PhotoagingNCT06366503
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
A study testing Fractional Ablative CO2 Laser, Facial Cleanser and Facial Moisturizer in people with Photoaging and Wrinkle, run by Revision Skincare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Wrinkle, Skin Laxity
- What is being tested?
- Fractional Ablative CO2 Laser, Facial Cleanser and Facial Moisturizer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 29 Dec 2023
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Center, Double-Blinded, Split-Face, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
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.
Read the detailed description
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). The ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters (erythema, edema, dryness, burning, itching, stinging) and pain over the course of the study. Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures.
A 14-day washout period was required of all subjects prior to CO2 laser treatment. Tolerability (investigator: erythema, edema, dryness; subject: burning, itching, stinging) and safety were assessed through grading at screening, pre-procedure, post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure. Pain evaluations were completed by subjects using the 11-point Wong Baker Faces® Pain Rating scale post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure.
In addition, efficacy evaluation using the Modified Griffiths' scale was performed at screening, pre-procedure, and days 1, 3, 5, 7, and 14 post-procedure. Self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 3, and 14 post-procedure. Clinical photography was completed at all timepoints (screening to day 14 post-procedure).
A total of 22 subjects completed study participation.
- Conditions
- Photoaging, Wrinkle, Skin Laxity
- Being tested
- Fractional Ablative CO2 Laser, Facial Cleanser, Facial Moisturizer, Sunscreen, Basic Ointment
- Keywords
- post-procedure, Fractional Ablative CO2 Laser
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Ablative CO2 LaserProcedure or surgery
Also called DEKA SmartXide Tetra CO2 laser treatment
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.
Facial CleanserOther
Also called Gentle Foaming Cleanser, Revision Skincare
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.
Facial MoisturizerOther
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.
SunscreenOther
Also called Neutrogena Sheer Zinc SPF 50
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.
Basic OintmentOther
Also called Vanicream Moisturizing Ointment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Fractional Ablative CO2 Laser; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen; Other: Basic Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = Mild
- = Moderate
- = Severe
Measured: 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.
Measured: 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
- = Mild
- = Moderate
- = Severe
Measured: 14 days
Secondary outcomes (1)
Self-Assessment Questionnaire
A change in response values at Day 1 (24 hours), Day 3, and Day 14 compared to post-procedure/post-product application response values indicates an improvement. Baseline responses will be set to post-procedure/post-product application. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 Oct 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Single-Center, Double-Blinded, Split-Face, Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Weir, MD, PhD, Principal investigator, The Dermatology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366503
- Sponsor's protocol ID
- RS-2023-05
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 41286587
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Double-Blinded, Split-Face, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT06366503
- Acronym / sponsor ID
- RS-2023-05
- Conditions
- Photoaging, Wrinkle, Skin Laxity
- Keywords
- post-procedure, Fractional Ablative CO2 Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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). The ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters (erythema, edema, dryness, burning, itching, stinging) and pain over the course of the study. Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures.
A 14-day washout period was required of all subjects prior to CO2 laser treatment. Tolerability (investigator: erythema, edema, dryness; subject: burning, itching, stinging) and safety were assessed through grading at screening, pre-procedure, post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure. Pain evaluations were completed by subjects using the 11-point Wong Baker Faces® Pain Rating scale post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure.
In addition, efficacy evaluation using the Modified Griffiths' scale was performed at screening, pre-procedure, and days 1, 3, 5, 7, and 14 post-procedure. Self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 3, and 14 post-procedure. Clinical photography was completed at all timepoints (screening to day 14 post-procedure).
A total of 22 subjects completed study participation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Single-Center, Double-Blinded, Split-Face, Controlled
| Arm | Type | Receives |
|---|---|---|
| Split-Face Application of Active (Experimental) | Experimental | Procedure: Fractional Ablative CO2 Laser, Other: Facial Cleanser, Other: Facial Moisturizer, Other: SunscreenActive (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. |
| Split-Face Application of Comparator | Active comparator | Procedure: Fractional Ablative CO2 Laser, Other: Facial Cleanser, Other: Facial Moisturizer, Other: Sunscreen, Other: Basic OintmentCOMPARATOR: 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Ablative CO2 LaserAlso: DEKA SmartXide Tetra CO2 laser treatmentA 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. | Procedure or surgery | Split-Face Application of Active (Experimental), Split-Face Application of Comparator |
| Facial CleanserAlso: Gentle Foaming Cleanser, Revision SkincareFacial 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. | Other | Split-Face Application of Active (Experimental), Split-Face Application of Comparator |
| Facial MoisturizerA 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. | Other | Split-Face Application of Active (Experimental), Split-Face Application of Comparator |
| SunscreenAlso: Neutrogena Sheer Zinc SPF 50During 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. | Other | Split-Face Application of Active (Experimental), Split-Face Application of Comparator |
| Basic OintmentAlso: Vanicream Moisturizing OintmentThe 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. | Other | Split-Face Application of Comparator |
Primary outcome
Investigator Tolerability
Time frame: 14 days
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
Incidence of Adverse Events
Time frame: 14-days
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.
Subject Tolerability
Time frame: 14 days
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
1 secondary outcome
Self-Assessment Questionnaire
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 41286587Weir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Weir, MD, PhD principal investigator
The Dermatology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Ablative CO2 Laser, Facial Cleanser and Facial Moisturizer in people with Photoaging and Wrinkle, run by Revision Skincare at 1 site in United States.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Tolerability (time frame: 14 days). The study lists 3 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 NCT06366503, which also lists 1 linked publication.
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 3 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.