Clinical Trial: Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: 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.



Original Primary Outcome: Change in Hyperpigmentation of the Face [ Time Frame: 16 weeks ]

Current Secondary Outcome: 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.



Original Secondary Outcome: change in rhytides and roughness [ Time Frame: week 16 ]

Information By: Massachusetts General Hospital

Dates:
Date Received: April 30, 2010
Date Started: June 2010
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014