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| Name | Class |
|---|---|
| Stephens & Associates, Inc. | INDUSTRY |
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This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer. A total of 26 female subjects, aged 34-60, completed study participation.
This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer (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, day 3, and day 7. 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 15 minutes post product application. Self-assessment questionnaires, Glossymeter measurements, and VISIA photography were completed at baseline, day 3, and day 7.
A total of 26 subjects completed study participation, which included 12 subjects in Cell 1, and 14 subjects in Cell 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell 1: Anti-aging Serum | Active Comparator | Dosage form: Anti-aging Serum Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum. Study Duration: 7 days |
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| Cell 2: Anti-aging Serum and Facial Moisturizer | Active Comparator | Dosage form: Anti-aging Serum and Facial Moisturizer Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum, and then 2 pumps of the Facial Moisturizer to the global face. Study Duration: 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-aging Serum | Other | Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Grading of Efficacy Parameters | The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 3, and Day 7 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. | 7 days |
| Tolerability Evaluations | The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at Day 3, and Day 7 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
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Evaluation | The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at Day 3, and Day 7 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
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Emmerich, PhD | SGS Stephens, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stephens, Inc. | Richardson | Texas | 75081 | United States |
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| ID | Term |
|---|---|
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
| D013473 | Sunscreening Agents |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Randomized, double-blind, controlled, single-center
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Randomization occurred by assignment to either Cell 1 or Cell 2 using a randomization list, prepared by Stephens prior to the start of the study. The list was first created by concatenating blocks of size of 4 subjects, 2 for Cell 1 and 2 for Cell 2. The list was then randomized by variables from 2 independent uniform distributions: one to randomize subjects within a block and one to randomized blocks. After the randomized list was created, treatment was assigned to each subject number accordingly.
| Facial Moisturizer | Other | Anti-aging facial moisturizer to be used by study participants after serum |
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| Cleansing Lotion | Other | Facial cleansing lotion to be used by study participants |
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| Sunscreen | Other | Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours |
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| Sunscreen | Other | Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours |
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| 7 days |
| Self-assessment Questionnaire | The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A decrease or increase in response values at Day 3, and Day 7 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. | 7 days |
| Bioinstrumentation Measurements | The secondary efficacy endpoints will be the Glossymeter measurements. Measurements of the gloss of the skin, taken at Day 3 and Day 7 in comparison to baseline, will measure the white light, created by LEDs, directly reflected from the skin. | 7 days |
| VISIA-CR Photography | VISIA-CR photography taken at Baseline, Day 3 and Day 7 with image analysis at the end of the study. | 7 days |
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |