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Skin LaxityPhase 2NCT07462533

Assess Efficacy of a Nanodiamond Periprocedural Skin Care Regimen for Ablative Resurfacing

A Phase 2 study testing Pavise Serum and Co2/Er:YAG in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the efficacy and tolerability of Pavise Extracellular Matrix Restore (ECMR), compared with standard acute post-operative care, when used as the primary occlusive treatment immediately following ablative CO₂ and Er:YAG facial laser resurfacing to support wound healing. Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Skin Laxity
What is being tested?
Pavise Serum and Co2/Er:YAG
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
No sites listed yet
Study dates
20 Mar 2026to 30 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males or females in good general health age 35-70 years of age.
  • Subjects with score Moderate to Severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale (Appendix E)
  • Subjects with score Moderate to Severe facial photodamage as assessed by the Modified Griffth's Scale (Appendix F)
  • Fitzpatrick skin types I-III.
  • Must be willing to give and sign Informed Consent Form, Photography Release Form and HIPAA Form.
  • The subject must be planning to undergo ablative CO2 and Er:YAG laser resurfacing to the face and willing to comply with study dosing and complete the entire course of the study.
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  • Subjects using any skin care products (per physician-investigator discretion) must discontinue use of these products 14 days before treatment and throughout the duration of the study. Subjects will only use the products they are instructed to use by the investigator.
  • Male subjects with facial hair must be willing to shave the morning of the procedure
  • Female patients will be either of non-childbearing potential defined as: Having no uterus or no menses for at least 12 months. Women of childbearing potential must agree to use an effective method of birth control during the study, such as:
  • Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
  • Intrauterine coil
  • Bilateral tubal ligation
  • Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
  • Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
  • Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with an Un-Vasectomized partner).
  • Negative urine pregnancy test results at Baseline prior to procedure (if applicable

Who cannot join

  • Pregnant, planning to become pregnant during the course of the study, or breastfeeding.
  • Prescence of an active bacterial, fungal, or viral infection in the treatment area.
  • Significant history or current evidence of a medical, psychological or other condition that, in the investigator's opinion, would preclude enrollment into the study.
  • Use of any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
  • Receipt of a chemical peel, any systemic steroids, a non-ablative laser, ablative laser, microfocused ultrasound, light or radio frequency treatment, deep chemical peel, or dermabrasion on their face within 6 months prior to study enrollment.
  • Receipt of a microdermabrasion (light or medium skin peel) treatment to the face within 30 days prior to enrollment and unwillingness to refrain from use for the duration of the study period.
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  • Excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days prior to enrollment.
  • Prior treatment with a systemic retinoid within the past 3 months (e.g., Accutane®, Roche Dermatologics).
  • History of keloids or hypertrophic scars.
  • Known allergy to Valacyclovir or Fluconazole or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-amino benzoic acid), or other local anesthetics of the amide or ester family sedation medication.
  • Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments.
  • History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the physician-investigator
  • Inability to comply with all study protocol restrictions and visits.
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
  • History of non-compliance with clinical research protocols.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

West Dermatology Research Center contact

858-657-1004

research@clderm.com

Andrea Pacheco contact

apacheco@clderm.com

About this study

Official title: A Prospective, Randomized, Open-label Study Evaluating the Efficacy of a Nanodiamond Periprocedural Skin Care Regimen for Ablative Resurfacing

The primary objective of this study is to evaluate the efficacy and tolerability of Pavise Extracellular Matrix Restore (ECMR), compared with standard acute post-operative care, when used as the primary occlusive treatment immediately following ablative CO₂ and Er:YAG facial laser resurfacing to support wound healing.

Read the detailed description

8 patients total will receive an ablative CO₂ and Er:YAG facial laser resurfacing treatment to the face. Each will be assigned to either Group A Control or Group B Active and given a skincare regimen to follow post procedure. Patients will return for follow up visits at Day 1 post procedure, Day 4 post procedure, Day 7 post procedure, 14 days post procedure and 3 months post procedure for 2D photography and assessments.

