WrinkleNCT04911374
An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream
A study testing Gentle Cleansing Lotion, Revision Skincare and Aveeno Face Milk SPF 40+ in people with Wrinkle and Photoaging, run by Revision Skincare at 1 site in United States.
Trial summary
This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Photoaging, Fine Lines
- What is being tested?
- Gentle Cleansing Lotion, Revision Skincare and Aveeno Face Milk SPF 40+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2020to 3 Feb 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between the ages of 35 and 65 years
- Women with Fitzpatrick skin type I-VI
- Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent.
Who cannot join
- Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
- Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
- Subjects that are unwilling to comply with the protocol
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
- Subjects who spend excessive time out in the sun.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging
This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.
Read the detailed description
This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.
Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.
A total of 42 subjects completed the study.
- Conditions
- Wrinkle, Photoaging, Fine Lines
- Being tested
- Gentle Cleansing Lotion, Revision Skincare, Aveeno Face Milk SPF 40+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Cleansing Lotion, Revision SkincareOther
Gentle cleansing lotion to be used by study participants
Aveeno Face Milk SPF 40+Other
Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Aging Face Moisturizer and Eye Cream | Other | Dual Regimen:
1. Multi-ingredient anti-aging face moisturizer
2. Multi-ingredient anti-aging eye cream Receives: Other: Gentle Cleansing Lotion, Revision Skincare; Other: Aveeno Face Milk SPF 40+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 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
Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline
The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 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
Secondary outcomes (4)
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A change in scores or lack of significant change at week 4, week 8 and week 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
Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline
- Tewameter Measurements at baseline and weeks 4, 8, and 12. A change in Tewameter values reflects an improvement in the barrier properties of the skin; an absence of a change in treated skin indicates mildness of the applied treatment.
Measured: 12 weeks
Stable skin pH during 12 week study
•pH Measurements at baseline and weeks 4, 8, and 12. A stable pH measurement reflects that the test product does not affect the overall cutaneous pH value.
Measured: 12 weeks
Improvement in Epidermal Thickness after 12 weeks versus baseline
•OCT Imaging Procedures at baseline and week 12, with image analysis performed at the end of the study using images from baseline and week 12. A change in epidermal thickness indicates improvement.
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 posted3 Jun 2021
- Study start11 Sep 2020
- Primary completion22 Dec 2020
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911374
- Sponsor's protocol ID
- C20-D134
- Status last verified
- Sep 2021
- First submitted
- 21 May 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging
- ClinicalTrials.gov ID
- NCT04911374
- Acronym / sponsor ID
- C20-D134
- Conditions
- Wrinkle, Photoaging, Fine Lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 3 Jun 2021 (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 single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.
Detailed description
This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.
Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.
A total of 42 subjects completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.
| Arm | Type | Receives |
|---|---|---|
| Anti-Aging Face Moisturizer and Eye Cream | Other | Other: Gentle Cleansing Lotion, Revision Skincare, Other: Aveeno Face Milk SPF 40+Dual Regimen: 1. Multi-ingredient anti-aging face moisturizer 2. Multi-ingredient anti-aging eye cream |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between the ages of 35 and 65 years
- Women with Fitzpatrick skin type I-VI
- Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent.
Key exclusion criteria (8 listed)
- Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
- Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
- Subjects that are unwilling to comply with the protocol
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
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 |
|---|---|---|
| Gentle Cleansing Lotion, Revision SkincareGentle cleansing lotion to be used by study participants | Other | Anti-Aging Face Moisturizer and Eye Cream |
| Aveeno Face Milk SPF 40+Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day. | Other | Anti-Aging Face Moisturizer and Eye Cream |
Primary outcome
Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline
Time frame: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 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.
Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time frame: 12 weeks
The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 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 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
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time frame: 12 weeks
Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline
Time frame: 12 weeks
Stable skin pH during 12 week study
Time frame: 12 weeks
Improvement in Epidermal Thickness after 12 weeks versus 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 6 Oct 2021.
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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 Gentle Cleansing Lotion, Revision Skincare and Aveeno Face Milk SPF 40+ in people with Wrinkle and Photoaging, 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 5 inclusion and 8 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 6 Oct 2021. 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?
Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks 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 6 Oct 2021.