Post-inflammatory HyperpigmentationNCT07896486
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
A study testing Vinoperfect brightening serum in people with Post-inflammatory Hyperpigmentation and Post-acne Hyperpigmentation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness and safety of Vinoperfect, a skin-brightening serum, for treating post-inflammatory hyperpigmentation (PIH), or dark spots that can develop after acne, in participants with Fitzpatrick Skin Types IV-VI (medium to deep skin tones). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
- What is being tested?
- Vinoperfect brightening serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged ≥18 years.
- Participants with Fitzpatrick Skin Types IV, V, or VI.
- Participants of any ethnicity.
- Presenting with moderate to severe post-inflammatory hyperpigmentation, as determined by a PAHPI score of 8 or higher.
- Presenting with history or presence of mild acne, as indicated by a Global Acne Severity Score of 2 or lower (GEA ≤ 2).
- Capable of understanding and communicating in English, and willing to provide written informed consent to participate in the study.
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- Willing to comply with study requirements, including attending all scheduled in-person follow-up visits as outlined in the protocol.
- Willing to undergo facial photography.
- Willing to undergo facial examination for clinical evaluation.
- In good general health, free of any other dermatologic conditions that may interfere with the assessment of the treated area.
- Willing to refrain from using any other facial skincare products during the study period.
- Willing to avoid excessive sun exposure and tanning beds during the study period.
- Willing to refrain from undergoing chemical peels, laser rejuvenation, or hair removal treatments during the study period.
- For females of childbearing potential: willing to use at least one reliable form of contraception, defined as stable use of oral or systemic contraceptives for at least 6 months prior to Day 1 of the study and throughout the study duration.
Who cannot join
- Participants with Fitzpatrick Skin Types I, II, or III.
- Pregnant or breastfeeding participants.
- Individuals presenting with moderate to very severe acne, as indicated by a Global Acne Severity Score of 3 or higher (GEA > 3).
- Participants with known allergies or sensitivities to any active or inactive ingredients in the study products.
- Participants with dermatologic conditions that may interfere with the evaluation of the treatment area.
- Individuals with regular sun exposure or frequent use of tanning salons.
- Participants currently enrolled in another clinical study.
- Participants who have used the following treatments or procedures within a specific washout periods (to be discussed with the study investigators).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine Dermatology
New York, New York, 10022
Angelica Nazarian, MD, 6469622090, dermres@med.cornell.edu
Olumayowa Adebiyi, MD, MHS, 6469626054, dermres@med.cornell.edu
About this study
Official title: A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
This study is designed to evaluate the effectiveness and safety of Vinoperfect, a skin-brightening serum, for treating post-inflammatory hyperpigmentation (PIH), or dark spots that can develop after acne, in participants with Fitzpatrick Skin Types IV-VI (medium to deep skin tones). The study will assess Vinoperfect as part of a comprehensive skincare routine that includes cleansing, treatment, moisturization, and protection from sunlight.
Read the detailed description
This is a single-center, open-label trial designed to assess the efficacy and tolerability of a skin brightening serum in individuals with skin of color who are diagnosed with acne-induced Post-Inflammatory Hyperpigmentation on the facial skin. The study will be conducted at a single site, enrolling male and female participants from a range of ethnic/racial backgrounds, all with Fitzpatrick Skin Types IV-VI. Study participation will last for 12 weeks.
- Being tested
- Vinoperfect brightening serum
- Keywords
- Post-Inflammatory Hyperpigmentation, post-acne hyperpigmentation, acne, hyperpigmentation, skin of color, FST
- Medical subject headings
- Hyperpigmentation, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinoperfect brightening serumOther
Participants will undergo a standardized twice-daily skincare regimen for 12 weeks. In the morning, participants will cleanse their face, apply the Vinoperfect Brightening Serum, apply moisturizer, and then apply SPF 50+ sunscreen. In the evening, participants will cleanse their face, apply the Vinoperfect Brightening Serum, and apply moisturizer.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Acne-Associated Post-Inflammatory Hyperpigmentation using the Vinoperfect Serum | Other | Participants will undergo a standardized twice-daily skincare regimen for 12 weeks. In the morning, participants will cleanse their face, apply the Vinoperfect Brightening Serum, apply moisturizer, and then apply SPF 50+ sunscreen. In the evening, participants will cleanse their face, apply the Vinoperfect Brightening Serum, and apply moisturizer. Receives: Other: Vinoperfect brightening serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PIH of the face at Week 12, as assessed by the Post-Acne Hyperpigmentation Index (PAHPI) score
Total scores on the PAHPI range from 6 to 22, with higher scores indicating greater severity of post-acne hyperpigmentation
Measured: Baseline; 12 weeks
Secondary outcomes (2)
Number or participants who tolerated the investigational product as assessed by the investigator
Investigator-assessed tolerability of the investigational product based on the presence and severity of local or systemic adverse reactions potentially attributable to the investigational product.
