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

This study has been completed.
Information provided by (Responsible Party):
Molly A. Wanner, MD, Massachusetts General Hospital Identifier:
First received: April 30, 2010
Last updated: October 30, 2014
Last verified: October 2014
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.

Condition Intervention Phase
Hyperpigmentation Other: Nu Skin Product Other: Cosmetic instrument Drug: Tretinoin cream 0.05 Other: CeraVe moisturizer Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Molly A. Wanner, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 80
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01149876

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Molly Wanner, MD MGH
  More Information

Responsible Party: Molly A. Wanner, MD, Assistant Physician, Dermatology, Massachusetts General Hospital Identifier: NCT01149876     History of Changes
Other Study ID Numbers: 2009-P-002803
Study First Received: April 30, 2010
Results First Received: January 10, 2014
Last Updated: October 30, 2014

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents processed this record on September 21, 2017