Laser Treatment to Improve Skin Quality

NCT05595525 | Unknown FDA Device

• 1 other identifier: Pico-Skin-Quality-2022-09
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.

Conditions

Skin Quality

Keywords

wrinkles; fine lines; sun spots; laxity; facial laxity

Outcome Measures

Primary Outcomes (3)

• Scientific Assessment Scale of Skin Quality (SASSQ) to assess change

  Scientific Assessment Scale of Skin Quality (SASSQ) (circle one) Elasticity 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Wrinkles 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Skin Surface Roughness 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Lentigines/ Pigmentation 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Erythema 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Pore Size 0- Fine 1- Small 2- Moderate 3- Large 4- Very Large

  Screening, Baseline, Day 28, Day 56, Day 140

• Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change

  Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Left Facial Half Right Facial Half Not Treated Not Treated

  Day 28, Day 56, Day 140

• Percent improvement of skin quality by blinded investigator to assess change

  Blinded Investigator Percent Improvement Evaluation - Left Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) Blinded Investigator Percent Improvement Evaluation - Right Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)

  Day 28, Day 56, Day 140

Secondary Outcomes (4)

• Subject Global Aesthetic Improvement Scale (SGAIS)

  Day 28, Day 56, Day 140

• Subject Satisfaction Questionnaire

  Day 140

• Comfort level visual analog scale post-procedure by subjects

  Baseline, Day 28, Day 56

• Evaluation of side effects and adverse effects by investigators

  Baseline, Day 28, Day 56, Day 140

Study Arms (2)

Group A = right side face treated with 1064nm and left with 755nm

EXPERIMENTAL

subject will have their right half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, left half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half.

Device: 1064NM pico Laser; Device: 755NM pico Laser

Group B = left side face treated with 1064nm and right with 755nm

EXPERIMENTAL

subject will have their left half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, right half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half.

Device: 1064NM pico Laser; Device: 755NM pico Laser

Interventions

1064NM pico Laser DEVICE

There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.

Also known as: Candela 1064NM Laser

Group A = right side face treated with 1064nm and left with 755nm; Group B = left side face treated with 1064nm and right with 755nm

755NM pico Laser DEVICE

There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.

Also known as: Cynosure 755NM Laser

Group A = right side face treated with 1064nm and left with 755nm; Group B = left side face treated with 1064nm and right with 755nm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 18 to 65 years
• Fitzpatrick skin types I-VI
• Subjects in good general health based on investigator's judgment and medical history
• Must be willing to give and sign an informed consent form and photographic release form
• Willingness to have facial exams and digital photographs performed of the face
• Physician evaluator classifying the subject as moderate or severe in all categories of the Scientific Assessment Scale of Skin Quality (SASSQ): elasticity, wrinkles, skin surface roughness, lentigines/pigmentation, erythema, blemishes, and pore size
• No change in topical skin care regimen for duration of study
• Must be willing to maintain usual sun exposure
• Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
• Negative urine pregnancy test result at the time of study entry (if applicable)
• For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
• A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
• Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
• Must be willing to comply with study treatments and complete the entire course of the study

You may not qualify if:

• Mesotherapy, dermal fillers, biostimulatory injectables, and/or fat grafting in the treatment area during the 12-month period before study treatment
• Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
• Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
• Chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
• Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 12-month period before the study treatment
• Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5- fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks
• Creams/cosmeceuticals and/or home therapies to prevent or treat photodamage, uneven skin pigmentation, excessive erythema (redness), fine lines/wrinkles, skin laxity and/or pore size during the 4-week period before study treatment
• Subjects with scarring in the treatment areas
• Subjects with tattoos or permanent implants in the treatment areas
• Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
• Skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
• History of keloid or hypertrophic scarring
• Subjects with an active bacterial, viral, or fungal infection of the treatment areas
• Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Andrea Pacheco

CONTACT

8586571004; apacheco@clderm.com

Sherif Mikhail, MD

CONTACT

8586571004; smikhail@westderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the blinded investigator will complete the Scientific Assessment Scale of Skin Quality (SASSQ). , the blinded investigator will complete the Physician Global Aesthetic Improvement Scale (PGAIS) and percent improvement evaluation. Percent Improvement Evaluation by Blinded investigator . Subjects are blinded to which side receives which laser
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: subjects will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10