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

NCT06633731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-10-09

No results posted yet for this study

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

Interventions

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

Gentle Cleanser

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

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.

Sponsors & Collaborators

  • Tone Dermatology

    collaborator UNKNOWN

  • Revision Skincare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2024-03-19
Completion
2024-03-19

Countries

  • United States

Study Locations

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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 NCT06633731 on ClinicalTrials.gov