Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation

NCT06366503 | Completed FDA Device

• 1 other identifier: RS-2023-05
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device. A total of 22 healthy female subjects completed the study.

Conditions

Photoaging; Wrinkle; Skin Laxity

Keywords

post-procedure; Fractional Ablative CO2 Laser

Outcome Measures

Primary Outcomes (3)

• Investigator Tolerability

  The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in score or lack of significant change post product application, Day 1 (24 hours), Day 3, Day 5, Day 7, and Day 14 in comparison to baseline (immediately post-procedure) indicates tolerability / safety of the test material. A four-point scale will be used with a lower score indicating a better outcome: 0 = None 1. = Mild 2. = Moderate 3. = Severe

  14 days

• Incidence of Adverse Events

  The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediately post-procedure and throughout the length of the study.

  14-days

• Subject Tolerability

  The subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in score or lack of significant change post product application, Day 1 (24 hours), Day 3, Day 5, Day 7, and Day 14 in comparison to baseline (immediately post-procedure) indicates tolerability / safety of the test material. A four-point scale will be used with a lower score indicating a better outcome: 0 = None 1. = Mild 2. = Moderate 3. = Severe

  14 days

Secondary Outcomes (1)

• Self-Assessment Questionnaire

  14 days

Study Arms (2)

Split-Face Application of Active (Experimental)

EXPERIMENTAL

Active (Experimental) Post-Procedure Cream Dosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants. Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply face (including upper eyelid), jawline, and neck. The product was labelled with Right or Left depending on split-face randomization. Study duration: 28 days. Active Post-Procedure Cream duration 14-days.

Procedure: Fractional Ablative CO2 Laser; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen

Split-Face Application of Comparator

ACTIVE COMPARATOR

COMPARATOR: Dosage Form: anhydrous formulation. Comparator Anhydrous Formulation Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply on the face (including upper eyelid), jawline, and neck. The product was labelled with Right or Left depending on split-face randomization. Study duration: 28 days. Comparator duration 14-days.

Procedure: Fractional Ablative CO2 Laser; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen; Other: Basic Ointment

Interventions

Fractional Ablative CO2 Laser PROCEDURE

A fractional ablative DEKA SmartXide Tetra CO2 laser treatment was performed after a 14-day washout period. Subjects were numbed for 1 hour prior to procedure with topical numbing cream (lidocaine 23%, tetracaine 7%). The global face was treated with a single pass. Treatment parameters include power 20 W, spacing 500 um (13% density), Dwell time 1200 us DEKA pulse mode, spray mode on.

Also known as: DEKA SmartXide Tetra CO2 laser treatment

Split-Face Application of Active (Experimental); Split-Face Application of Comparator

Facial Cleanser OTHER

Facial cleanser was to be used by subjects twice daily during the 14-day washout period and three times daily during the 14-day post-procedure timeline.

Also known as: Gentle Foaming Cleanser, Revision Skincare

Split-Face Application of Active (Experimental); Split-Face Application of Comparator

Facial Moisturizer OTHER

A bland facial moisturizer was to be used by subjects twice daily during the 14-day washout period and three times daily between day 3 and 14 post-procedure. Two pumps were to be applied to the face (avoiding the upper eyelid) after applying the active and comparator.

Split-Face Application of Active (Experimental); Split-Face Application of Comparator

Sunscreen OTHER

During the 14-day washout period, a bland sunscreen was to be used by subjects in the morning after cleansing and facial moisturizer application with reapplications as needed throughout the day per FDA recommendations. For days 3-14 post-procedure, the bland sunscreen was to be used daily by subjects in the morning and afternoon after cleansing, split-face application of the active post-procedure cream and comparator anhydrous formulation, and facial moisturizer application.

Also known as: Neutrogena Sheer Zinc SPF 50

Split-Face Application of Active (Experimental); Split-Face Application of Comparator

Basic Ointment OTHER

The basic ointment was used only on the comparator side for three days (72 hours) post-procedure. This was a requirement of the comparator anhydrous formulation.

Also known as: Vanicream Moisturizing Ointment

Split-Face Application of Comparator

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects 35-65 years of age
• Fitzpatrick Skin Type I to III
• Any race or ethnicity
• Moderate to Severe Overall Photodamage (global face) (score of 4 to 9 out of the 10-point Modified Griffiths' scale, where 0 = none and 9 = severe)
• No known medical conditions that, in the Investigator's opinion, may interfere with study participation.
• Willing to discontinue all active topical facial products and only use the assigned test products for the duration of the study.
• Female subjects of childbearing potential must be willing to use a form of birth control during the study.

You may not qualify if:

• Nursing, pregnant, or planning a pregnancy during this study.
• Having undergone a chemical peel, microdermabrasion, hydro dermabrasion or anti-aging facial within 1 month; non-ablative laser (including IPL) or non-ablative fractional laser resurfacing of the face within 6 months; ablative laser resurfacing of the face within 12 months.
• Not willing to discontinue active topical facial products for 14 days prior to the Baseline Visit

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

The Dermatology Group

Blue Ash, Ohio, 45242, United States

Location

Related Publications (1)

• Weir NM, Burns AJ, Kononov T, Zahr AS. A Novel Neurocosmetic Postprocedure Cream for Optimal Recovery and Tolerability From Energy-Based Devices. Lasers Surg Med. 2025 Dec;57(10):788-798. doi: 10.1002/lsm.70078. Epub 2025 Nov 24.

  PMID: 41286587 DERIVED

MeSH Terms

Conditions

Cutis Laxa

Interventions

Sunscreening Agents

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Nathan Weir, MD, PhD

  The Dermatology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator anhydrous formulation on the opposite side of the face. The products were packaged in the same container and labelled post-procedure cream. This was a double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety were blinded to group during the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Single-Center, Double-Blinded, Split-Face, Controlled

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: October 3, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: August 3, 2025

Record last verified: 2024-04

Locations

US (1)