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

March 5, 2026 updated by: Goldman, Butterwick, Fitzpatrick and Groff

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Informed Consent 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-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:

    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:

  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 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.
  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 investigational research study.
  15. History of non-compliance with clinical research protocols.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Pavise ECMR (extracellular matrix restore) serum regimen combined with laser treatment
Device: Co2/Er:YAG
Ablative laser resurfacing treatment
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
Vehicle serum regimen combined with laser treatment
Device: Co2/Er:YAG
Ablative laser resurfacing treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitzpatrick Goldman Classification of Wrinkling and Degree of Elastosis Scale
Time Frame: Screening, Baseline, 3 month visit

Circle One:

  1. Fine wrinkles with mild elastosis
  2. Fine to moderate wrinkles with moderate elastosis
  3. Fine to deep wrinkles with severe elastosis
Screening, Baseline, 3 month visit
Tolerability Assessment by the Investigator
Time Frame: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit

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
Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit
Subject Self Assessment Questionnaire
Time Frame: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit

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
Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit
Subject Healing Questionnaire
Time Frame: post day 1, post day 4, post day 7, post day 14

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
post day 1, post day 4, post day 7, post day 14
Subject End of Study Self Assessment Questionnaire
Time Frame: 3 month visit

Circle One:

Please rate your improvement 0= Worse

  1. No Improvement
  2. Mild Improvement
  3. Moderate Improvement
  4. Pronounced Improvement
3 month visit
Investigator Global Improvement Assessment
Time Frame: 3 month visit

Circle One: ]

Please rate subjects improvement 0= Worse

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Collaborators

Bai Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pavise-IIT-2026

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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