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

NCT06633731 | Completed

• 1 other identifier: RS-2023-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Smoothness; Radiance; Overall Appearance

Keywords

anti-aging; Fitzpatrick Skin Types V and VI; Skin Rejuvenation

Outcome Measures

Primary Outcomes (3)

• Change in Investigator Clinical Efficacy Grading versus Baseline

  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

  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

  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 Outcomes (2)

• Clinical Photography: VISIA-CR and Antera 3D

  12 weeks

• Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement

  12 weeks

Study Arms (1)

Topical Treatment

EXPERIMENTAL

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; Other: Post Procedure Cream; Other: Gentle Cleanser; Other: Facial Moisturizer; Other: sunscreen

Interventions

Biocellulose Mask OTHER

Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.

Topical Treatment

Post Procedure Cream OTHER

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.

Also known as: CMT Post Procedure Cream, Revision Skincare

Topical Treatment

Gentle Cleanser OTHER

Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.

Also known as: Gentle Foaming Cleanser, Revision Skincare

Topical Treatment

Facial Moisturizer OTHER

Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.

Topical Treatment

sunscreen OTHER

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.

Also known as: Cetaphil® Sheer Mineral Sunscreen SPF 30

Topical Treatment

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead
• Tone Dermatology: collaborator

Study Sites (1)

Tone Dermatology

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 9, 2024
• Study Start: April 24, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)