Phase 4
N=80
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
Hyperpigmentation
Bottom Line
View on ClinicalTrials.gov: NCT01149876 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Change in Hyperpigmentation of the Face — .8; .3; .45; .56 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nu Skin Product (Other); Cosmetic instrument (Other); Tretinoin cream 0.05 (Drug); CeraVe moisturizer (Other)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hyperpigmentation of the Face |
.8; .3; .45; .56 | 0.05 |
| SECONDARY Change in Rhytides |
.25; .4; -.05; .47 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01149876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.