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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01149876
Recruitment Status : Completed
First Posted : June 24, 2010
Results First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):
Molly A. Wanner, MD, Massachusetts General Hospital

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tretinoin

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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01149876

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Molly Wanner, MD MGH
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Responsible Party: Molly A. Wanner, MD, Assistant Physician, Dermatology, Massachusetts General Hospital Identifier: NCT01149876    
Other Study ID Numbers: 2009-P-002803
First Posted: June 24, 2010    Key Record Dates
Results First Posted: November 6, 2014
Last Update Posted: November 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents