Periorbital HyperpigmentationNCT05807620
A 12 Week Study to Evaluate the Efficacy of an Eye Cream
A study testing Gentle Cleansing Lotion, Facial Moisturizer and Sunscreen SPF 30 in people with Periorbital Hyperpigmentation and Periorbital Edema, run by Revision Skincare at 1 site in United States.
Trial summary
This single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. 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
- Periorbital Hyperpigmentation, Periorbital Edema, Fine Lines
- What is being tested?
- Gentle Cleansing Lotion, Facial Moisturizer and Sunscreen SPF 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jul 2022
- 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
- Females in good general health
- With Fitzpatrick Skin Type I - VI
- Moderate to severe under eye dark circles
- Moderate undereye puffiness
- Mild to moderate fine lines and wrinkles
Who cannot join
- Subjects who have used retinol or eye cream / serum 7 days prior to study commencement
- Nursing, pregnant, or planning a pregnancy during this study
- Having a health condition and / or pre-existing or dormant dermatologic disease on the face
Trial locations and contacts
1 site in 1 country.
United States1 site
Validated Claim Support, LLC
Teaneck, New Jersey, 07666
About this study
Official title: A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness
This single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. A total of 37 subjects were enrolled into the study.
Read the detailed description
This single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness. This study aims to evaluate the following objectives:
- To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12.
- To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12.
- To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12.
A total of 37 subjects completed the study.
- Conditions
- Periorbital Hyperpigmentation, Periorbital Edema, Fine Lines, Wrinkle
- Being tested
- Gentle Cleansing Lotion, Facial Moisturizer, Sunscreen SPF 30
- Keywords
- dark circles, puffiness, brightening
- Medical subject headings
- Orbital Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Cleansing LotionOther
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Facial MoisturizerOther
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).
Sunscreen SPF 30Other
Neutrogena Ultra Sheer Dry Touch SPF 30. 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 |
|---|---|---|
| Eye Cream | Experimental | Eye Cream composed of botanical extracts, bioavailable peptides, THD Ascorbate and Caffeine.
Subjects to apply a dime size amount onto the under-eye area and crow's feet area while avoiding direct eye contact twice daily for the duration of the 12-week clinical study. Receives: Other: Gentle Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator Clinical Grading versus Baseline
The primary efficacy endpoint will be investigator clinical grading using a Modified Griffiths 10 point scale and a validated photonumeric scale for undereye dark circles
A decrease in scores at post baseline timepoints (weeks 4, 8, and 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 validated photonumeric scale for dark circles and 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
Bioinstrumentation: Laser Doppler
Bioinstrumentation measurements includes INL 191 Blood FlowMeter laser doppler
A standard surface probe approximately 17mm in diameter was placed on the right or left undereye area per randomization and measurements in perfusion units (AU) were obtained at baseline week 8 and week 12.
An increase in AU values indicates an improvement in dark circles
Measured: 12 weeks
Bioinstrumentation: Chromameter
Bioinstrumentation measurements includes Chroma Meter CR-200 (Konica Minolta, Tokyo, JPN)
Measurements were taken on the right or left undereye area, per randomization on each subject in triplicate and averaged at baseline, week 4, 8 and 12. Three color value characteristics are evaluated: L* (100 = white, 0 = black) and a* (red-green)
An increase in L* indicates an improvement A decrease in a* indicates an improvement
Measured: 12 weeks
Secondary outcomes (2)
Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 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. Five point scale with a lower score indicating a better outcome.
