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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperpigmentation

Intervention: Nu Skin Product (Other); Cosmetic instrument (Other); Tretinoin cream 0.05 (Drug); CeraVe moisturizer (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Molly Wanner, MD, Principal Investigator, Affiliation: MGH


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change in Hyperpigmentation of the Face

Secondary outcome: Change in Rhytides


Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Female.


Inclusion Criteria:

- Able to understand and sign informed consent.

- Able to complete study and comply with study procedures.

- Caucasian female ages 25-55.

- Presence of photodamage and lentigines of II-III on the Glogau Photoaging

- Must be willing to avoid laser and light treatments, treatments with filler, chemical

peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.

- Must be willing to avoid changing topical moisturizers and cosmetics during the


- Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid

derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study. Exclusion Criteria:

- Cosmetic treatment of face, such as laser or light treatment, filler, Botox,

microdermabrasion, or chemical peels 6 months prior to study or during study.

- Current smoker.

- Pregnant, nursing, or planning to become pregnant during study.

- Currently taking drugs including oral retinoids or any other medication with a known

clinically significant drug interaction with topical tretinoin.

- Known hypersensitivity to retinoids. History of severe retinoid dermatitis.

- History of substance abuse, mental dysfunction, or other factors limiting ability to

cooperate with study.

- Concurrent participation in another clinical study or participation 30 days prior to

enrollment that includes exposure to an investigational drug that would interfere with this study.

- Any disease or condition which would interfere with study participation or unduly

increase risk.

- Presence of an electrically sensitive support system such as a pacemaker.

- Known history of epilepsy.

- Presence of metal implants or metal braces on teeth.

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: June 2010
Last updated: October 30, 2014

Page last updated: August 23, 2015

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