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| Name | Class |
|---|---|
| KGL, Inc. | OTHER |
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This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.
This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 12-weeks days of twice-daily use when compared to the efficacy of a combination of a placebo-control (Cell 2). Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a dull appearance on the global face.
Efficacy and tolerability were assessed through clinical grading at baseline, week 4, week 8, and week 12. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and overall photodamage on the global face were performed at baseline and post-baseline by a clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at baseline and week 12 were performed by two board certified dermatologists.
Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects, a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies collected from the lateral, pre-auricular at baseline and week 12.
A total of 62 subjects completed study participation (31 in Cell 1 and 31 in Cell 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-Aging Daily Serum | Active Comparator | Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers. New product in development. |
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| Placebo-Control | Placebo Comparator | Vehicle control of the anti-aging daily serum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleansing Lotion | Other | Facial cleansing lotion to be used by study participants (morning and evening, 2x daily). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change In Clinical Efficacy Parameter Radiance Versus Baseline | The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints. A decrease in scores at post-baseline timepoints (week 4,8, and12) in comparison to baseline indicates an improvement for the indicated parameter. The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome. | 12 weeks |
| Change in Active Cell versus Placebo Control in Clinical Efficacy at week 12 | The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints versus the placebo control. A confidence interval of 90% (p <0.10) for both live clinical grading and photo-grading will be performed between the Cell 1 (active comparator) versus Cell 2 (placebo control comparator). The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline | The second outcome measure is objective tolerability endpoint. Investigator Tolerability Assessment includes Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at week 4, 8, and 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema: Erythema 0 = None No erythema of the treatment area
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| Measure | Description | Time Frame |
|---|---|---|
| Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement | Self-Assessment Questionnaire and the Subject Treatment Satisfaction. A decrease or increase in response values at week 4, 8, and 12, and indicates an improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement/ question being asked. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL Skin Study Center | West Chester | Pennsylvania | 19073 | United States |
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| ID | Term |
|---|---|
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
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Randomized, double-blinded, placebo-controlled, single-center
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Randomization occurred by assignment to either Cell 1 or Cell 2 using a randomization list, prepared by KGL Skin prior to the start of the study.
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| Facial Moisturizer | Other | Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen. |
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| Sunscreen SPF 40+ | Other | Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours. Per FDA this intervention is an Over the counter |
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| 12 weeks |
| Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline | The secondary tolerability endpoint will be the Subjective Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at week 4, 8, and 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example Burning. 0 = None No burning of the treatment area
| 12 weeks |
| 12 weeks |
| Bioinstrumentation -Quantitative and Qualitative Data | Bioinstrumentation measurements includes Antera 3D imaging (Miravex Limited, Dublin, Ireland). Measurements are taken of either the right or left cheek area at baseline, week 8 and week 12. Comparisons are made to baseline. A decrease in skin redness and skin melanin pigmentation indicates an improvement. | 12 weeks |
| Bioinstrumentation - Quantitative and Qualitative Data | Bioinstrumentation measurements includes Ultrasound Imaging (DermaScan C; Cortex Technology, Hadsund, Denmark). Measurements are taken of either the right or left cheek area at baseline, week 8 and week 12. Comparisons are made to baseline. An increase in skin density over time indicates improvement. | 12 weeks |