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

NCT01149876 | Completed Phase 4 Results

• 1 other identifier: 2009-P-002803
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• Change in Hyperpigmentation of the Face

  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.

  baseline to 16 weeks

Secondary Outcomes (1)

• Change in Rhytides

  baseline to week 16

Study Arms (4)

Nu Skin Product

EXPERIMENTAL

Other: Nu Skin Product

Nu Skin product with galvanic spa system

EXPERIMENTAL

Other: Nu Skin Product; Other: Cosmetic instrument

Tretinoin cream 0.05

ACTIVE COMPARATOR

Drug: Tretinoin cream 0.05

over the counter moisturizer

PLACEBO COMPARATOR

Other: CeraVe moisturizer

Interventions

Nu Skin Product OTHER

Thin layer of Nu Skin product applied to face.

Nu Skin Product; Nu Skin product with galvanic spa system

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.

Nu Skin product with galvanic spa system

Tretinoin cream 0.05 DRUG

Thin layer of tretinoin applied to face.

Tretinoin cream 0.05

CeraVe moisturizer OTHER

Thin layer of CeraVe applied to face.

over the counter moisturizer

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Scale of pigmentation didn't account for both change in color and number.

Results Point of Contact

• Title: Dr. Molly Wanner
• Organization: MGH

harvardskinstudies@partners.org

617-726-2914

Study Officials

• Molly Wanner, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician, Dermatology

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: June 24, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 6, 2014
• Results First Posted: November 6, 2014

Record last verified: 2014-10

Locations

US (1)