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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.
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.
Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.
Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.
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.
Tone Dermatology
Chicago, Illinois, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Clinical Photography: VISIA-CR and Antera 3D
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
Time frame: 12 weeks
Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement
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.
Time frame: 12 weeks
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