Example for Erythema: Erythema 0 = None No erythema of the treatment area
- = very slight erythema (barely perceptible)
- = well-defined erythema
- = Moderate to severe erythema
- = Severe erythema (beet redness) to slight eschar formation
Measured: 12 weeks
Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 12 compared to baseline
The secondary tolerability endpoint will be the Subjective Tolerability Assessment of Stinging, Tingling, Itching, and Burning
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
- = Mild
- = Moderate
- = Severe
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 Apr 2023
- Study start1 Jan 2022
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital HyperpigmentationStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Validated Claim Support
- Responsible party
- Sponsor
- Investigators
- Anna Hardy, Study director, Validated Claim Support
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807620
- Sponsor's protocol ID
- CS211024
- Status last verified
- Nov 2023
- First submitted
- 20 Mar 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness
- ClinicalTrials.gov ID
- NCT05807620
- Acronym / sponsor ID
- CS211024
- Conditions
- Periorbital Hyperpigmentation, Periorbital Edema, Fine Lines, Wrinkle
- Keywords
- dark circles, puffiness, brightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Validated Claim Support
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 11 Apr 2023 (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, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. A total of 37 subjects were enrolled into the study.
Detailed description
This single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness. This study aims to evaluate the following objectives:
- To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12.
- To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12.
- To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12.
A total of 37 subjects completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye Cream | Experimental | Other: Gentle Cleansing Lotion, Other: Facial Moisturizer, Other: Sunscreen SPF 30Eye Cream composed of botanical extracts, bioavailable peptides, THD Ascorbate and Caffeine. Subjects to apply a dime size amount onto the under-eye area and crow's feet area while avoiding direct eye contact twice daily for the duration of the 12-week clinical study. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females in good general health
- With Fitzpatrick Skin Type I - VI
- Moderate to severe under eye dark circles
- Moderate undereye puffiness
- Mild to moderate fine lines and wrinkles
Key exclusion criteria (3 listed)
- Subjects who have used retinol or eye cream / serum 7 days prior to study commencement
- Nursing, pregnant, or planning a pregnancy during this study
- Having a health condition and / or pre-existing or dormant dermatologic disease on the face
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 LotionFacial cleansing lotion to be used by study participants (morning and evening, 2x daily). | Other | Eye Cream |
| Facial MoisturizerAnti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily). | Other | Eye Cream |
| Sunscreen SPF 30Neutrogena Ultra Sheer Dry Touch SPF 30. 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 | Eye Cream |
Primary outcome
Change in Investigator Clinical Grading versus Baseline
Time frame: 12 weeks
The primary efficacy endpoint will be investigator clinical grading using a Modified Griffiths 10 point scale and a validated photonumeric scale for undereye dark circles A decrease in scores at post baseline timepoints (weeks 4, 8, and 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 validated photonumeric scale for dark circles and 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.
Bioinstrumentation: Laser Doppler
Time frame: 12 weeks
Bioinstrumentation measurements includes INL 191 Blood FlowMeter laser doppler A standard surface probe approximately 17mm in diameter was placed on the right or left undereye area per randomization and measurements in perfusion units (AU) were obtained at baseline week 8 and week 12. An increase in AU values indicates an improvement in dark circles
Bioinstrumentation: Chromameter
Time frame: 12 weeks
Bioinstrumentation measurements includes Chroma Meter CR-200 (Konica Minolta, Tokyo, JPN) Measurements were taken on the right or left undereye area, per randomization on each subject in triplicate and averaged at baseline, week 4, 8 and 12. Three color value characteristics are evaluated: L* (100 = white, 0 = black) and a* (red-green) An increase in L* indicates an improvement A decrease in a* indicates an improvement
2 secondary outcomes
Lack of significant increase in objective investigator tolerability parameters at week 4, 8, and 12 compared to baseline
Time frame: 12 weeks
Lack of significant increase in Subjective investigator tolerability parameters at week 4, 8, and 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 30 Nov 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Related trials for Periorbital Hyperpigmentation
Active, not recruiting
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Melasma, Rosacea
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.
Anna Hardy study director
Validated Claim Support
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, Facial Moisturizer and Sunscreen SPF 30 in people with Periorbital Hyperpigmentation and Periorbital Edema, 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 3 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 30 Nov 2023. 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?
Change in Investigator Clinical Grading versus Baseline (time frame: 12 weeks). The study lists 3 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 30 Nov 2023.