Acne, Post Inflammatory Hyperpigmentation
Conditions
Brief 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)
Interventions
DRUGLiftactiv B3
Participants will apply a dime size amount of the serum to 1 side of the face.
OTHERSunscreen
Participants will apply a dime size amount of sunscreen to cover the other half of the face.
Sponsors
Vichy Laboratoires
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Inflammatory Hyperpigmentation (PIHP) Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Condition Evaluation Scores | Baseline, 1 month, 2 months and 3 months | 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. |
| Change in Global Efficacy Assessment | 1 month, 2 months, and 3 months | 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). |
| Change in the Investigators Global Assessment (IGA) Scale | Baseline, 1 month, 2 months and 3 months | 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. |
| Change in Cosmeticity Questionnaire and Acceptability | 1 month, 2 months, and 3 months | 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). |
| Exposome Questionnaire | Baseline and 3 months | Subjects will be questioned about environmental influences. Count of participants completing questionnaire. |
| Change in Global Tolerance Score | 1 month, 2 months, and 3 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Every participant enrolled (total 13) received each arm of the study with treatment arm on one side of the face, and the control arm on the other side of the face (which equates to 26 participants total for the arms/groups).
Participants by arm
| Arm | Count |
|---|---|
| Liftactiv B3 and Control Group 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.
Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.will apply a dime size amount of sunscreen to cover the other half of the face. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Liftactiv B3 and Control Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
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.
Time frame: Baseline, 1 month, 2 months and 3 months
Population: Only 9 participants completed the the follow up (1 month, 2 month, and 3 month) visit assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Post Inflammatory Hyperpigmentation (PIHP) Change | Baseline | 8.25 score on a scale | Standard Deviation 2.38 |
| Control Group | Post Inflammatory Hyperpigmentation (PIHP) Change | 1 month | 6.56 score on a scale | Standard Deviation 1.13 |
| Control Group | Post Inflammatory Hyperpigmentation (PIHP) Change | 2 months | 6.44 score on a scale | Standard Deviation 1.33 |
| Control Group | Post Inflammatory Hyperpigmentation (PIHP) Change | 3 months | 6 score on a scale | Standard Deviation 0 |
| Liftactiv B3 | Post Inflammatory Hyperpigmentation (PIHP) Change | 3 months | 6 score on a scale | Standard Deviation 0 |
| Liftactiv B3 | Post Inflammatory Hyperpigmentation (PIHP) Change | Baseline | 8.25 score on a scale | Standard Deviation 2.37 |
| Liftactiv B3 | Post Inflammatory Hyperpigmentation (PIHP) Change | 2 months | 6.44 score on a scale | Standard Deviation 1.33 |
| Liftactiv B3 | Post Inflammatory Hyperpigmentation (PIHP) Change | 1 month | 6.56 score on a scale | Standard Deviation 1.13 |
Secondary
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).
Time frame: 1 month, 2 months, and 3 months
Population: Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Cosmeticity Questionnaire and Acceptability | 3 months | 4.39 score on a scale | Standard Deviation 0.5 |
Secondary
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).
Time frame: 1 month, 2 months, and 3 months
Population: Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Global Efficacy Assessment | 3 months | 2.56 score on a scale | Standard Error 0.68 |
Secondary
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.
Time frame: 1 month, 2 months, and 3 months
Population: Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Global Tolerance Score | 3 months | 0.11 score on a scale | Standard Deviation 0.31 |
Secondary
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.
Time frame: Baseline, 1 month, 2 months and 3 months
Population: Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Skin Condition Evaluation Scores | 3 months | 4.44 units on a scale | Standard Deviation 1.57 |
| Control Group | Change in Skin Condition Evaluation Scores | Baseline | 5.33 units on a scale | Standard Deviation 1.33 |
| Liftactiv B3 | Change in Skin Condition Evaluation Scores | 3 months | 2.67 units on a scale | Standard Deviation 1.33 |
| Liftactiv B3 | Change in Skin Condition Evaluation Scores | Baseline | 5.33 units on a scale | Standard Deviation 1.33 |
Secondary
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.
Time frame: Baseline, 1 month, 2 months and 3 months
Population: Only 12 participants completed the follow up (1 month, 2 month, and 3 month) visit assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in the Investigators Global Assessment (IGA) Scale | Baseline | 2.08 units on a scale | Standard Deviation 0.79 |
| Control Group | Change in the Investigators Global Assessment (IGA) Scale | 1 month | 1.33 units on a scale | Standard Deviation 0.5 |
| Control Group | Change in the Investigators Global Assessment (IGA) Scale | 2 months | 1.33 units on a scale | Standard Deviation 0.87 |
| Control Group | Change in the Investigators Global Assessment (IGA) Scale | 3 months | 1.33 units on a scale | Standard Deviation 0.87 |
| Liftactiv B3 | Change in the Investigators Global Assessment (IGA) Scale | 3 months | 1.44 units on a scale | Standard Deviation 0.88 |
| Liftactiv B3 | Change in the Investigators Global Assessment (IGA) Scale | Baseline | 1.92 units on a scale | Standard Deviation 0.79 |
| Liftactiv B3 | Change in the Investigators Global Assessment (IGA) Scale | 2 months | 1.33 units on a scale | Standard Deviation 0.87 |
| Liftactiv B3 | Change in the Investigators Global Assessment (IGA) Scale | 1 month | 1.22 units on a scale | Standard Deviation 0.44 |
Secondary
Exposome Questionnaire
Subjects will be questioned about environmental influences. Count of participants completing questionnaire.
Time frame: Baseline and 3 months
Population: Exposome questionnaire only consists of descriptive questions (used for data collection only), so reported here as number of participants that completed questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Exposome Questionnaire | 3 months | 9 Participants |
| Control Group | Exposome Questionnaire | Baseline | 9 Participants |