Status:
COMPLETED
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hyperpigmentation
Eligibility:
FEMALE
25-55 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01149876
Start Date
June 1 2010
End Date
December 1 2011
Last Update
November 6 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114