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

NCT ID: NCT01149876

Last Updated: 2014-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperpigmentation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nu Skin Product

Group Type EXPERIMENTAL

Nu Skin Product

Intervention Type OTHER

Thin layer of Nu Skin product applied to face.

Nu Skin product with galvanic spa system

Group Type EXPERIMENTAL

Nu Skin Product

Intervention Type OTHER

Thin layer of Nu Skin product applied to face.

Cosmetic instrument

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Tretinoin cream 0.05

Intervention Type DRUG

Thin layer of tretinoin applied to face.

over the counter moisturizer

Group Type PLACEBO_COMPARATOR

CeraVe moisturizer

Intervention Type OTHER

Thin layer of CeraVe applied to face.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nu Skin Product

Thin layer of Nu Skin product applied to face.

Intervention Type 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.

Intervention Type OTHER

Tretinoin cream 0.05

Thin layer of tretinoin applied to face.

Intervention Type DRUG

CeraVe moisturizer

Thin layer of CeraVe applied to face.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Molly A. Wanner, MD

Assistant Physician, Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Molly Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-P-002803

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.