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The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nu Skin Product | Experimental |
| |
| Nu Skin product with galvanic spa system | Experimental |
| |
| Tretinoin cream 0.05 | Active Comparator |
| |
| over the counter moisturizer | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nu Skin Product | Other | Thin layer of Nu Skin product applied to face. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hyperpigmentation of the Face | Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16. Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation. | baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rhytides | Secondary outcome measures will be change in rhytides of baseline compared to week 16. Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines. | baseline to week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly Wanner, MD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Wash out period to allow subjects to d/c any topicals that would interfere with study or met exclusion criteria.
Recruitment period 2010-2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nu Skin Product | |
| FG001 | Over the Counter Moisturizer | CeraVe Moisturizer |
| FG002 | Tretinoin Cream 0.05 | |
| FG003 | Nu Skin Product With Galvanic Spa System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proprietary Topical | |
| BG001 | Placebo | |
| BG002 | Tretinoin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Hyperpigmentation of the Face | Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16. Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation. | Posted | Mean | Standard Deviation | units on a scale | baseline to 16 weeks |
|
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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 | Proprietary Topical |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental Abscess | Skin and subcutaneous tissue disorders |
Scale of pigmentation didn't account for both change in color and number.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Molly Wanner | MGH | 617-726-2914 | harvardskinstudies@partners.org |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Cosmetic instrument | Other | Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes. |
|
| Tretinoin cream 0.05 | Drug | Thin layer of tretinoin applied to face. |
|
| CeraVe moisturizer | Other | Thin layer of CeraVe applied to face. |
|
| BG003 | Proprietary Topical Plus Iontophoresis |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Hyperpigmentation Score | Mean | Standard Deviation | units on a scale |
|
| OG003 |
| Nu Skin Product With Galvanic Spa System |
|
|
|
| Secondary | Change in Rhytides | Secondary outcome measures will be change in rhytides of baseline compared to week 16. Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines. | Posted | Mean | Standard Deviation | units on a scale | baseline to week 16 |
|
|
|
| 0 |
| 21 |
| 10 |
| 21 |
| EG001 | Placebo | 0 | 20 | 13 | 20 |
| EG002 | Tretinoin | 0 | 21 | 20 | 21 |
| EG003 | Proprietary Topical Plus Iontophoresis | 0 | 18 | 17 | 18 |
| Depression | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| GI upset | Gastrointestinal disorders |
|
| Low Vit D | Metabolism and nutrition disorders |
|
| Acne | Skin and subcutaneous tissue disorders |
|
| Tennis elbow | Musculoskeletal and connective tissue disorders |
|
| Peeling skin | Skin and subcutaneous tissue disorders |
|
| Metal taste | Skin and subcutaneous tissue disorders |
|
| Redness | Skin and subcutaneous tissue disorders |
|
| Dryness | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Wrist injury | Musculoskeletal and connective tissue disorders |
|
| HSV | Skin and subcutaneous tissue disorders |
|
| Mild shock | Skin and subcutaneous tissue disorders |
|
| Increased sneezing | Respiratory, thoracic and mediastinal disorders |
|
| Fall | Musculoskeletal and connective tissue disorders |
|
| Pinched nerve | Nervous system disorders |
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| Tendonitis | Musculoskeletal and connective tissue disorders |
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| Irritant dermatitis | Skin and subcutaneous tissue disorders |
|
| Rosacea | Skin and subcutaneous tissue disorders |
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| Burning | Skin and subcutaneous tissue disorders |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders |
|
| URI | Respiratory, thoracic and mediastinal disorders |
|
| VZV | Skin and subcutaneous tissue disorders |
|
| Pain with eating | Gastrointestinal disorders |
|
| Flaking of skin | Skin and subcutaneous tissue disorders |
|
| Angiofibroma | Skin and subcutaneous tissue disorders |
|
| Dental filling | Skin and subcutaneous tissue disorders |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders |
|
| Kidney stone | Renal and urinary disorders |
|
| Milia | Skin and subcutaneous tissue disorders |
|
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