Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

October 7, 2024 updated by: Revision Skincare
This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance 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)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Tone Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals with Fitzpatrick Skin Type V and VI
  • Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
  • Individuals willing to undergo a washout period of 3 days.

Exclusion Criteria:

  • Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
  • Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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. The treatment included a topical treatment, biocellulose mask, and serum. Additionally, subjects followed a 12 weeks skincare regimen including a gentle cleanser, bland moisturizer, and bland sunscreen.
Other: Biocellulose Mask
Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.
Other: Post Procedure Cream
Immediately after treatment and after Biocellulose Mask removal, the Post-Procedure Cream was applied to the subjects global face. Subjects were instructed to apply to the global face from days 1 - 3 post treatment.
Other Names:
  • CMT Post Procedure Cream, Revision Skincare
Other: Gentle Cleanser
Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.
Other Names:
  • Gentle Foaming Cleanser, Revision Skincare
Other: Facial Moisturizer
Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.
Other: sunscreen
Subjects were instructed to apply the bland sunscreen to the global face once daily in the morning, with re-application with extended sun exposure per FDA guidelines.
Other Names:
  • Cetaphil® Sheer Mineral Sunscreen SPF 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Investigator Clinical Efficacy Grading versus Baseline
Time Frame: 12 weeks
The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Efficacy Grading of radiance, skin smoothness, and overall appearance using a Modified Griffith's 10-point scale at week 4, week 8, and week 12 versus baseline (0:None, 9=Severe). A reduction in score indicates improvement.
12 weeks
Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
Time Frame: 12 weeks
The primary tolerability endpoint will be favorable analysis of Investigator Tolerability grading of erythema, edema and dryness completed by study investigator at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed 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
Time Frame: 12 weeks
The secondary tolerability endpoint will be favorable analysis of Subject Tolerability grading of burning, itching, and stinging completed by subjects at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed 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
Clinical Photography: VISIA-CR and Antera 3D
Time Frame: 12 weeks
The secondary efficacy endpoint will be favorable analysis of clinical photography including VISIA® and Antera 3D® digital imaging at week 4, 8, and 12 versus baseline. A reduction in visual radiance, skin smoothness, and overall appearance on post-baseline timepoints compared to baseline is indicated an improvement
12 weeks
Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement
Time Frame: 12 weeks
The secondary endpoint will be favorable analysis of Self-Assessment Questionnaires completed by subjects at baseline, week 4, week 8, and week 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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revision Skincare

Collaborators

Tone Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

March 19, 2024

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS-2023-01

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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