- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514782
A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
West Chester, Pennsylvania, United States, 19073
- Kgl Skin Study Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female 30 to 60 years of age
- Fitzpatrick skin type I -IV
- Moderate overall photodamage of the skin
- Moderate lack of firmness (visual) of the skin
- Moderate dull appearance of the skin
- Subjects must be willing to withhold all facial treatments during the course of the study and have not undergone a treatment within the last 6 months
- Subject must be willing to provide verbal understanding and written informed consent
Exclusion Criteria:
- Diagnosed with known allergies to facial skincare products
- Nursing, pregnant, or planning to become during the duration of the study
- History of skin cancer within the past 5 years
- Having used oral isotretinoin within the last 12 months
- Having used prescription-strength skin-lightening products within the last 3 months
- Having used any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within the last 4 weeks
- Having a health condition and/or pre-existing or dermatologic disorder that, in the Investigator's opinion, may interfere with the outcome of the study
- Having observable sunburn, suntan, scars, excessive facial hair, or other dermal conditions on the face that, in the Investigator's opinion, may influence test results
- Having a history of immunosuppression/immune deficiency disorders, or currently using oral or systemic immunosuppressive medications and biologics, and/or undergoing radiation or chemotherapy
- Using or having regularly used systemic or topical corticosteroids within the past 4 weeks
- Having started a long-term medication within the last 2 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Anti-Aging Daily Serum
Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers.
New product in development.
|
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Other Names:
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Other Names:
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
Other Names:
|
Placebo Comparator: Placebo-Control
Vehicle control of the anti-aging daily serum.
|
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Other Names:
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change In Clinical Efficacy Parameter Radiance Versus Baseline
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time Frame: 12 weeks
|
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
|
12 weeks
|
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time Frame: 12 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement
Time Frame: 12 weeks
|
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. |
12 weeks
|
Bioinstrumentation -Quantitative and Qualitative Data
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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