PhotoagingNCT05514782
A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
A study testing Cleansing Lotion, Facial Moisturizer and Sunscreen SPF 40+ in people with Photoaging and Wrinkle, run by Revision Skincare at 1 site in United States.
Trial summary
This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). 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
- Photoaging, Wrinkle
- What is being tested?
- Cleansing Lotion, Facial Moisturizer and Sunscreen SPF 40+
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 10 Dec 2021
- 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.
United States1 site
KGL Skin Study Center
West Chester, Pennsylvania, 19073
About this study
Official title: Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum
This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.
Read the 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).
- Conditions
- Photoaging, Wrinkle
- Being tested
- Cleansing Lotion, Facial Moisturizer, Sunscreen SPF 40+
- Keywords
- anti-aging, daily serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleansing LotionOther
Also called Revision Skincare® Cleansing Lotion
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Facial MoisturizerOther
Also called Goodier Cosmetics Facial Moisturizer
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Sunscreen SPF 40+Other
Also called Aveeno Positively Mineral Sensitive Skin SPF 40+)
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
| Study group | Role | What they receive |
|---|---|---|
| Anti-Aging Daily Serum | Active comparator | Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers. New product in development. Receives: Other: Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 40+ |
| Placebo-Control | Placebo comparator | Vehicle control of the anti-aging daily serum. Receives: Other: Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 40+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Clinical Efficacy Parameter Radiance Versus Baseline
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.
Measured: 12 weeks
Change in Active Cell versus Placebo Control in Clinical Efficacy at week 12
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.
Measured: 12 weeks
Secondary outcomes (2)
Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
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
- = Mild Slight, but definite redness of the treatment area
- = Moderate Definite redness of the treatment area
- = Severe Marked redness of the treatment area
Measured: 12 weeks
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
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
- = 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: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Sep 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, single-center
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGL, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514782
- Sponsor's protocol ID
- 8602
- Status last verified
- Oct 2022
- First submitted
- 17 Aug 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum
- ClinicalTrials.gov ID
- NCT05514782
- Acronym / sponsor ID
- 8602
- Conditions
- Photoaging, Wrinkle
- Keywords
- anti-aging, daily serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- KGL, Inc.
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 24 Aug 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, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, single-center
| Arm | Type | Receives |
|---|---|---|
| Anti-Aging Daily Serum | Active comparator | Other: Cleansing Lotion, Other: Facial Moisturizer, Other: Sunscreen SPF 40+Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers. New product in development. |
| Placebo-Control | Placebo comparator | Other: Cleansing Lotion, Other: Facial Moisturizer, Other: Sunscreen SPF 40+Vehicle control of the anti-aging daily serum. |
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 |
|---|---|---|
| Cleansing LotionAlso: Revision Skincare® Cleansing LotionFacial cleansing lotion to be used by study participants (morning and evening, 2x daily). | Other | Anti-Aging Daily Serum, Placebo-Control |
| Facial MoisturizerAlso: Goodier Cosmetics Facial MoisturizerAnti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen. | Other | Anti-Aging Daily Serum, Placebo-Control |
| Sunscreen SPF 40+Also: Aveeno Positively Mineral Sensitive Skin SPF 40+)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 | Anti-Aging Daily Serum, Placebo-Control |
Primary outcome
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.
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.
2 secondary outcomes
Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time frame: 12 weeks
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time frame: 12 weeks
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 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleansing Lotion, Facial Moisturizer and Sunscreen SPF 40+ in people with Photoaging 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 27 Oct 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. Some participants in this study may receive a placebo. 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?
Change In Clinical Efficacy Parameter Radiance Versus Baseline (time frame: 12 weeks). 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 27 Oct 2022.