Conditions
Skin Laxity
Being tested
Pavise Serum, Sham Comparator, Co2/Er:YAG
Keywords
face, rejuvenation, wrinkles, texture
Medical subject headings
Cutis Laxa, Facies

What participants receive

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

  • Pavise SerumDrug

    Pavise ECMR (extracellular matrix restore) serum regimen combined with laser treatment

  • Sham ComparatorDrug

    Vehicle serum regimen combined with laser treatment

  • Co2/Er:YAGDevice

    Ablative laser resurfacing treatment

Study groups in NCT07462533
Study groupRoleWhat they receive
Group ASham comparator4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive Pavise ECMR (extracellular matrix restore) serum for post treatment care.
Receives: Drug: Pavise Serum; Device: Co2/Er:YAG
Group BActive comparator4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive vehicle serum for post treatment care.
Receives: Drug: Sham Comparator; Device: Co2/Er:YAG

What is being measured

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

  1. Investigator Evaluation of Erythema, Edema, Exudation and Crusting

    Circle one for Perioral Area:

    Erythema:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Edema:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Crusting:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Exudation:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Circle one for Periorbital Area:

    Erythema:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Edema:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Crusting:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Exudation:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Measured: Day of procedure, post day 1, post day 4, post day 7, post day 14

Secondary outcomes (6)

  1. Fitzpatrick Goldman Classification of Wrinkling and Degree of Elastosis Scale

    Circle One:

    1. Fine wrinkles with mild elastosis
    2. Fine to moderate wrinkles with moderate elastosis
    3. Fine to deep wrinkles with severe elastosis

    Measured: Screening, Baseline, 3 month visit

  2. Tolerability Assessment by the Investigator

    Circle One:

    Erythema 0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Edema:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Dryness:

    0= None

    1. Mild
    2. Moderate
    3. Pronounced
    4. Severe

    Measured: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit

  3. Subject Self Assessment Questionnaire

    Rate from 0-10 for each of the following questions where 0 is no pain and 10 is excruciating pain

    1. Pain
    2. Itching
    3. Tightness
    4. Oozing
    5. Crusting

    Measured: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit

  4. Subject Healing Questionnaire

    Circle One

    1. Study product supported my healing post procedure Strongly Agree Disagree Neutral Agree Strongly Agree
    2. Study product reduces irritation Strongly Agree Disagree Neutral Agree Strongly Agree
    3. Study product was not irritating or painful to apply Strongly Agree Disagree Neutral Agree Strongly Agree
    4. I was satisfied with my recovery/progression Strongly Agree Disagree Neutral Agree Strongly Agree

    Measured: post day 1, post day 4, post day 7, post day 14

  5. Subject End of Study Self Assessment Questionnaire

    Circle One:

    Please rate your improvement 0= Worse

    1. No Improvement
    2. Mild Improvement
    3. Moderate Improvement
    4. Pronounced Improvement

    Measured: 3 month visit

  6. Investigator Global Improvement Assessment

    Circle One: ]

    Please rate subjects improvement 0= Worse

    1. No Improvement
    2. Mild Improvement
    3. Moderate Improvement
    4. Pronounced Improvement

    Measured: 3 month visit

Timeline

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

  1. First posted10 Mar 2026
  2. Study start20 Mar 2026 (estimated)
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Aug 2026 (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 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
All subjects will receive on ablative laser facial treatment then be assigned to one of two groups for post treatment regimen.
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462533
Sponsor's protocol ID
Pavise-IIT-2026
Status last verified
Mar 2026
First submitted
5 Mar 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pavise Serum and Co2/Er:YAG in people with Skin Laxity, 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 15 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact West Dermatology Research Center (858-657-1004, research@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Evaluation of Erythema, Edema, Exudation and Crusting (time frame: Day of procedure, post day 1, post day 4, post day 7, post day 14). 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 NCT07462533.

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 10 Mar 2026.

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