-day Follow-Up

Secondary Outcomes (9)

  • Safety Assessment

    up to 90 days post final treatment

  • Subject Satisfaction

    30-day and 90-day Follow-Up

  • Physician Satisfaction

    30-day and 90-day Follow-Up

  • Subject Clinical Global Aesthetic Improvement Scale

    30-day and 90-day Follow-Up

  • Physician Clinical Global Aesthetic Improvement Scale

    30-day and 90-day Follow-Up

  • +4 more secondary outcomes

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Device: Mosaic

Interventions

MosaicDEVICE

1550 Fractional Laser System

Treatment Arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking, Male or Female
  • Age 18 - 60 years old
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
  • OPTIONAL - Participants who are willing to undergo biopsies.

You may not qualify if:

  • Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure
  • A study participant must not be pregnant or have been pregnant in the last 3 months
  • A recent history of smoking (6 months)
  • Presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; connective tissue disease; radiation therapy; or chemotherapy)
  • Seizure disorder caused by bright light
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during, or after treatments
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E, or anti-inflammatories within 2 weeks prior to treatment
  • Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia)
  • A history of keloids
  • A history or evidence of poor wound healing
  • A history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study participation
  • Use of steroids within 2 weeks of study treatments
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Advanced Dermatology

Lincolnshire, Illinois, 60069, United States

RECRUITING

Lutronic

Billerica, Massachusetts, 01821, United States

RECRUITING

Dermatology & Skin Health

Peabody, Massachusetts, 01960, United States

RECRUITING

MeSH Terms

Conditions

CicatrixStriae DistensaeAcne VulgarisAlopecia

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsAcneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesHypotrichosisHair DiseasesPathological Conditions, Anatomical

Study Officials

  • Omar Ibrahimi

    Lutronic Medical Director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Denis

CONTACT

9788959206adenis@lutronic.com

Paul Cardiarelli

CONTACT

8012440058pcardarelli@lutronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 7, 2023

Study Start

February 21, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Plan will not be shared

Locations

US(3)