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| Name | Class |
|---|---|
| Burt's Bees Inc. | INDUSTRY |
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The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balancing gel cream | Experimental | Product will be used twice daily in the morning and in the evening for 6 weeks. 1-2 pumps (dime size) of product will be applied on the face. In addition to the study product, a Cetaphil cleanser will be used as well. Cleanser will be applied twice daily in the morning and in the evening for 6 weeks. Cleanser will be used on wet face and gently pat dry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balancing gel cream | Other | Skin balancing gel cream will be applied onto clean skin morning and night |
|
| Measure | Description | Time Frame |
|---|---|---|
| C. acnes relative abundance | Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional gene based predictive analysis of skin inflammation related genes | Functional gene analysis for skin inflammation related genes from whole genome sequencing of facial skin microbiome | 6 weeks |
| Sebum excretion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nhi Nguyen | Contact | 916-750-2463 | research@integrativeskinresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, MD MS AP | Integrative Skin Science and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin and Research | Recruiting | Sacramento | California | 95815 | United States |
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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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Measure of skin sebum via sebumeter
| 6 weeks |
| Tolerability Assessment Questionnaire | A 6 question survey based on the self-assessment about the tolerability of the topical skin product such as itching, burning, and stinging. The scale ranges from 0-3 with 0 being the best outcome possible and with 3 being the worst. "0" as none, "1" as mild, "2" as moderate, or "3" as severe. | 6 weeks |
| Total lesion count | Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne | 6 weeks |