Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy of a retinol alternative-containing facial cream in improving skin texture, radiance/brightness, and the appearance of fine lines, wrinkles, uneven skin tone, and dark spots, with a positive control of a retinol-containing cream.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Facial Cream A (Cell A) | Experimental | Each subject will be provided with the assigned IP (Facial Cream A) and the APs to use for 12 weeks. |
|
| Arm 2: Facial Cream B (Cell B) | Experimental | Each subject will be provided with the assigned IP (Facial Cream B) and the APs to use for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Cream A | Other | The participants will use the Facial Cleanser twice daily (morning and evening). The Facial Cream A will be applied topically evenly over the entire face after cleansing and drying face in the morning and in the evening. The Sunscreen will be applied evenly over the entire face after Facial Cream A in the morning and re-applied after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours during sun exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy Assessment | Change from baseline on global fine lines, under-eye wrinkles, and crow's feet wrinkles by clinical evaluation. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-9, where 0=none, 1-3=mild, 4-6=moderate and 7-9=severe. | Visit 5 (Day 84 ± 3) |
| Cutaneous Tolerance Assessment | Change from baseline on erythema, dryness/scaling, burning/stinging, and feeling of dryness/tightness. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-3, where 0=none, 1=mild, 2=moderate and 3=severe. | Visit 3 (Day 28 ± 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy Assessment | Change from baseline on global fine lines, under-eye wrinkles, and crow's feet wrinkles by clinical evaluation. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-9, where 0=none, 1-3=mild, 4-6=moderate and 7-9=severe. | Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); |
Not provided
Inclusion Criteria:
Fitzpatrick Skin Type I, II, III, or IV
Final review of eligibility (Visit 2): Exhibits moderate to severe (score of 4-7 on a 0-9-point scale) overall photodamage on her face, as evaluated by the PI at Visit 2
Final review of eligibility (Visit 2): Has a score of at least 4-7 (moderate to severe, on a 0-9-point scale) on at least 3 of the 5 following clinical grading parameters on her face, as evaluated by the PI at Visit 2:
i. Global fine lines ii. Wrinkles (under-eye and/or crow's feet) iii. Tactile surface roughness iv. Overall unevenness of skin tone v. Lack of radiance/brightness vi. Lack of skin firmness (look and/or feel)
Generally in good health
Able to read, write, speak, and understand English
Individual has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act disclosure
Intends to complete the study and is willing and able to follow all study instructions
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL Skin Study Center, LLC | West Chester | Pennsylvania | 19073 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Facial Cream B | Other | The participants will use the Facial Cleanser twice daily (morning and evening).The Sunscreen will be applied evenly over the entire face after cleansing in the morning and re-applied after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours during sun exposure. The Facial Cream B will be applied in the evening after washing and drying face. |
|
| Clinical Efficacy Assessment | Change from baseline on Tactile surface roughness; Lack of clarity; Lack of global firmness (look); Lack of global skin firmness (feel); Elasticity (pinch recoil evaluation);Overall unevenness of skin tone (brown tones); Lack of radiance/brightness; Overall photodamage; Mottled hyperpigmentation; Discrete pigmentation; Skin elasticity/resiliency via pinch-recoil measurement. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-9, where 0=none, 1-3= mild, 4-6=moderate and 7-9=severe. For Skin elasticity/resiliency, the Principal Investigator will pinch the skin at the test site between the thumb and middle finger, hold the skin in place for approximately two seconds, and then note the time for the skin to return to its original conformation. A decrease in pinch-recoil times indicates an increase in skin elasticity/resiliency. | Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3) |
| Cutaneous Tolerance Assessment | Change from baseline on edema and itching. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-3, where 0=none, 1=mild, 2=moderate and 3=severe. | Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3) |
| Cutaneous Tolerance Assessment | Change from baseline on erythema, dryness/scaling, burning/stinging, and feeling of dryness/tightness. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-3, where 0=none, 1=mild, 2=moderate and 3=severe. | Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3) |
| Self-Assessment | Participant's self-assessment questionnaire to assess the facial skin condition. Participants will answer six questions and rate their responses on a scale from 1 to 10, where a higher score indicates a more positive response. | Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3) |
| Product Assessment | Product assessment questionnaire to assess the percentage of favorable responses compared to unfavorable responses. Participants will answer 23 questions and rate as: Disagree completely, disagree somewhat, neither agree nor disagree, agree somewhat and agree completely. | Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5(Day 84 ± 3) |