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Enrollment timeline ended
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| Name | Class |
|---|---|
| Vichy Laboratoires | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liftactiv B3 | Drug | Participants will apply a dime size amount of the serum to 1 side of the face. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 2 months and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 2 months and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33125 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only 9 participants completed the the follow up (1 month, 2 month, and 3 month) visit assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 2 months and 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enzo Berardesca | University of Miami | 3052434472 | exb743@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2022 | Jan 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D013473 | Sunscreening Agents |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Sunscreen | Other | Participants will apply a dime size amount of sunscreen to cover the other half of the face. |
|
| 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. |
| 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). | 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. | 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). | 1 month, 2 months, and 3 months |
| Exposome Questionnaire | Subjects will be questioned about environmental influences. Count of participants completing questionnaire. | Baseline and 3 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Liftactiv B3 |
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. |
|
|
| 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. | Only 12 participants completed the follow up (1 month, 2 month, and 3 month) visit assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months and 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months and 3 months |
|
|
|
| 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). | 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. | Posted | Mean | Standard Error | score on a scale | 1 month, 2 months, and 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 2 months, and 3 months |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 2 months, and 3 months |
|
|
|
| Secondary | Exposome Questionnaire | Subjects will be questioned about environmental influences. Count of participants completing questionnaire. | Exposome questionnaire only consists of descriptive questions (used for data collection only), so reported here as number of participants that completed questionnaire. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Liftactiv B3 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D010859 | Pigmentation Disorders |
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| 2 months |
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| 3 months |
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| 2 months |
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| 1 months |
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| Baseline |
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| 1 month |
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| 1 month |
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| 1 month |
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