AcnePhase 2NCT05327361
LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)
A Phase 2 study testing Liftactiv B3 and Sunscreen in people with Acne and Post Inflammatory Hyperpigmentation, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation) Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acne, Post Inflammatory Hyperpigmentation
- What is being tested?
- Liftactiv B3 and Sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 6 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiethnic subjects
- 18 to 50 YO
- Phototype III-VI
- All skin types
- 50% with sensitive skin (declarative)
- Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale
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- Mild active acne (less than 10 retention and 5 inflammatory lesions)
- Agreeing not to change their lifestyle during the study period.
- Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.
- Available to follow the study
- Agreeing to participate and having signed the informed consent
Who cannot join
- Moderate to severe active acne
- Patients under topical or systemic retinoids
- Patients under systemic immunosuppressants
- Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
- Patients treated with facial procedures within the last 3 months
- Pregnancy
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- Patient with a recent change in contraception (since less than 6 months)
- Known allergy to any component of tested product
- Not presenting with the conditions needed to comply with the protocol.
- Unable to give their informed consent
- Not available to follow the study in its entirety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months
The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)
- Conditions
- Acne, Post Inflammatory Hyperpigmentation
- Being tested
- Liftactiv B3, Sunscreen
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liftactiv B3Drug
Participants will apply a dime size amount of the serum to 1 side of the face.
SunscreenOther
Participants will apply a dime size amount of sunscreen to cover the other half of the face.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Receives: Other: Sunscreen |
| Liftactiv B3 | Experimental | Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Receives: Drug: Liftactiv B3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Inflammatory Hyperpigmentation (PIHP) Change
Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale.
The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.
Measured: Baseline, 1 month, 2 months and 3 months
Secondary outcomes (6)
Change in the Investigators Global Assessment (IGA) Scale
Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as clear is 0, almost clear is 1, mild is 2, moderate is 3, severe is 4, and every severe is 5 within the treatment area.
Measured: Baseline, 1 month, 2 months and 3 months
Change in Skin Condition Evaluation Scores
Clinical evaluation of skin condition on subject's face which includes deep wrinkles, fine lines, skin tone, skin texture, radiance and skin elasticity will be evaluated using a 10 point Likert Scale. Each of these conditions will use the same Likert Scale from 0 to 9 with the higher score indicating more severe/worse symptoms.
Measured: Baseline, 1 month, 2 months and 3 months
Change in Global Efficacy Assessment
Global efficacy of the treatment evaluated at each visit by the patient.
The measure of the global efficacy will be realized according to the Global efficacy scale which ranges from nil to excellent which will be measured from 0 (equals nil) to 4 (equals excellent).
Measured: 1 month, 2 months, and 3 months
Change in Global Tolerance Score
Clinical tolerance global score will be assessed, on the treated area, at each visit using first a 4-point skin reaction scale which ranges from 0 which indicates no evidence of local intolerance and 4 indicates very severe signs or symptoms of intolerance.
Measured: 1 month, 2 months, and 3 months
Change in Cosmeticity Questionnaire and Acceptability
Subjects will be questioned about their perceived effects of the investigational product on their skin.
The cosmeticity questionnaire is a 5 point scale (1-fully disagree; 2-disagree partly; 3-no opinion; 4-agree partly; 5-fully agree).
Measured: 1 month, 2 months, and 3 months
Exposome Questionnaire
Subjects will be questioned about environmental influences. Count of participants completing questionnaire.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start22 Mar 2022
- Primary completion17 Jan 2023
- Study completion6 Mar 2023
Why it stopped: Enrollment timeline ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcneStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Vichy Laboratoires
- Responsible party
- Principal investigator, Leigh Nattkemper, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327361
- Sponsor's protocol ID
- 20211099
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2022
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months
- ClinicalTrials.gov ID
- NCT05327361
- Acronym / sponsor ID
- 20211099
- Conditions
- Acne, Post Inflammatory Hyperpigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment timeline ended
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Vichy Laboratoires
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: SunscreenParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. |
| Liftactiv B3 | Experimental | Drug: Liftactiv B3Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Multiethnic subjects
- 18 to 50 YO
- Phototype III-VI
- All skin types
- 50% with sensitive skin (declarative)
Key exclusion criteria (11 listed)
- Moderate to severe active acne
- Patients under topical or systemic retinoids
- Patients under systemic immunosuppressants
- Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
- Patients treated with facial procedures within the last 3 months
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 |
|---|---|---|
| Liftactiv B3Participants will apply a dime size amount of the serum to 1 side of the face. | Drug | Liftactiv B3 |
| SunscreenParticipants will apply a dime size amount of sunscreen to cover the other half of the face. | Other | Control Group |
Primary outcome
Post Inflammatory Hyperpigmentation (PIHP) Change
Time frame: Baseline, 1 month, 2 months and 3 months
Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.
6 secondary outcomes
Change in the Investigators Global Assessment (IGA) Scale
Time frame: Baseline, 1 month, 2 months and 3 months
Change in Skin Condition Evaluation Scores
Time frame: Baseline, 1 month, 2 months and 3 months
Change in Global Efficacy Assessment
Time frame: 1 month, 2 months, and 3 months
Change in Global Tolerance Score
Time frame: 1 month, 2 months, and 3 months
Change in Cosmeticity Questionnaire and Acceptability
Time frame: 1 month, 2 months, and 3 months
Exposome Questionnaire
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Phase 2 study testing Liftactiv B3 and Sunscreen in people with Acne and Post Inflammatory Hyperpigmentation, run by University of Miami 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Apr 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Inflammatory Hyperpigmentation (PIHP) Change (time frame: Baseline, 1 month, 2 months and 3 months). 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 3 Apr 2024.