Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
|ClinicalTrials.gov Identifier: NCT01149876|
Recruitment Status : Completed
First Posted : June 24, 2010
Results First Posted : November 6, 2014
Last Update Posted : November 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperpigmentation||Other: Nu Skin Product Other: Cosmetic instrument Drug: Tretinoin cream 0.05 Other: CeraVe moisturizer||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: Nu Skin Product||
Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.
|Experimental: Nu Skin product with galvanic spa system||
Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.Other: Cosmetic instrument
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
|Active Comparator: Tretinoin cream 0.05||
Drug: Tretinoin cream 0.05
Thin layer of tretinoin applied to face.
|Placebo Comparator: over the counter moisturizer||
Other: CeraVe moisturizer
Thin layer of CeraVe applied to face.
- Change in Hyperpigmentation of the Face [ Time Frame: baseline to 16 weeks ]
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.
- Change in Rhytides [ Time Frame: baseline to week 16 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149876
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Molly Wanner, MD||MGH|