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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation
• Intervention / Treatment: Other: Nu Skin Product; Other: Cosmetic instrument; Drug: Tretinoin cream 0.05; Other: CeraVe moisturizer

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Molly Wanner, MD, MGH

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 24, 2010

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: 2009-P-002803