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Face RejuvenationNCT05808842

Laser Treatment for Facial and Neck Rejuvenation

A study testing CeraVe and CeraVe and Calecim in people with Face Rejuvenation and Neck Rejuvenation, run by Goldman, Butterwick, Fitzpatrick and Groff.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Face Rejuvenation, Neck Rejuvenation
What is being tested?
CeraVe and CeraVe and Calecim
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
No sites listed yet
Study dates
3 Apr 2023to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

No sites are listed yet.

Andrea Pacheco contact

858-657-1004

apacheco@clderm.com

Freia Canals Cistero, RN contact

About this study

Official title: 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.

Read the 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.

Being tested
CeraVe, CeraVe and Calecim
Keywords
Wrinkles, Fine Lines, Sun Spots, Laxity, Facial Laxity
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeraVeOther

    • 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

  • CeraVe and CalecimOther

    • 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
Study groups in NCT05808842
Study groupRoleWhat they receive
Group A CeraVeActive comparatorSubjects will be given a skincare regimen consisting of CeraVe products to be applied to the face and neck following laser treatment.
Receives: Other: CeraVe
Group B CalecimSham comparatorSubjects will be given a skincare regimen consisting of CeraVe products and Calecim products to be applied to the face and neck following laser treatment.
Receives: Other: CeraVe and Calecim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, Day 60, Day 250

  2. 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

    Measured: Baseline, Day 160, Day 250

  3. 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

    Measured: Baseline, Day 160, Day 250

  4. 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

    1. Mild Mildly Loose Skin
    2. Moderate Moderately Loose Skin
    3. Severe Very Loose Skin
    4. Extreme Prominent redundancy of loose skin

    Measured: Baseline, Day 160, Day 250

  5. 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

    Measured: Baseline, Day 160, Day 250

  6. Physician Global Aesthetic Improvement Scale to assess change (PGAIS) (blinded investigator)

    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 circle "Not Treated")

    FACE NECK

    not treated not treated

    Measured: Day 160, Day 250

  7. 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%)

    Measured: Day 160, Day 250

Secondary outcomes (4)

  1. Evaluation of side effects and adverse events by Investigator to assess change

    Evaluation of Side Effects and Adverse Events:

    Rating Description 0 NONE: Normal

    1. TRACE: Barely visible and localized
    2. MILD: Somewhat visible and diffuse
    3. MODERATE: Visible and diffuse
    4. 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

    Measured: Baseline, Day 35, Day 70, Day 160, Day 250

  2. 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

    Measured: Baseline, Day 35, Day 70

  3. Subject Global Aesthetic Improvement Scale to assess change (SGAIS)

    Subject Global Aesthetic Improvement Scale Assessment (SGAIS)

    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 circle Not Treated)

    FACE NECK

    not treated not treated

    Measured: Day 160, Day 250

  4. 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

    1. Somewhat satisfied
    2. Satisfied
    3. Very satisfied
    4. Extremely Satisfied

    Scores (write a number to rate each treated area) FACE NECK

    not treated not treated

    Measured: Day 160, Day 250

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start3 Apr 2023 (estimated)
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion28 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808842
Sponsor's protocol ID
UC 16-2022
Status last verified
Apr 2023
First submitted
20 Mar 2023
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing CeraVe and CeraVe and Calecim in people with Face Rejuvenation and Neck Rejuvenation, run by Goldman, Butterwick, Fitzpatrick and Groff.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale to assess change (blinded investigator) (time frame: Baseline, Day 60, Day 250). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05808842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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