ClinicalTrials.gg
Not yet recruitingNCT07462533Updated Mar 10, 2026

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

A Phase 2 interventional study of Pavise Serum and Sham Comparator in Skin Laxity, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Skin Laxity

Keywords

  • face
  • rejuvenation
  • wrinkles
  • texture
03

In context

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males or females in good general health age 35-70 years of age.
  2. 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)
  3. Subjects with score Moderate to Severe facial photodamage as assessed by the Modified Griffth's Scale (Appendix F)
  4. Fitzpatrick skin types I-III.
  5. Must be willing to give and sign Form, Photography Release Form and HIPAA Form.
  6. 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.
  7. 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.
  8. Male subjects with facial hair must be willing to shave the morning of the procedure
  9. Female patients will be either of non- 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 during the study, such as:

    1. Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
    2. Intrauterine coil
    3. Bilateral tubal ligation
    4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
    5. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
    6. Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with an Un-Vasectomized partner).
    7. Negative urine pregnancy test results at Baseline prior to procedure (if applicable

Exclusion criteria

Exclusion Criteria:

  1. Pregnant, planning to become pregnant during the course of the study, or breastfeeding.
  2. Prescence of an active bacterial, fungal, or viral infection in the treatment area.
  3. Significant history or current evidence of a medical, psychological or other condition that, in the investigator's opinion, would preclude enrollment into the study.
  4. 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.
  5. Receipt of a chemical peel, any systemic , 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.
  6. 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.
  7. 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.
  8. Prior treatment with a systemic retinoid within the past 3 months (e.g., Accutane®, Roche Dermatologics).
  9. History of keloids or hypertrophic scars.
  10. 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.
  11. Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments.
  12. 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
  13. Inability to comply with all study protocol restrictions and visits.
  14. Current participation or participation within 30 days prior to the start of this study in a drug or other research study.
  15. History of non-compliance with clinical research protocols.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Sham comparator
    Group A

    4 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.

    Drug: Pavise Serum · Device: Co2/Er:YAG

  • Active comparator
    Group B

    4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive vehicle serum for post treatment care.

    Drug: Sham Comparator · Device: Co2/Er:YAG

Interventions

  • DrugPavise Serum

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

  • DrugSham Comparator

    Vehicle serum regimen combined with laser treatment

  • DeviceCo2/Er:YAG

    Ablative laser resurfacing treatment

06

What researchers measure

Primary outcomes

  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

    Time frame: Day of procedure, post day 1, post day 4, post day 7, post day 14

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 month visit

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2026; primary completion for Jul 2026, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 10, 2026
StartEst.
Mar 20, 2026
Primary completionEst.
Jul 30, 2026
CompletionEst.
Aug 30, 2026
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07462533
Lead sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
Bai Biosciences
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

West Dermatology Research Center
Contact
research@clderm.com
858-657-1004
Andrea Pacheco
Contact
apacheco@clderm.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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