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

Hyperpigmentation Clinical Trial

Official title:

A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149876
• Other study ID #: 2009-P-002803
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: October 30, 2014
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperpigmentation

Intervention

Other:
• Nu Skin Product
Thin layer of Nu Skin product applied to face.
• 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.

Drug:
• Tretinoin cream 0.05
Thin layer of tretinoin applied to face.

Other:
• CeraVe moisturizer
Thin layer of CeraVe applied to face.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Rhytides	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.	baseline to week 16	No