Laser Treatment for Facial and Neck Rejuvenation

Evaluation of the UltraClear Laser Workstation for the Treatment of Facial and Neck Rejuvenation and Skin Resurfacing Augmented With Mesenchymal Stem Cell Extract

To assess the efficacy, safety, and patient satisfaction associated with the treatment of the face and neck with the 2,910nm mid-infrared UltraClear Laser System using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin. Additionally, this study will assess the additive value of a post-treatment skincare regimen consisting of a serum and cream containing red deer umbilical cord lining mesenchymal stem cell conditioned media for faster healing and more robust rejuvenation.

Study Overview

• Status: Not yet recruiting
• Conditions: Face Rejuvenation; Neck Rejuvenation
• Intervention / Treatment: Other: CeraVe; Other: CeraVe and Calecim

Detailed Description

Subjects will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin of the face and neck. Subjects will be randomized to have one of two post-laser skincare regimens which will be applied to the face and neck following laser treatment.

All subjects will receive three (3) laser treatments to the face and neck using the UltraClear 2,910nm mid-infrared laser, performed 5 weeks ± 7 days apart.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Pacheco; Phone Number: 858-657-1004; Email: apacheco@clderm.com
• Study Contact Backup: Name: Freia Canals Cistero, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult males and females aged 18 to 75 years
• Fitzpatrick skin types I-V
• 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 examinations of face and neck and digital photographs performed of the face and neck
• Physician evaluator classifying the subject as moderate to severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale for the face and neck.
• The subject must be planning to undergo fractional ablative laser resurfacing to the face and neck and be willing to comply with study protocol and complete the entire course of the study.
• Subjects using any treatment skincare products (per investigator discretion) must discontinue use of these products before the start of participating in this clinical study and for the duration of the study.
• Male subjects with facial hair must be willing to shave the morning of the procedure.
• 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.

  1. 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.
  2. 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

Exclusion Criteria:

• 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
• Chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
• 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
• 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, diclofenac, or photodynamic therapy (PDT) to the face within the previous 4 weeks
• Subjects must not currently be taking isotretinoin (Accutane).
• 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 or systemic infection
• Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
• History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
• Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study
• Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma), atopic dermatitis, or immunologic abnormalities such as vitiligo.
• Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
• Presence of incompletely healed wound(s) in the treatment area
• Subjects who are on an immunosuppressant or have an autoimmune condition
• Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A CeraVe; Subjects will be given a skincare regimen consisting of CeraVe products to be applied to the face and neck following laser treatment.	Other: CeraVe; CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening; CeraVe lotion (CeraVe; New York, NY) to be used morning and evening, reapply as needed for dry skin; A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside
Sham Comparator: Group B Calecim; Subjects will be given a skincare regimen consisting of CeraVe products and Calecim products to be applied to the face and neck following laser treatment.	Other: CeraVe and Calecim; CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening; Calecim® Professional Serum (CellResearch Corporation; Singapore) to be used morning and evening; Calecim® Restorative Hydration Cream (CellResearch Corporation; Singapore) to be used morning and evening, reapply as needed for dry skin; A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale to assess change (blinded investigator)	Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale - FACE TO BE COMPLETED BY BLINDED INVESTIGATOR Class: Wrinkling Score Degree of Elastosis I Fine Wrinkles 1 -3 Mild II Fine to Moderate 4 -6 Moderate III Fine to Deep 7 -9 Severe	Baseline, Day 60, Day 250
Scientific Assessment Scale of Skin Quality to assess change (SASSQ) (blinded investigator)	SCIENTIFIC ASSESSMENT SCALE OF SKIN QUALITY (SASSQ) Elasticity: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Wrinkles: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Skin Surface Roughness: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pigmentation: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Erythema: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pore Size: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe	Baseline, Day 160, Day 250
Classification of Facial Wrinkles Assessment to assess change (blinded investigator)	Classification of Facial Wrinkles Assessment: Preauricular Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Cheek Folds: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Upper Lip Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme	Baseline, Day 160, Day 250
Neck Skin Crepiness/Laxity Grading Scale to assess change (blinded investigator)	Neck Skin Crepiness/Laxity Grading Scale: Score Classification Description 0 None No Loose Skin; Mild Mildly Loose Skin; Moderate Moderately Loose Skin; Severe Very Loose Skin; Extreme Prominent redundancy of loose skin	Baseline, Day 160, Day 250
Visia Skin Analysis to assess change	Visia Skin Analysis (insert percentage 1 - 100%) Description: Percentage: Brown Spots Pores Spots Porphyrin Red Areas Texture UV Spots Wrinkles	Baseline, Day 160, Day 250
Physician Global Aesthetic Improvement Scale to assess change (PGAIS) (blinded investigator)	Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description; Very Much Improved: Optimal cosmetic result in this subject.; Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.; Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated.; No Change: The appearance is essentially the same as the original condition.; Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or circle "Not Treated") FACE NECK not treated not treated	Day 160, Day 250
Percent Improvement Evaluation to assess change	Percent Improvement Evaluation: 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 160, Day 250

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of side effects and adverse events by Investigator to assess change	Evaluation of Side Effects and Adverse Events: Rating Description 0 NONE: Normal; TRACE: Barely visible and localized; MILD: Somewhat visible and diffuse; MODERATE: Visible and diffuse; SEVERE: Extremely visible and dense SCORES (write number under each treated area or check "Not Treated") Erythema: FACE NECK Edema: FACE NECK Hyperpigmentation: FACE NECK Blistering: FACE NECK Burn: FACE NECK Skin Crusting: FACE NECK	Baseline, Day 35, Day 70, Day 160, Day 250
Comfort Level Visual Analog Scale post laser procedure to assess change (completed by subject)	Comfort Level Visual Analog Scale post laser procedure (circle one) Face: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10 Neck: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10	Baseline, Day 35, Day 70
Subject Global Aesthetic Improvement Scale to assess change (SGAIS)	Subject Global Aesthetic Improvement Scale Assessment (SGAIS) Rating Description; Very Much Improved: Optimal cosmetic result in this subject.; Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.; Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated.; No Change: The appearance is essentially the same as the original condition.; Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or circle Not Treated) FACE NECK not treated not treated	Day 160, Day 250
Subject Satisfaction Questionnaire to assess change	Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you. Rating Description 0 Not satisfied; Somewhat satisfied; Satisfied; Very satisfied; Extremely Satisfied Scores (write a number to rate each treated area) FACE NECK not treated not treated	Day 160, Day 250

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Acclaro Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): April 3, 2023
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Sun Spots; Wrinkles; Laxity; Fine Lines; Facial Laxity
• Other Study ID Numbers: UC 16-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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.: Yes