Status:

COMPLETED

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

Lead Sponsor:

Revision Skincare

Conditions:

Photoaging

Wrinkle

Eligibility:

FEMALE

35-65 years

Phase:

NA

Brief 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 rad...

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 rad...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 11 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 23 2022

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT06157853

Start Date

July 11 2022

End Date

August 23 2022

Last Update

April 10 2024

Active Locations (1)

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1

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215