Fine LinesNCT05271136
A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
A study testing Anti-aging Serum, Facial Moisturizer and Cleansing Lotion in people with Fine Lines and Wrinkle, run by Revision Skincare at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fine Lines, Wrinkle, Photoaging
- What is being tested?
- Anti-aging Serum, Facial Moisturizer and Cleansing Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 13 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Controlled Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
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.
Read the detailed description
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.
- Conditions
- Fine Lines, Wrinkle, Photoaging
- Being tested
- Anti-aging Serum, Facial Moisturizer, Cleansing Lotion, Sunscreen
- Keywords
- anti-aging, serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-aging SerumOther
Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers
Facial MoisturizerOther
Anti-aging facial moisturizer to be used by study participants after serum
Cleansing LotionOther
Also called Revision Skincare® Cleansing Lotion
Facial cleansing lotion to be used by study participants
SunscreenOther
Also called Aveeno Positively Mineral Sensitive Skin SPF 40+
Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours
SunscreenOther
Also called Aveeno Positively Mineral Sensitive Skin SPF 40+
Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Anti-aging Serum; Other: Cleansing Lotion; Other: Sunscreen |
| 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 Receives: Other: Anti-aging Serum; Other: Facial Moisturizer; Other: Cleansing Lotion; Other: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- = Mild Slight, but definite redness of the treatment area
- = Moderate Definite redness of the treatment area
- = Severe Marked redness of the treatment area
Measured: 7 days
Secondary outcomes (4)
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
- = Mild Slight burning sensation of the treatment area; not really bothersome
- = Moderate Definite warm, burning of the treatment area that is somewhat bothersome.
- = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start30 Sep 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, controlled, single-center
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Tanja Emmerich, PhD, Principal investigator, SGS Stephens, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271136
- Sponsor's protocol ID
- C20-D146
- Status last verified
- Feb 2022
- First submitted
- 29 Sep 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
- ClinicalTrials.gov ID
- NCT05271136
- Acronym / sponsor ID
- C20-D146
- Conditions
- Fine Lines, Wrinkle, Photoaging
- Keywords
- anti-aging, serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, controlled, single-center
| Arm | Type | Receives |
|---|---|---|
| Cell 1: Anti-aging Serum | Active comparator | Other: Anti-aging Serum, Other: Cleansing Lotion, Other: SunscreenDosage 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 |
| Cell 2: Anti-aging Serum and Facial Moisturizer | Active comparator | Other: Anti-aging Serum, Other: Facial Moisturizer, Other: Cleansing Lotion, Other: SunscreenDosage 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-aging SerumSerum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers | Other | Cell 1: Anti-aging Serum, Cell 2: Anti-aging Serum and Facial Moisturizer |
| Facial MoisturizerAnti-aging facial moisturizer to be used by study participants after serum | Other | Cell 2: Anti-aging Serum and Facial Moisturizer |
| Cleansing LotionAlso: Revision Skincare® Cleansing LotionFacial cleansing lotion to be used by study participants | Other | Cell 1: Anti-aging Serum, Cell 2: Anti-aging Serum and Facial Moisturizer |
| SunscreenAlso: Aveeno Positively Mineral Sensitive Skin SPF 40+Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours | Other | Cell 1: Anti-aging Serum |
| SunscreenAlso: Aveeno Positively Mineral Sensitive Skin SPF 40+Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours | Other | Cell 2: Anti-aging Serum and Facial Moisturizer |
Primary outcome
Clinical Grading of Efficacy Parameters
Time frame: 7 days
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.
Tolerability Evaluations
Time frame: 7 days
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 1. = Mild Slight, but definite redness of the treatment area 2. = Moderate Definite redness of the treatment area 3. = Severe Marked redness of the treatment area
4 secondary outcomes
Irritation Evaluation
Time frame: 7 days
Self-assessment Questionnaire
Time frame: 7 days
Bioinstrumentation Measurements
Time frame: 7 days
VISIA-CR Photography
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Emmerich, PhD principal investigator
SGS Stephens, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-aging Serum, Facial Moisturizer and Cleansing Lotion in people with Fine Lines and Wrinkle, run by Revision Skincare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Grading of Efficacy Parameters (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.