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

NCT ID: NCT05027282

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2022-11-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Varsha Bhatt

Role: STUDY_DIRECTOR

Bausch Health

Locations

Bausch Site 001

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-CBT-401

Identifier Type: -

Identifier Source: org_study_id