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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Hyperpigmentation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01149876

2009-P-002803

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

Nu Skin Product

Experimental group

Treatment:

Other: Nu Skin Product

Nu Skin product with galvanic spa system

Experimental group

Treatment:

Other: Cosmetic instrument

Other: Nu Skin Product

Tretinoin cream 0.05

Active Comparator group

Treatment:

Drug: Tretinoin cream 0.05

over the counter moisturizer

Placebo Comparator group

Treatment:

Other: CeraVe moisturizer