Fine LinesNCT04545970
A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines
A study testing Facial cleanser, Facial moisturizer and Sunscreen in people with Fine Lines and Wrinkles, run by Revision Skincare at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fine Lines, Wrinkles, Photoaging
- What is being tested?
- Facial cleanser, Facial moisturizer and Sunscreen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2019to 6 Jul 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
- Women with Fitzpatrick Skin Type I-VI
- Subjects must have mild to moderate global face wrinkles and fine lines
- Subjects may have mild to moderate photo-aging secondary to physiologic aging
- 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
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage as determined by the Investigator.
- 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.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ablon Skin Institute Research Center
Manhattan Beach, California, 90266
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
Read the detailed description
This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.
Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.
A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
- Conditions
- Fine Lines, Wrinkles, Photoaging
- Being tested
- Facial cleanser, Facial moisturizer, Sunscreen
- Keywords
- anti-aging, serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial cleanserCombination product
Facial cleanser to be used by study participants
Facial moisturizerCombination product
Bland moisturizer to be used by study participants after serum in the evening.
SunscreenCombination product
Also called Neutrogena Sheer Zinc SPF 30
Sunscreen to be applied after application of serum in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Anti-aging Serum | Active comparator | Dosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides.
Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.
Study Duration: 12 weeks. Receives: Combination Product: Facial cleanser; Combination Product: Facial moisturizer; Combination Product: Sunscreen |
| Placebo Serum | Placebo comparator | Dosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.
Study Duration: 12 weeks. Receives: Combination Product: Facial cleanser; Combination Product: Facial moisturizer; Combination Product: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy Graded by Griffiths' Scale
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 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
Objective Tolerability: scores
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 28, Day 56 and Day 84 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 (2)
Subjective Tolerability: scores
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 28, Day 56 and Day 84 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
Self Assessment Questions
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 28, Day 56 and Day 84 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: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start23 Dec 2019
- Primary completion11 Mar 2020
- Study completion6 Jul 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, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ablon Skin Institute Research Center
- Responsible party
- Sponsor
- Investigators
- Glynis Ablon, MD, FAAD, Principal investigator, Ablon Skin Institute Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545970
- Sponsor's protocol ID
- ASIRC-RS-01
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 16 Sep 2020
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
- ClinicalTrials.gov ID
- NCT04545970
- Acronym / sponsor ID
- ASIRC-RS-01
- Conditions
- Fine Lines, Wrinkles, Photoaging
- Keywords
- anti-aging, serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Ablon Skin Institute Research Center
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 11 Sep 2020 (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 randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
Detailed description
This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.
Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.
A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
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, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Anti-aging Serum | Active comparator | Combination Product: Facial cleanser, Combination Product: Facial moisturizer, Combination Product: SunscreenDosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks. |
| Placebo Serum | Placebo comparator | Combination Product: Facial cleanser, Combination Product: Facial moisturizer, Combination Product: SunscreenDosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
- Women with Fitzpatrick Skin Type I-VI
- Subjects must have mild to moderate global face wrinkles and fine lines
- Subjects may have mild to moderate photo-aging secondary to physiologic aging
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
Key exclusion criteria (7 listed)
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage as determined by the Investigator.
- 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.
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 |
|---|---|---|
| Facial cleanserFacial cleanser to be used by study participants | Combination product | Anti-aging Serum, Placebo Serum |
| Facial moisturizerBland moisturizer to be used by study participants after serum in the evening. | Combination product | Anti-aging Serum, Placebo Serum |
| SunscreenAlso: Neutrogena Sheer Zinc SPF 30Sunscreen to be applied after application of serum in the morning. | Combination product | Anti-aging Serum, Placebo Serum |
Primary outcome
Clinical Efficacy Graded by Griffiths' Scale
Time frame: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 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.
Objective Tolerability: scores
Time frame: 12 weeks
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 28, Day 56 and Day 84 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
2 secondary outcomes
Subjective Tolerability: scores
Time frame: 12 weeks
Self Assessment Questions
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 16 Sep 2020.
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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.
Glynis Ablon, MD, FAAD principal investigator
Ablon Skin Institute Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial cleanser, Facial moisturizer and Sunscreen in people with Fine Lines and Wrinkles, 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 6 inclusion and 7 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 16 Sep 2020. 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?
Clinical Efficacy Graded by Griffiths' Scale (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 16 Sep 2020.