Hyperpigmentation
Conditions
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.
Interventions
OTHERNu Skin Product
Thin layer of Nu Skin product applied to face.
OTHERCosmetic instrument
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
DRUGTretinoin cream 0.05
Thin layer of tretinoin applied to face.
OTHERCeraVe moisturizer
Thin layer of CeraVe applied to face.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hyperpigmentation of the Face | baseline to 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rhytides | baseline to week 16 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period 2010-2011.
Pre-assignment details
Wash out period to allow subjects to d/c any topicals that would interfere with study or met exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Proprietary Topical | 21 |
| Placebo | 20 |
| Tretinoin | 21 |
| Proprietary Topical Plus Iontophoresis | 18 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | Tretinoin | Placebo | Proprietary Topical | Proprietary Topical Plus Iontophoresis |
|---|---|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 7.6 | 42.3 years STANDARD_DEVIATION 8.7 | 46.9 years STANDARD_DEVIATION 8.3 | 47.4 years STANDARD_DEVIATION 6.3 | 49.6 years STANDARD_DEVIATION 5.5 |
| Baseline Hyperpigmentation Score | 3.4 units on a scale STANDARD_DEVIATION 1 | 3.3 units on a scale STANDARD_DEVIATION 1.17 | 3.35 units on a scale STANDARD_DEVIATION 0.93 | 3.7 units on a scale STANDARD_DEVIATION 1.03 | 3.28 units on a scale STANDARD_DEVIATION 1.07 |
| Region of Enrollment United States | 80 participants | 21 participants | 20 participants | 21 participants | 18 participants |
| Sex: Female, Male Female | 80 Participants | 21 Participants | 20 Participants | 21 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 21 | 13 / 20 | 20 / 21 | 17 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 21 | 0 / 18 |
Outcome results
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.
Time frame: baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nu Skin Product | Change in Hyperpigmentation of the Face | .8 units on a scale | Standard Deviation 0.89 |
| Over the Counter Moisturizer | Change in Hyperpigmentation of the Face | .3 units on a scale | Standard Deviation 0.66 |
| Tretinoin Cream 0.05 | Change in Hyperpigmentation of the Face | .45 units on a scale | Standard Deviation 0.69 |
| Nu Skin Product With Galvanic Spa System | Change in Hyperpigmentation of the Face | .56 units on a scale | Standard Deviation 0.7 |
p-value: 0.05t-test, 2 sided
p-value: 0.25t-test, 2 sided
p-value: 0.48t-test, 2 sided
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.
Time frame: baseline to week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nu Skin Product | Change in Rhytides | .25 units on a scale | Standard Deviation 0.91 |
| Over the Counter Moisturizer | Change in Rhytides | .4 units on a scale | Standard Deviation 0.75 |
| Tretinoin Cream 0.05 | Change in Rhytides | -.05 units on a scale | Standard Deviation 0.69 |
| Nu Skin Product With Galvanic Spa System | Change in Rhytides | .47 units on a scale | Standard Deviation 0.51 |