Skin Smoothness, Radiance, Overall Appearance
Conditions
Keywords
anti-aging, Fitzpatrick Skin Types V and VI, Skin Rejuvenation
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.
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.
Interventions
OTHERBiocellulose Mask
Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.
OTHERPost 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.
OTHERGentle Cleanser
Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.
OTHERFacial Moisturizer
Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.
OTHERsunscreen
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
Tone Dermatology
Revision Skincare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Clinical Efficacy Grading versus Baseline | 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. |
| Lack of Significant Change in Investigator Tolerability Parameters versus Baseline | 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. |
| Lack of Significant Change in Subjective Tolerability versus Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Photography: VISIA-CR and Antera 3D | 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 |
| Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement | 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. |
Countries
United States
Outcome results
None listed