PhotoagingNCT06157853
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
A study testing Radiofrequency Microneedling, 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, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects… 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
- What is being tested?
- Radiofrequency Microneedling, 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 23 Aug 2022
- 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
- Female subjects must be between 35-65 years of age.
- Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- Subjects with Fitzpatrick I-VI photo skin type.
- Subjects must have moderate photodamage (Grade II or III) using the Glogau Scale of Photoaging.
- 6. Subjects interested in Radiofrequency Microneedling treatments. 7. Subjects must have no skin disease in the facial area being evaluated. 8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects must be wiling to discontinue all active topical facial products and must only use the assigned study products to the face and neck for the duration of the study.
Who cannot join
- Subjects being or planning to become pregnant or breastfeeding during the study
- Having received a chemical peel, dermabrasion or microneedling treatment in the previous six months; laser resurfacing (ablative, non-ablative) in the previous twelve months
- Unwilling to refrain from pain medications post-procedure
- Unwilling to discontinue topical anti-aging facial products for one week prior to study commencement or on prescription strength retinoids or skin lightening produces within two months of the study.
- Subjects who have a Glogau Score of I or IV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: A Randomized, Single-Center, Double-Blinded, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging. Furthermore, this clinical trial will compare the active post-procedure cream to a comparator anhydrous cream product often paired with skin rejuvenation procedures.
A total of 11 healthy female subjects completed the study. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
Read the detailed description
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging in improving patient downtime specifically in minimizing tolerability parameters (erythema, edema, dryness, burning, stinging, and itch) to assist in soothing skin after radiofrequency microneedling procedure.
A 7-day washout period is required for all subjects prior to radiofrequency microneedling procedure. Tolerability (investigator and subject) and safety will be assessed through grading at baseline, post-procedure, post-procedure/post-product application, twenty-four (24) hours post-procedure, three days post-procedure, and seven days post-procedure.
Tolerability parameters included erythema, edema, dryness, burning, stinging, and itch. Efficacy evaluation using the Glogau photoaging scale was performed at screening, baseline, and day 7 post-procedure. The Global Aesthetic Improvement Scale (GAIS) was performed at day 7-post procedure. Self-assessment questionnaire and clinical photography will be completed at all timepoints.
A total of 11 subjects completed study participation. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
- Conditions
- Photoaging, Wrinkle
- Being tested
- Radiofrequency Microneedling, Facial Cleanser, Facial Moisturizer, Sunscreen
- Keywords
- post-procedure, radiofrequency microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency MicroneedlingProcedure or surgery
Also called Fractional biopolar radiofrequency microneedling, InMode
A fractional bipolar radiofrequency microneedling device will be performed at Visit 2, after the 7-day washout period. Subjects were numbed 45 minutes prior to RF microneedling with topical numbing Benzocaine 20%/Lidocaine 6%/tetracaine 4%. Bony areas, periorbital, forehead, and chin were treated with 15 watts at a 2 mm needle depth on cycle mode. All subjects received 20 watts at 3 mm depth on cycle mode on soft tissue, neck, and cheeks.
Facial CleanserOther
Facial cleanser to be used by subjects twice-daily. This product was used during the entire 14-day study (7-day washout period and 7-day post-procedure timeline).
Facial MoisturizerOther
Bland moisturizer to be used by subjects twice daily during the 7-day washout period. Use 1 to 2 pumps and place all over face and avoid the eye area.
SunscreenOther
Also called Neutrogena Sheer Zinc SPF 50
Bland sunscreen to be used by subjects after cleansing and the facial moisturizer during the 7-day washout period. Bland sunscreen to be used by subjects after cleansing and after the active post-procedure cream and comparator anhydrous cream. Use the provided sunscreen and reapply as needed throughout the day and per recommendation of the FDA, every 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Active Post-Procedure Cream | Active comparator | Dosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants.
Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck.
Study duration: 14 days. Active Post-Procedure Cream duration 7-days. Receives: Procedure: Radiofrequency Microneedling; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen |
| Comparator Anhydrous Cream | Other | Dosage Form: anhydrous cream containing peptides, and antioxidants.
Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck.
Study duration: 14 days. Comparator Anhydrous Cream duration 7-days. Receives: Procedure: Radiofrequency Microneedling; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Tolerability Scores
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale 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 immediate post-procedure and through-out the length of the study.
Measured: 14-days
Subject Tolerability Scores
Subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome.
0 = None
- = Mild
- = Moderate
- = Severe
Measured: 14 days
Secondary outcomes (2)
Clinical Efficacy Grading
To evaluate the efficacy of the neurocosmetic on self-perceived improvement and objective grading. Investigator clinical grading, using the Glogau photoaging scale performed at Visit 1 (screening), Visit 2 (baseline, 7-days post-washout), and Visit 5 (14 days).
The Global Aesthetic Improvement Scale (GAIS) to be completed at Visit 5 (14 days).
GAIS Scoring:
Very much improved- Optimal cosmetic result for the treatment in this patient. Much improved- Marked improvement in appearance but not completely optimal for this patient. A touch-up would slightly improve the result.
Improved - Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.
No change- The appearance is the same as than the original condition. Worse- The appearance is worse than the original condition.