Measured: Up to 12 weeks
Patient-reported stigmatization, as measured by the PUSH-D questionnaire at week 12
Change from baseline in Patient-Reported Stigmatization, as measured by the PUSH-D (Patient Use and Satisfaction with Hyperpigmentation Dermocosmetic) questionnaire at Week 12. The PUSH-D is a 17-item patient-reported questionnaire assessing felt and enacted stigma associated with visible skin conditions. Total score range from 0 to 68 with higher scores indicating more felt/perceived stigma.
Measured: Baseline; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-inflammatory 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Caudalie
- Responsible party
- Sponsor
- Investigators
- Andrew Alexis, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896486
- Sponsor's protocol ID
- 26-01029789
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
- ClinicalTrials.gov ID
- NCT07896486
- Acronym / sponsor ID
- 26-01029789
- Keywords
- Post-Inflammatory Hyperpigmentation, post-acne hyperpigmentation, acne, hyperpigmentation, skin of color, FST
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Caudalie
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 Oct 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.
This study is designed to evaluate the effectiveness and safety of Vinoperfect, a skin-brightening serum, for treating post-inflammatory hyperpigmentation (PIH), or dark spots that can develop after acne, in participants with Fitzpatrick Skin Types IV-VI (medium to deep skin tones). The study will assess Vinoperfect as part of a comprehensive skincare routine that includes cleansing, treatment, moisturization, and protection from sunlight.
Detailed description
This is a single-center, open-label trial designed to assess the efficacy and tolerability of a skin brightening serum in individuals with skin of color who are diagnosed with acne-induced Post-Inflammatory Hyperpigmentation on the facial skin. The study will be conducted at a single site, enrolling male and female participants from a range of ethnic/racial backgrounds, all with Fitzpatrick Skin Types IV-VI. Study participation will last for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Acne-Associated Post-Inflammatory Hyperpigmentation using the Vinoperfect Serum | Other | Other: Vinoperfect brightening serumParticipants will undergo a standardized twice-daily skincare regimen for 12 weeks. In the morning, participants will cleanse their face, apply the Vinoperfect Brightening Serum, apply moisturizer, and then apply SPF 50+ sunscreen. In the evening, participants will cleanse their face, apply the Vinoperfect Brightening Serum, and apply moisturizer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female participants aged ≥18 years.
- Participants with Fitzpatrick Skin Types IV, V, or VI.
- Participants of any ethnicity.
- Presenting with moderate to severe post-inflammatory hyperpigmentation, as determined by a PAHPI score of 8 or higher.
- Presenting with history or presence of mild acne, as indicated by a Global Acne Severity Score of 2 or lower (GEA ≤ 2).
Key exclusion criteria (8 listed)
- Participants with Fitzpatrick Skin Types I, II, or III.
- Pregnant or breastfeeding participants.
- Individuals presenting with moderate to very severe acne, as indicated by a Global Acne Severity Score of 3 or higher (GEA > 3).
- Participants with known allergies or sensitivities to any active or inactive ingredients in the study products.
- Participants with dermatologic conditions that may interfere with the evaluation of the treatment area.
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 |
|---|---|---|
| Vinoperfect brightening serumParticipants will undergo a standardized twice-daily skincare regimen for 12 weeks. In the morning, participants will cleanse their face, apply the Vinoperfect Brightening Serum, apply moisturizer, and then apply SPF 50+ sunscreen. In the evening, participants will cleanse their face, apply the Vinoperfect Brightening Serum, and apply moisturizer. | Other | Participants with Acne-Associated Post-Inflammatory Hyperpigmentation using the Vinoperfect Serum |
Primary outcome
Change from baseline in PIH of the face at Week 12, as assessed by the Post-Acne Hyperpigmentation Index (PAHPI) score
Time frame: Baseline; 12 weeks
Total scores on the PAHPI range from 6 to 22, with higher scores indicating greater severity of post-acne hyperpigmentation
2 secondary outcomes
Number or participants who tolerated the investigational product as assessed by the investigator
Time frame: Up to 12 weeks
Patient-reported stigmatization, as measured by the PUSH-D questionnaire at week 12
Time frame: Baseline; Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
Andrew Alexis, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vinoperfect brightening serum in people with Post-inflammatory Hyperpigmentation and Post-acne Hyperpigmentation, run by Weill Medical College of Cornell University 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 14 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: opening soon, as of the sponsor's last update on 30 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Alexis, MD, MPH (6469623376, dermres@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in PIH of the face at Week 12, as assessed by the Post-Acne Hyperpigmentation Index (PAHPI) score (time frame: Baseline; 12 weeks). 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 Oct 2026.