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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05027282
Recruitment Status : Completed
First Posted : August 30, 2021
Results First Posted : November 21, 2023
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Photoaging Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study Evaluating the Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Actual Study Start Date : October 27, 2021
Actual Primary Completion Date : November 18, 2022
Actual Study Completion Date : November 18, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment [ Time Frame: 3 months post treatment, up to 7 months ]
    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.


Secondary Outcome Measures :
  1. Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment [ Time Frame: 1 month post treatment, up to 5 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05027282


Locations
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United States, Texas
Bausch Site 001
Dallas, Texas, United States, 75225
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Varsha Bhatt Bausch Health
  Study Documents (Full-Text)

Documents provided by Bausch Health Americas, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] September 13, 2021

More Information
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT05027282    
Other Study ID Numbers: V01-CBT-401
First Posted: August 30, 2021    Key Record Dates
Results First Posted: November 21, 2023
Last Update Posted: November 22, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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