HyperpigmentationPhase 4NCT01149876

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

A Phase 4 study testing Nu Skin Product, Cosmetic instrument and Tretinoin cream 0.05 in people with Hyperpigmentation, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hyperpigmentation
What is being tested?: Nu Skin Product, Cosmetic instrument and Tretinoin cream 0.05
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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

Conditions: Hyperpigmentation
Being tested: Nu Skin Product, Cosmetic instrument, Tretinoin cream 0.05, CeraVe moisturizer
Medical subject headings: Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nu Skin ProductOther
Thin layer of Nu Skin product applied to face.
Cosmetic instrumentOther
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
Tretinoin cream 0.05Drug
Thin layer of tretinoin applied to face.
CeraVe moisturizerOther
Thin layer of CeraVe applied to face.

Study groups in NCT01149876
Study group	Role	What they receive
Nu Skin Product	Experimental	Not described Receives: Other: Nu Skin Product
Nu Skin product with galvanic spa system	Experimental	Not described Receives: Other: Nu Skin Product; Other: Cosmetic instrument
Tretinoin cream 0.05	Active comparator	Not described Receives: Drug: Tretinoin cream 0.05
over the counter moisturizer	Placebo comparator	Not described Receives: Other: CeraVe moisturizer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline to 16 weeks

Secondary outcomes (1)

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.
Measured: baseline to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Dec 2011

First posted24 Jun 2010 (estimated)
Study startJun 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperpigmentationStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149876
Sponsor's protocol ID: 2009-P-002803
Status last verified: Oct 2014
First submitted: 30 Apr 2010
Last updated: 6 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
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Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
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All Hyperpigmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01149876
Acronym / sponsor ID: 2009-P-002803
Conditions: Hyperpigmentation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jun 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 24 Jun 2010 (estimated)
Results: Posted 6 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 25 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nu Skin ProductThin layer of Nu Skin product applied to face.	Other	Nu Skin Product, Nu Skin product with galvanic spa system
Cosmetic instrumentCosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.	Other	Nu Skin product with galvanic spa system
Tretinoin cream 0.05Thin layer of tretinoin applied to face.	Drug	Tretinoin cream 0.05
CeraVe moisturizerThin layer of CeraVe applied to face.	Other	over the counter moisturizer

Primary outcome

Change in Hyperpigmentation of the Face
Time frame: 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.

1 secondary outcome

Change in Rhytides
Time frame: baseline to week 16

Results and safety

Results posted to the registry on 6 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nu Skin Product	21	20
Over the Counter Moisturizer	20	20
Tretinoin Cream 0.05	21	20
Nu Skin Product With Galvanic Spa System	18	18

Primary outcome: Change in Hyperpigmentation of the Face

Time frame: baseline to 16 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Nu Skin Product n = 20	Over the Counter Moisturizer n = 20	Tretinoin Cream 0.05 n = 20	Nu Skin Product With Galvanic Spa System n = 18
Value	.8 (.89)	.3 (.66)	.45 (.69)	.56 (.7)

Nu Skin Product vs Over the Counter Moisturizer: p = 0.05, t-test, 2 sided
Over the Counter Moisturizer vs Tretinoin Cream 0.05: p = .25, t-test, 2 sided
Over the Counter Moisturizer vs Nu Skin Product With Galvanic Spa System: p = .48, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proprietary Topical	0 of 21 (0%)	10 of 21 (47.6%)	Not reported
Placebo	0 of 20 (0%)	13 of 20 (65%)	Not reported
Tretinoin	0 of 21 (0%)	20 of 21 (95.2%)	Not reported
Proprietary Topical Plus Iontophoresis	0 of 18 (0%)	17 of 18 (94.4%)	Not reported

Limitations and caveats (from the sponsor): Scale of pigmentation didn't account for both change in color and number.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperpigmentation

RecruitingPhase 4
Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
Telangiectasias, Reticular Veins
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Molly Wanner, MD principal investigator

MGH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nu Skin Product, Cosmetic instrument and Tretinoin cream 0.05 in people with Hyperpigmentation, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hyperpigmentation of the Face (time frame: baseline to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01149876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.