HyperpigmentationNCT07501000
Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen
A study testing Brightening Treatment in people with Hyperpigmentation and Skin Ageing, run by Revision Skincare at 1 site in United States.
Trial summary
A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Skin Ageing, Post Inflammatory Hyperpigmentation
- What is being tested?
- Brightening Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 23 Jan 2025
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
- Individuals of Female biological sex.
- Individuals between 20 to 65 years of age.
- Individuals with Fitzpatrick skin types I - VI
- Individuals of any race or ethnicity.
- Individuals with moderate global facial Hyperpigmentation (score of 3 for darkness, and heterogeneity, and a score of 3 to 4 for area on the PIHASI scale).
- Individuals with self-perceived facial pigmentation.
Who cannot join
- Individuals currently participating in or has participated in any other clinical study involving the face at another research facility or doctor's office within the past one (1) month.
- Individuals with no self-perceived facial pigmentation.
- Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
- Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
- Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
- Individuals currently having or have a history of facial skin cancer within the past 5 years. Have or had cancer pertaining to any parts of the body and systems which in the opinion of the Investigator could interfere with the outcome of the study.
- Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Wellness Dermatology
Birmingham, Alabama, 35209
About this study
Official title: A Clinical Study to Evaluate the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen on Healthy Female Subjects.
A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.
Read the detailed description
A 12-week, single-center, open-label, clinical case study evaluating the efficacy and tolerability of a Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global face pigmentation when applied by a clinician in a series of 4 sessions at 2-week intervals.
At Visit 1 (Screening, Day -7), subjects will review and sign an Informed Consent Form (ICF) and photography release form. Subjects will then be screened for eligibility, and qualified subjects will commence a 7-day pre-treatment skincare regimen and be scheduled for the baseline visit. Subjects will be provided with the Gentle Foaming Cleanser, Vitamin C Serum, and a Broad-Spectrum Sunscreen SPF 50 to be used for the 7-day pre-treatment skincare regimen period along with skincare regimen instructions. Clinical assessments will be performed including Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, VISIA®-CR or Apple iPad Imaging, Antera® Imaging, and Self-Assessment Questionnaires.
At Visit 2 (Baseline, Day 0) if subjects continue to meet eligibility, then subjects will receive their 1st Brightening Treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will return to the clinical site to receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 layers, respectively). Various assessments will be performed before and after the procedure and will include Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, Subject Sensitivity Grading, Investigator Skin Frosting Evaluation, VISIA®-CR Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2, subjects will be provided with a Post Procedure Cream to use on Days 0, 1, and 2 post treatment. Subjects will continue to use Gentle Foaming Cleanser, Vitamin C Serum (starting on day 3), and Broad-Spectrum Sunscreen SPF 50 as the post-treatment skincare regimen. Subjects will be provided with skincare regimen instructions to be followed throughout the 12-week clinical study. To confirm compliance with usage, each container will be weighed on a scale at every visit and subjects will record topical usage in a daily diary.
At Visit 6 (week 12), subjects will return to the clinical site for follow-up clinical evaluations. The same assessments completed at previous visits will be repeated.
- Being tested
- Brightening Treatment
- Keywords
- brightening, dark spots, hyperpigmentation, pigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brightening TreatmentOther
Subjects will receive a brightening treatment at baseline, week 2, week 4, and week 6. At Baseline subjects will receive their 1st Brightening treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 Peel layers, respectively).
| Study group | Role | What they receive |
|---|---|---|
| Skincare Regimen | Experimental | 7 day washout period skincare regimen:
- Gentle foaming Cleanser twice daily, vitamin C serum twice daily, and Broad-Spectrum Sunscreen SPF 50 once daily.
12-Week skincare regimen: Subjects will be provided with a Gentle Foaming Cleanser, Post Procedure Cream, Vitamin C Serum, and a Broad-Spectrum sunscreen SPF 50 for at home use.
* Gentle Foaming Cleanser will be instructed to be used twice daily.
* Post Procedure Cream will be instructed to be used twice daily on days 0, 1, and 2 post treatment.
* Vitamin C Serum will be instructed to be used twice daily starting on Day 3 post treatment until the next clinic study visit.
* Sunscreen SPF 50 will be used after application as the last step in the skin care regimen in the morning. Sunscreen to be reapplied if continuous sun exposure occurs. Receives: Other: Brightening Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Investigator Clinical Grading
The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Grading of the appearance of global pigmentation due to sun exposure, blemishes, and/or procedures according to the Post-Inflammatory Hyperpigmentation Area and Severity Index (PIHASI) at weeks 2,4, 6, and 12 versus baseline. The PIHASI measures three pigment charactersitics: Darkness (Score 0 absent, 1 slight, 3 moderate, 4 maximum), Heterogeneity (Score 0 absent, 1 slight, 3 moderate, 4 maximum), and Area (score 0: 0%, 1: 1-9%, 2: 10 - 29%, 3: 30 - 49%), 4: 50 - 69%m 5: 70 - 89%, 6: 90 - 100%). A decrease in score / value indicates an improvement.
