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A clinical study with approximately 40 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ~25 subjects, aged 35-65, will receive Investigational Facial Serum #1 | Experimental |
| |
| ~15 subjects, aged 35-65, will receive Investigational Facial Serum #2 | Active Comparator |
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| 0 subjects, aged 35-65, will receive Investigational Facial Serum #3 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Facial Serum #1 | Other | Investigational Facial Serum #1 is made with Activated Silk™ 27P-α. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9 | Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 28 vs. Day 0. | Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in appearance of skin characteristics | Change in appearance of skin firmness through expert grading for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0. | From Day 0 to Day 28 |
| Change in appearance of skin characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evolved By Nature | Needham | Massachusetts | 02494 | United States |
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| Investigational Facial Serum #2 | Other | Investigational Facial Serum #2 is made with an active comparator. |
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| Investigational Facial Serum #3 | Other | Investigational Facial Serum #3 is a placebo comparator |
|
Change in surface hydration as measured by the Corneometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0. |
| From Day 0 to Day 28 |
| Change in appearance of skin characteristics | Change in transepidermal water loss measured by the Tewometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0. | From Day 0 to Day 28 |
| Change in appearance of skin characteristics | Subject reported improvements from the self-perception questionnaire with subject responses of agree, strongly agree, disagree, strongly disagree for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0. | From Day 0 to Day 28 |