Fine Lines, Wrinkles, Laxity; Skin
Conditions
Keywords
topical treatment, skin rejuvenation, anti-aging
Brief summary
This single-center clinical 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, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.
Detailed description
This single-center clinical 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, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.
Interventions
OTHERGentle Cleanser
The cleanser was instructed to be used twice daily over the course of 12 weeks
OTHERFacial Moisturizer
The Moisturizer was instructed to be applied to the global face twice daily over the course of 12 weeks.
OTHERsunscreen SPF 30
The Sunscreen was instructed to be applied once daily in the morning, with re-application with extended sun exposure per FDA guidelines over the course of 12 weeks.
Sponsors
SGS Stephens, Inc
Revision Skincare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Having Fitzpatrick Skin Type I - VI * Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).
Exclusion criteria
* Breastfeeding, pregnant, or planning to become pregnant during the study. * Currently having or having a history of cold sores (Herpes simplex) on the face.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Investigator Clinical Efficacy Grading versus Baseline | 12 weeks | The primary efficacy endpoint will be Investigator Clinical Efficacy grading of parameters at baseline, post-application, and weeks 4, 8, and 12. the efficacy parameters will be assessed by the expert grader on each subjects global face using a modified Griffiths 10-point scale. A decrease in score indicates an improvement. |
| Lack of significant change in Investigator Tolerability Parameters versus Baseline | 12 weeks | The primary tolerability endpoint will be Investigator Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by the expert grader by assessing the signs of erythema and dryness 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 primary tolerability endpoint will be Subjective Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by subject reporting of the degree of burning, stinging, and itching globally on each subject's global face 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 |
|---|---|---|
| Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement | 12 weeks | The secondary endpoint will be subject self-assessment questionnaire completed at baseline, post-application, and weeks 4, 8, and 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 post-application, and 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. |
| Clinical Photography: VISIA-CR and Antera 3D | 12 weeks | The secondary endpoint will be image analysis of VISIA-CR and Antera 3D clinical photography. VISIA-CR imaging analysis for nasolabial folds, and Antera imaging analysis of roughness and volume on images taken at all timepoints. a reduction in visual fine lines, wrinkles, radiance, and laxity on post-baseline timepoints compared to baseline is indicated an improvement |
Countries
United States
Outcome results
None listed