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

NCT05027282 | Completed Results FDA Device

• 1 other identifier: V01-CBT-401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment

  1 month post treatment, up to 5 months

Study Arms (1)

CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces

EXPERIMENTAL

Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.

Interventions

CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. DEVICE

CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.

CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• to 65 years of age.
• Written and oral informed consent must be obtained.
• No more than Mild (I) to Moderate (II) classification on Glogau Photodamage Scale.
• Fitzpatrick skin types I-VI.
• Fitzpatrick wrinkle \& elastosis scale class I-II, score 1-6 (fine wrinkles and mild elastosis).
• Ability to read, understand and sign the informed consent form.
• 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.

You may not qualify if:

• \. 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).
• \. 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.
• \. Known sensitivity to light or photosensitizing agents/medications are being taken.
• \. Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout course of the treatment.
• \. Use of retinoids less than 2 weeks prior to or during the study to completion.
• \. 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.
• \. Having had Botox injections, neurotoxin injections, or dermal fillers (such as collagen) within the past four months.
• \. Sunburn and/or recent sun exposure on the treatment area in the last 2 weeks.
• \. Subjects must agree to seek the advice of their medical doctor regarding any known or suspicious skin condition before laser treatment.
• \. Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.
• \. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Bausch Site 001

Dallas, Texas, 75225, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health Americas, Inc

susan.harris@bauschhealth.com

19083009920

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 24, 2021
• First Posted: August 30, 2021
• Study Start: October 27, 2021
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: November 22, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Locations

US (1)