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
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.
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
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
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
study.
- 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
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