Measured: Baseline, weeks 2, 4, 6, and 12
Secondary outcomes (1)
Measurement of subject self assessment questionnaire
Subjects will complete a self-assessment questionnaire which will consist of a series of questions related to subjects' evaluation of product efficacy and attributes. 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: Visit 1, 2, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start7 Oct 2024
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT07501000
- Sponsor's protocol ID
- RS-2024-05
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen on Healthy Female Subjects.
- ClinicalTrials.gov ID
- NCT07501000
- Acronym / sponsor ID
- RS-2024-05
- Keywords
- brightening, dark spots, hyperpigmentation, pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 30 Mar 2026 (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.
A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.
Detailed description
A 12-week, single-center, open-label, clinical case study evaluating the efficacy and tolerability of a Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global face pigmentation when applied by a clinician in a series of 4 sessions at 2-week intervals.
At Visit 1 (Screening, Day -7), subjects will review and sign an Informed Consent Form (ICF) and photography release form. Subjects will then be screened for eligibility, and qualified subjects will commence a 7-day pre-treatment skincare regimen and be scheduled for the baseline visit. Subjects will be provided with the Gentle Foaming Cleanser, Vitamin C Serum, and a Broad-Spectrum Sunscreen SPF 50 to be used for the 7-day pre-treatment skincare regimen period along with skincare regimen instructions. Clinical assessments will be performed including Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, VISIA®-CR or Apple iPad Imaging, Antera® Imaging, and Self-Assessment Questionnaires.
At Visit 2 (Baseline, Day 0) if subjects continue to meet eligibility, then subjects will receive their 1st Brightening Treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will return to the clinical site to receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 layers, respectively). Various assessments will be performed before and after the procedure and will include Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, Subject Sensitivity Grading, Investigator Skin Frosting Evaluation, VISIA®-CR Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2, subjects will be provided with a Post Procedure Cream to use on Days 0, 1, and 2 post treatment. Subjects will continue to use Gentle Foaming Cleanser, Vitamin C Serum (starting on day 3), and Broad-Spectrum Sunscreen SPF 50 as the post-treatment skincare regimen. Subjects will be provided with skincare regimen instructions to be followed throughout the 12-week clinical study. To confirm compliance with usage, each container will be weighed on a scale at every visit and subjects will record topical usage in a daily diary.
At Visit 6 (week 12), subjects will return to the clinical site for follow-up clinical evaluations. The same assessments completed at previous visits will be repeated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skincare Regimen | Experimental | Other: Brightening Treatment7 day washout period skincare regimen: - Gentle foaming Cleanser twice daily, vitamin C serum twice daily, and Broad-Spectrum Sunscreen SPF 50 once daily. 12-Week skincare regimen: Subjects will be provided with a Gentle Foaming Cleanser, Post Procedure Cream, Vitamin C Serum, and a Broad-Spectrum sunscreen SPF 50 for at home use. * Gentle Foaming Cleanser will be instructed to be used twice daily. * Post Procedure Cream will be instructed to be used twice daily on days 0, 1, and 2 post treatment. * Vitamin C Serum will be instructed to be used twice daily starting on Day 3 post treatment until the next clinic study visit. * Sunscreen SPF 50 will be used after application as the last step in the skin care regimen in the morning. Sunscreen to be reapplied if continuous sun exposure occurs. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
- Individuals of Female biological sex.
- Individuals between 20 to 65 years of age.
- Individuals with Fitzpatrick skin types I - VI
- Individuals of any race or ethnicity.
Key exclusion criteria (7 listed)
- Individuals currently participating in or has participated in any other clinical study involving the face at another research facility or doctor's office within the past one (1) month.
- Individuals with no self-perceived facial pigmentation.
- Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
- Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
- Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
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 |
|---|---|---|
| Brightening TreatmentSubjects will receive a brightening treatment at baseline, week 2, week 4, and week 6. At Baseline subjects will receive their 1st Brightening treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 Peel layers, respectively). | Other | Skincare Regimen |
Primary outcome
Measurement of Investigator Clinical Grading
Time frame: Baseline, weeks 2, 4, 6, and 12
The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Grading of the appearance of global pigmentation due to sun exposure, blemishes, and/or procedures according to the Post-Inflammatory Hyperpigmentation Area and Severity Index (PIHASI) at weeks 2,4, 6, and 12 versus baseline. The PIHASI measures three pigment charactersitics: Darkness (Score 0 absent, 1 slight, 3 moderate, 4 maximum), Heterogeneity (Score 0 absent, 1 slight, 3 moderate, 4 maximum), and Area (score 0: 0%, 1: 1-9%, 2: 10 - 29%, 3: 30 - 49%), 4: 50 - 69%m 5: 70 - 89%, 6: 90 - 100%). A decrease in score / value indicates an improvement.
1 secondary outcome
Measurement of subject self assessment questionnaire
Time frame: Visit 1, 2, 3, and 6
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 5 Jun 2026.
- 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 Brightening Treatment in people with Hyperpigmentation and Skin Ageing, 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 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 5 Jun 2026. 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?
Measurement of Investigator Clinical Grading (time frame: Baseline, weeks 2, 4, 6, and 12). 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 5 Jun 2026.