Photoaging
Conditions
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.
Interventions
DEVICECLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.
CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces |
|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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.
Time frame: 3 months post treatment, up to 7 months
Population: Participants with 3 months of follow up were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces | Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment | 2.81 units on a scale | Standard Deviation 0.9 |
Secondary
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.
Time frame: 1 month post treatment, up to 5 months
Population: Participants with 1 month of follow up were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces | Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment | 2.59 units on a scale | Standard Deviation 0.8 |