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| Name | Class |
|---|---|
| Dermatology Consulting Services, High Point NC | OTHER |
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This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nature-Based Sensitive Skin Regimen | Experimental | Burt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR):
|
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| Control Regimen | Active Comparator | Control Skin Care Regimen (Control Regimen, CR):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burt's Bees Skin Care Regimen | Other | Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment of Rosacea Scale Score | The primary efficacy endpoint is no increase in the cumulative Investigator Global Assessment of Rosacea Scale score, measured at Week 4 from baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Skin Quality | The secondary efficacy endpoint is at least no increase in the Overall Skin Quality domain of the Subject-Rated Efficacy Scale score, measured at Week 4 from baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss | No increase in transepidermal water loss values measured at Week 4 from baseline | 4 weeks |
| Corneometry | No decrease in corneometry values at Week 4 from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe D Draelos, MD | Dermatology Consulting Services, High Point NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30794364 | Derived | Draelos ZD, Gunt H, Levy SB. Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea. J Drugs Dermatol. 2019 Feb 1;18(2):141-146. |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Control Regimen | Other | Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily) |
|
| 4 weeks |