Measured: 14 days
Self-Assessment Questionnaire
The secondary efficacy endpoint will be the Self-Assessment Questionnaire. A change in response values at post-procedure/post-product application (Visit 2), Day 1 (Visit 3), Day 3 (Visit 4), and Day 7 (Visit 5) indicates, and improvement compared to baseline response values. 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 posted6 Dec 2023
- Study start11 Jul 2022
- Primary completion22 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, controlled.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Micahel Gold, MD, Principal investigator, Tennesse Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157853
- Sponsor's protocol ID
- RVSN-05-222
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Double-Blinded, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT06157853
- Acronym / sponsor ID
- RVSN-05-222
- Conditions
- Photoaging, Wrinkle
- Keywords
- post-procedure, radiofrequency microneedling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 6 Dec 2023 (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, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging. Furthermore, this clinical trial will compare the active post-procedure cream to a comparator anhydrous cream product often paired with skin rejuvenation procedures.
A total of 11 healthy female subjects completed the study. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
Detailed description
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging in improving patient downtime specifically in minimizing tolerability parameters (erythema, edema, dryness, burning, stinging, and itch) to assist in soothing skin after radiofrequency microneedling procedure.
A 7-day washout period is required for all subjects prior to radiofrequency microneedling procedure. Tolerability (investigator and subject) and safety will be assessed through grading at baseline, post-procedure, post-procedure/post-product application, twenty-four (24) hours post-procedure, three days post-procedure, and seven days post-procedure.
Tolerability parameters included erythema, edema, dryness, burning, stinging, and itch. Efficacy evaluation using the Glogau photoaging scale was performed at screening, baseline, and day 7 post-procedure. The Global Aesthetic Improvement Scale (GAIS) was performed at day 7-post procedure. Self-assessment questionnaire and clinical photography will be completed at all timepoints.
A total of 11 subjects completed study participation. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
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, controlled.
| Arm | Type | Receives |
|---|---|---|
| Active Post-Procedure Cream | Active comparator | Procedure: Radiofrequency Microneedling, Other: Facial Cleanser, Other: Facial Moisturizer, Other: SunscreenDosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants. Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck. Study duration: 14 days. Active Post-Procedure Cream duration 7-days. |
| Comparator Anhydrous Cream | Other | Procedure: Radiofrequency Microneedling, Other: Facial Cleanser, Other: Facial Moisturizer, Other: SunscreenDosage Form: anhydrous cream containing peptides, and antioxidants. Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck. Study duration: 14 days. Comparator Anhydrous Cream duration 7-days. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects must be between 35-65 years of age.
- Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- Subjects with Fitzpatrick I-VI photo skin type.
- Subjects must have moderate photodamage (Grade II or III) using the Glogau Scale of Photoaging.
- 6. Subjects interested in Radiofrequency Microneedling treatments. 7. Subjects must have no skin disease in the facial area being evaluated. 8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects must be wiling to discontinue all active topical facial products and must only use the assigned study products to the face and neck for the duration of the study.
Key exclusion criteria (5 listed)
- Subjects being or planning to become pregnant or breastfeeding during the study
- Having received a chemical peel, dermabrasion or microneedling treatment in the previous six months; laser resurfacing (ablative, non-ablative) in the previous twelve months
- Unwilling to refrain from pain medications post-procedure
- Unwilling to discontinue topical anti-aging facial products for one week prior to study commencement or on prescription strength retinoids or skin lightening produces within two months of the study.
- Subjects who have a Glogau Score of I or IV.
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 |
|---|---|---|
| Radiofrequency MicroneedlingAlso: Fractional biopolar radiofrequency microneedling, InModeA fractional bipolar radiofrequency microneedling device will be performed at Visit 2, after the 7-day washout period. Subjects were numbed 45 minutes prior to RF microneedling with topical numbing Benzocaine 20%/Lidocaine 6%/tetracaine 4%. Bony areas, periorbital, forehead, and chin were treated with 15 watts at a 2 mm needle depth on cycle mode. All subjects received 20 watts at 3 mm depth on cycle mode on soft tissue, neck, and cheeks. | Procedure or surgery | Active Post-Procedure Cream, Comparator Anhydrous Cream |
| Facial CleanserFacial cleanser to be used by subjects twice-daily. This product was used during the entire 14-day study (7-day washout period and 7-day post-procedure timeline). | Other | Active Post-Procedure Cream, Comparator Anhydrous Cream |
| Facial MoisturizerBland moisturizer to be used by subjects twice daily during the 7-day washout period. Use 1 to 2 pumps and place all over face and avoid the eye area. | Other | Active Post-Procedure Cream, Comparator Anhydrous Cream |
| SunscreenAlso: Neutrogena Sheer Zinc SPF 50Bland sunscreen to be used by subjects after cleansing and the facial moisturizer during the 7-day washout period. Bland sunscreen to be used by subjects after cleansing and after the active post-procedure cream and comparator anhydrous cream. Use the provided sunscreen and reapply as needed throughout the day and per recommendation of the FDA, every 2 hours. | Other | Active Post-Procedure Cream, Comparator Anhydrous Cream |
Primary outcome
Investigator Tolerability Scores
Time frame: 14 days
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale 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 immediate post-procedure and through-out the length of the study.
Subject Tolerability Scores
Time frame: 14 days
Subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe
2 secondary outcomes
Clinical Efficacy Grading
Time frame: 14 days
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 10 Apr 2024.
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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.
Micahel Gold, MD principal investigator
Tennesse Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Microneedling, 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 5 inclusion and 5 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 10 Apr 2024. 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 Scores (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?
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 Apr 2024.