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

Primary Purpose

Hyperpigmentation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nu Skin Product
Cosmetic instrument
Tretinoin cream 0.05
CeraVe moisturizer
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperpigmentation

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nu Skin Product

Nu Skin product with galvanic spa system

Tretinoin cream 0.05

over the counter moisturizer

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 30, 2010
Last Updated
October 30, 2014
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01149876
Brief Title
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nu Skin Product
Arm Type
Experimental
Arm Title
Nu Skin product with galvanic spa system
Arm Type
Experimental
Arm Title
Tretinoin cream 0.05
Arm Type
Active Comparator
Arm Title
over the counter moisturizer
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Nu Skin Product
Intervention Description
Thin layer of Nu Skin product applied to face.
Intervention Type
Other
Intervention Name(s)
Cosmetic instrument
Intervention Description
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
Intervention Type
Drug
Intervention Name(s)
Tretinoin cream 0.05
Intervention Description
Thin layer of tretinoin applied to face.
Intervention Type
Other
Intervention Name(s)
CeraVe moisturizer
Intervention Description
Thin layer of CeraVe applied to face.
Primary Outcome Measure Information:
Title
Change in Hyperpigmentation of the Face
Description
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.
Time Frame
baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Change in Rhytides
Description
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.
Time Frame
baseline to week 16

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Wanner, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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