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

Phase 4

Completed

Interventions: Other: Nu Skin Product
Drug: Tretinoin cream 0.05
Other: CeraVe moisturizer
Other: Cosmetic instrument

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Nu Skin Product	Nu Skin Product	-
Nu Skin product with galvanic spa system	Nu Skin Product	-
Tretinoin cream 0.05	Tretinoin cream 0.05	-
Nu Skin product with galvanic spa system	Cosmetic instrument	-
over the counter moisturizer	CeraVe moisturizer	-

Primary Outcome Measures

Name	Time	Method
Change in Hyperpigmentation of the Face	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

Name	Time	Method
Change in Rhytides	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.