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Subjects will be assigned to a active cream or vehicle to compare the cosmetic effects. This will take place over a 12 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Synergistic combination of Bakuchiol and Ethyl Linoleate |
|
| Vehicle | Placebo Comparator | No active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bakuchiol and Ethyl Linoleate | Other | A synergistic combination of Bakuchiol and Ethyl Linoleate |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGA Score | IGA score of zero (clear) or one (almost clear) | From baseline to week 12 |
| Facial lesions | Percent reductions in facial lesion counts for inflammatory and noninflammatory | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Total lesion count | Percent change in Global Face Total Lesion Count | From baseline to week 2 |
| Total lesion count | Percent change in Global Face Total Lesion Count |
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Inclusion Criteria:
Females of child-bearing potential (FCBP): A female is considered not to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea or has undergone surgical sterilization. While on the study, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jack Donnelly | Contact | 44(0)1617911797 | jack@princetonconsumer.com | |
| Terrie Bennett | Contact | 44(0)1245 934050 | Terrie@princetonconsumer.com |
| Name | Affiliation | Role |
|---|---|---|
| Barrie Drewitt | Princeton Consumer Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Consumer Research Corp | Recruiting | Chelmsford | England | CM2 6UA | United Kingdom |
No plan on sharing IPD to other researchers
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C012765 | bakuchiol |
| C007678 | ethyl linoleate |
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| Vehicle | Other | No actives |
|
| From baseline to week 4 |
| Total lesion count | Percent change in Global Face Total Lesion Count | From baseline to week 8 |
| Total lesion count | Percent change in Global Face Total Lesion Count | From baseline to week 12 |
| IGA score | IGA score of zero (clear) or one (almost clear) as compared to vehicle | From baseline to week 2, 4, 8, 12 |
| IGA score | IGA score of zero (clear) or one (almost clear) | From baseline to week 4 |
| IGA score | IGA score of zero (clear) or one (almost clear) | From baseline to week 8 |
| IGA score | IGA score of zero (clear) or one (almost clear) | From baseline to week 12 |
| IGA score | IGA score of zero (clear) or one (almost clear) as compared to vehicle | From baseline to week 2, 4, 8 & 12 |
| Inflammatory and non-inflammatory leisons | Percent reductions in facial lesion counts for inflammatory and noninflammatory | From baseline to week 2 |
| Inflammatory and non-inflammatory leisons | Percent reductions in facial lesion counts for inflammatory and noninflammatory | From baseline to week 4 |
| Inflammatory and non-inflammatory leisons | Percent reductions in facial lesion counts for inflammatory and noninflammatory | From baseline to week 8 |
| Inflammatory and non-inflammatory leisons | Percent reductions in facial lesion counts for inflammatory and noninflammatory | From baseline to week 12 |
| Inflammatory and non-inflammatory leisons | Percent reductions in facial lesion counts for inflammatory and noninflammatory as compared to vehicle | From baseline to week 2, 4, 8 & 12 |
| Post inflammatory hyperpigmentation | Percent reduction in overall post inflammatory hyperpigmentation | From baseline to week 2 |
| Post inflammatory hyperpigmentation | Percent reduction in overall post inflammatory hyperpigmentation | From baseline to week 4 |
| Post inflammatory hyperpigmentation | Percent reduction in overall post inflammatory hyperpigmentation | From baseline to week 8 |
| Post inflammatory hyperpigmentation | Percent reduction in overall post inflammatory hyperpigmentation | From baseline to week 12 |
| Post inflammatory hyperpigmentation | Percent reduction in overall post inflammatory hyperpigmentation as compared to vehicle | From baseline to week 2, 4, 8 & 12 |