Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment

A Prospective Study Evaluating the Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment.

This is a prospective study of up to 30 subjects designed to assess the safety and effectiveness of a non-ablative fractional laser combination wavelength treatment for general resurfacing of photoaged skin. All study subjects will be treated on the whole face with the CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. Subjects will be treated with a consecutive series of four (4) treatments spaced 1 month apart, along with follow-up study visits at one (1) and three (3) months after final treatment.

Study Overview

• Status: Completed
• Conditions: Photoaging
• Intervention / Treatment: Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75225
      • Bausch Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female.
2. 18 to 65 years of age.
3. Written and oral informed consent must be obtained.
4. No more than Mild (I) to Moderate (II) classification on Glogau Photodamage Scale.
5. Fitzpatrick skin types I-VI.
6. Fitzpatrick wrinkle & elastosis scale class I-II, score 1-6 (fine wrinkles and mild elastosis).
7. Ability to read, understand and sign the informed consent form.
8. Agree not to take any new medications (unless prescribed by the study investigator) or undergo any other procedures that may potentially treat photodamaged skin (any other aesthetic treatments) during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding, or planning to become pregnant during the study. 2 History of any type of allergic reaction to lidocaine. 3. Recent and/or active localized or systemic infections. 4. Diagnosis/possibility of actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g. skin cancer, active infections, cold sores, open wounds, rashes, burns, inflammation eczema, psoriasis).

5. Predisposition to keloid formation or excessive scarring. 6. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, scleroderma, and/or systemic infections.

7. Known sensitivity to light or photosensitizing agents/medications are being taken.

8. Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout course of the treatment.

9. Use of retinoids less than 2 weeks prior to or during the study to completion.

10. Individuals undergoing Accutane™ treatment or drugs in a similar class. 11. Having skin that is still recovering from a cosmetic procedure: such as a chemical peel, or mechanical peel, or laser resurfacing within the previous 6 months.

12. Having had Botox injections, neurotoxin injections, or dermal fillers (such as collagen) within the past four months.

13. Sunburn and/or recent sun exposure on the treatment area in the last 2 weeks.

14. Subjects must agree to seek the advice of their medical doctor regarding any known or suspicious skin condition before laser treatment.

15. Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.

16. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces	Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.; CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment	Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement.	3 months post treatment, up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment	Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement.	1 month post treatment, up to 5 months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Varsha Bhatt, Bausch Health

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: V01-CBT-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No