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OpenTrials
Completed

NCT Number: NCT01149876

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nu Skin Product

Other

Thin layer of Nu Skin product applied to face.

Cosmetic instrument

Other

Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.

Tretinoin cream 0.05

Drug

Thin layer of tretinoin applied to face.

CeraVe moisturizer

Other

Thin layer of CeraVe applied to face.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 24, 2010
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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