A Clinical Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment For Facial Rejuvenation

A Clinical Study To Evaluate the Efficacy and Tolerance of a Topical Facial Treatment on Women With Mild to Moderate Fine Lines, Wrinkles, and Laxity on the Global Face

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.

Study Overview

• Status: Completed
• Conditions: Laxity; Skin; Wrinkles; Fine Lines
• Intervention / Treatment: Other: Gentle Cleanser; Other: Facial Moisturizer; Other: sunscreen SPF 30

Detailed Description

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity.

The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • SGS Stephens, inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Having Fitzpatrick Skin Type I - VI
• Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).

Exclusion Criteria:

• Breastfeeding, pregnant, or planning to become pregnant during the study.
• Currently having or having a history of cold sores (Herpes simplex) on the face.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Topical Treatment; Subjects received a topical facial treatment applied by a license esthetician in a series of 3 sessions at 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks.

Other: Gentle Cleanser; The cleanser was instructed to be used twice daily over the course of 12 weeks; Other Names: Gentle Foaming Cleanser, Revision Skincare; Other: Facial Moisturizer; The Moisturizer was instructed to be applied to the global face twice daily over the course of 12 weeks.; Other: sunscreen SPF 30; The Sunscreen was instructed to be applied once daily in the morning, with re-application with extended sun exposure per FDA guidelines over the course of 12 weeks.; Other Names: Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Investigator Clinical Efficacy Grading versus Baseline	The primary efficacy endpoint will be Investigator Clinical Efficacy grading of parameters at baseline, post-application, and weeks 4, 8, and 12. the efficacy parameters will be assessed by the expert grader on each subjects global face using a modified Griffiths 10-point scale. A decrease in score indicates an improvement.	12 weeks
Lack of significant change in Investigator Tolerability Parameters versus Baseline	The primary tolerability endpoint will be Investigator Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by the expert grader by assessing the signs of erythema and dryness using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.	12 weeks
Lack of significant change in Subjective Tolerability versus Baseline	The primary tolerability endpoint will be Subjective Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by subject reporting of the degree of burning, stinging, and itching globally on each subject's global face using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement	The secondary endpoint will be subject self-assessment questionnaire completed at baseline, post-application, and weeks 4, 8, and 12. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). A change in response values at post-application, and weeks 4, 8, and 12 compared to baseline response values indicates an improvement. The best outcome is to Completely Agree with the statement / question being asked.	12 weeks
Clinical Photography: VISIA-CR and Antera 3D	The secondary endpoint will be image analysis of VISIA-CR and Antera 3D clinical photography. VISIA-CR imaging analysis for nasolabial folds, and Antera imaging analysis of roughness and volume on images taken at all timepoints. a reduction in visual fine lines, wrinkles, radiance, and laxity on post-baseline timepoints compared to baseline is indicated an improvement	12 weeks

Collaborators and Investigators

• Sponsor: Revision Skincare
• Collaborators: SGS Stephens, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: topical treatment; anti-aging; skin rejuvenation
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: C22-D008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No