MedTrace Logo

Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation

NCT06157853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-04-10

No results posted yet for this study

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 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.

Conditions

  • Photoaging
  • Wrinkle

Interventions

PROCEDURE

Radiofrequency Microneedling

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.

OTHER

Facial Cleanser

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).

OTHER

Facial Moisturizer

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.

OTHER

Sunscreen

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.

Sponsors & Collaborators

  • Revision Skincare

    lead INDUSTRY

Principal Investigators

  • Micahel Gold, MD · Tennesse Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2022-08-22
Completion
2022-08-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157853 on ClinicalTrials.gov