HyperpigmentationNCT05423873
A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of Aging
A study testing Gentle Cleansing Lotion, Revision Skincare in people with Hyperpigmentation and Photodamaged Skin, run by Revision Skincare at 3 sites in United States.
Trial summary
This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. 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
- Hyperpigmentation, Photodamaged Skin, Wrinkle
- What is being tested?
- Gentle Cleansing Lotion, Revision Skincare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2021to 10 Feb 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
- Women between the ages of 35 and 60 years old.
- Women with Fitzpatrick skin type I-V.
- Subjects must have moderate to severe global face hyperpigmentation.
- Subjects must have moderate global face 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 are unwilling to comply with the protocol.
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects who have a history of skin cancer.
- Subjects who have observable suntan, sunburn, scars, nevi, tattoo, excess hair, etc. or other dermatological condition on the face that might influence the test results in the opinion of the investigator.
- Subjects who have routinely used any anti-aging, anti-wrinkles, antioxidants treatments and skin-firming products less than 30 days prior to the study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
About Skin
Greenwood Village, Colorado, 80111
Brian S. Biesman, M.D.
Nashville, Tennessee, 37203
Art of Skin MD
Solana Beach, California, 92075
About this study
Official title: A Multi-Center Clinical Trial to Evaluate the Efficacy and Tolerability for Treatment of Facial Hyperpigmentation and Photodamaged Skin With a Dual Regimen Treatment Containing Vitamin C and a Tinted SPF 45 Moisturizer
This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. A total of 33 subjects completed study participation.
Read the detailed description
This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with Fitzpatrick skin type I - V, moderate to severe global face hyperpigmentation and moderate global face photodamage.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject testimonials will be completed at week 12.
A total of 33 subjects completed study participation.
- Conditions
- Hyperpigmentation, Photodamaged Skin, Wrinkle, Fine Lines
- Being tested
- Gentle Cleansing Lotion, Revision Skincare
- Keywords
- Vitamin C, Sunscreen, Pollution, Solar Radiation
- Medical subject headings
- Hyperpigmentation
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 twice daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C Serum and Moisturizing Sunscreen SPF 45 | Other | Dual Regimen:
Vitamin C Serum Tinted Moisturizing Sunscreen SPF 45 Receives: Other: Gentle Cleansing Lotion, Revision Skincare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in clinical efficacy of hyperpigmentation 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.
Global facial hyperpigmentation will be assessed 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 Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
The primary tolerability endpoint will be favorable analysis of 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:
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
Measured: 12 weeks
Incidence and severity of adverse events
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects through-out the length of the study.
Measured: 12 weeks
Secondary outcomes (2)
Improvement in clinical efficacy of photodamage versus Baseline
The secondary 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.
Global facial photodamage will be assessed 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 Subject Tolerability Parameters at week 4, 8, 12
The primary tolerability endpoint will be favorable analysis of the Subject 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
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 posted21 Jun 2022
- Study start17 Mar 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Multi-Center, Open-Label 33 female subjects between 35 to 60 years old with Fitzpatrick skin type I-V, moderate to severe global face hyperpigmentation, and moderate global face photodamage. Washout period of 2 weeks refraining from active antiaging topical products, including vitamin C, retinoids, peptides, and growth factors.
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT05423873
- Sponsor's protocol ID
- RS-2020-04
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hooper D, Tedaldi R, Iglesia S, Young MB, Kononov T, Zahr AS. Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. J Clin Aesthet Dermatol. 2023 Oct;16(10):31-38.
PubMed 37915337
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Clinical Trial to Evaluate the Efficacy and Tolerability for Treatment of Facial Hyperpigmentation and Photodamaged Skin With a Dual Regimen Treatment Containing Vitamin C and a Tinted SPF 45 Moisturizer
- ClinicalTrials.gov ID
- NCT05423873
- Acronym / sponsor ID
- RS-2020-04
- Conditions
- Hyperpigmentation, Photodamaged Skin, Wrinkle, Fine Lines
- Keywords
- Vitamin C, Sunscreen, Pollution, Solar Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 21 Jun 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 open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. A total of 33 subjects completed study participation.
Detailed description
This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with Fitzpatrick skin type I - V, moderate to severe global face hyperpigmentation and moderate global face photodamage.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject testimonials will be completed at week 12.
A total of 33 subjects completed study participation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Multi-Center, Open-Label 33 female subjects between 35 to 60 years old with Fitzpatrick skin type I-V, moderate to severe global face hyperpigmentation, and moderate global face photodamage. Washout period of 2 weeks refraining from active antiaging topical products, including vitamin C, retinoids, peptides, and growth factors.
| Arm | Type | Receives |
|---|---|---|
| Vitamin C Serum and Moisturizing Sunscreen SPF 45 | Other | Other: Gentle Cleansing Lotion, Revision SkincareDual Regimen: Vitamin C Serum Tinted Moisturizing Sunscreen SPF 45 |
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 old.
- Women with Fitzpatrick skin type I-V.
- Subjects must have moderate to severe global face hyperpigmentation.
- Subjects must have moderate global face photodamage.
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
Key exclusion criteria (7 listed)
- Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face.
- Subjects that are unwilling to comply with the protocol.
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects who have a history of skin cancer.
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 twice daily | Other | Vitamin C Serum and Moisturizing Sunscreen SPF 45 |
Primary outcome
Improvement in clinical efficacy of hyperpigmentation 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. Global facial hyperpigmentation will be assessed 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 Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
Time frame: 12 weeks
The primary tolerability endpoint will be favorable analysis of 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: 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
Incidence and severity of adverse events
Time frame: 12 weeks
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects through-out the length of the study.
2 secondary outcomes
Improvement in clinical efficacy of photodamage versus Baseline
Time frame: 12 weeks
Lack of Significant Increase in Objective Subject Tolerability Parameters at week 4, 8, 12
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 21 Jun 2022.
- Derived from this study: PubMed 37915337Hooper D, Tedaldi R, Iglesia S, Young MB, Kononov T, Zahr AS. Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. J Clin Aesthet Dermatol. 2023 Oct;16(10):31-38.
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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.
3 sites 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 in people with Hyperpigmentation and Photodamaged Skin, run by Revision Skincare at 3 sites 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 in clinical efficacy of hyperpigmentation 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?
On the ClinicalTrials.gov record for NCT05423873, which also lists 1 linked publication.
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 21 Jun 2022.