Trial Outcomes & Findings for Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots (NCT NCT01149876)
NCT ID: NCT01149876
Last Updated: 2014-11-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
baseline to 16 weeks
Results posted on
2014-11-06
Participant Flow
Recruitment period 2010-2011.
Wash out period to allow subjects to d/c any topicals that would interfere with study or met exclusion criteria.
Participant milestones
| Measure |
Nu Skin Product
|
Over the Counter Moisturizer
CeraVe Moisturizer
|
Tretinoin Cream 0.05
|
Nu Skin Product With Galvanic Spa System
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
18
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
Baseline characteristics by cohort
| Measure |
Proprietary Topical
n=21 Participants
|
Placebo
n=20 Participants
|
Tretinoin
n=21 Participants
|
Proprietary Topical Plus Iontophoresis
n=18 Participants
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
46.9 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
49.6 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 7.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
21 participants
n=206 Participants
|
18 participants
n=7 Participants
|
80 participants
n=31 Participants
|
|
Baseline Hyperpigmentation Score
|
3.7 units on a scale
STANDARD_DEVIATION 1.03 • n=99 Participants
|
3.35 units on a scale
STANDARD_DEVIATION .93 • n=107 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 1.17 • n=206 Participants
|
3.28 units on a scale
STANDARD_DEVIATION 1.07 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1 • n=31 Participants
|
PRIMARY outcome
Timeframe: baseline to 16 weeksPrimary 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.
Outcome measures
| Measure |
Nu Skin Product
n=20 Participants
|
Over the Counter Moisturizer
n=20 Participants
CeraVe cream
|
Tretinoin Cream 0.05
n=20 Participants
|
Nu Skin Product With Galvanic Spa System
n=18 Participants
|
|---|---|---|---|---|
|
Change in Hyperpigmentation of the Face
|
.8 units on a scale
Standard Deviation .89
|
.3 units on a scale
Standard Deviation .66
|
.45 units on a scale
Standard Deviation .69
|
.56 units on a scale
Standard Deviation .7
|
SECONDARY outcome
Timeframe: baseline to week 16Secondary 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.
Outcome measures
| Measure |
Nu Skin Product
n=20 Participants
|
Over the Counter Moisturizer
n=20 Participants
CeraVe cream
|
Tretinoin Cream 0.05
n=20 Participants
|
Nu Skin Product With Galvanic Spa System
n=18 Participants
|
|---|---|---|---|---|
|
Change in Rhytides
|
.25 units on a scale
Standard Deviation .91
|
.4 units on a scale
Standard Deviation .75
|
-.05 units on a scale
Standard Deviation .69
|
.47 units on a scale
Standard Deviation .51
|
Adverse Events
Proprietary Topical
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Tretinoin
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Proprietary Topical Plus Iontophoresis
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proprietary Topical
n=21 participants at risk
|
Placebo
n=20 participants at risk
|
Tretinoin
n=21 participants at risk
|
Proprietary Topical Plus Iontophoresis
n=18 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dental Abscess
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Gastrointestinal disorders
GI upset
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Low Vit D
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Acne
|
19.0%
4/21 • Number of events 4
|
35.0%
7/20 • Number of events 7
|
14.3%
3/21 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Tennis elbow
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Peeling skin
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Metal taste
|
0.00%
0/21
|
0.00%
0/20
|
9.5%
2/21 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Redness
|
0.00%
0/21
|
0.00%
0/20
|
19.0%
4/21 • Number of events 4
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dryness
|
0.00%
0/21
|
0.00%
0/20
|
9.5%
2/21 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Wrist injury
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HSV
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
16.7%
3/18 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Mild shock
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Increased sneezing
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Pinched nerve
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/21
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Irritant dermatitis
|
0.00%
0/21
|
0.00%
0/20
|
9.5%
2/21 • Number of events 2
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Burning
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/21
|
0.00%
0/20
|
9.5%
2/21 • Number of events 2
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
VZV
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Pain with eating
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Flaking of skin
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Angiofibroma
|
0.00%
0/21
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Dental filling
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
0.00%
0/18
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/21
|
10.0%
2/20 • Number of events 2
|
0.00%
0/21
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place