Picoseconds LaserPhase 2NCT03049059

A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

A Phase 2 study testing Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream in people with Picoseconds Laser and Melasma, run by Mae Fah Luang University Hospital.

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

A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Picoseconds Laser, Melasma
What is being tested?: Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 Jun 2016to 1 Feb 2017
Phase: Phase 2
Are there results?: None posted in the registry

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 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female with melasma lesion on bilateral sides
Age between 18-65 years
Dermal or mixed type melasma, confirming by Wood's lamp test
Willing to participant in this study and signed in informed consent form

Who cannot join

Pregnancy / lactation
Having an activity or working outside the building or unable to avoid heavy UV light
Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months
Treatment with Skin Lighting medication / food supplements within 4 weeks
Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks
Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks

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Uncontrolled medical illness include non-skin cancers, coagulopathy
Intra-cardiac device - pacemaker
Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis
Currently taking anticoagulant such as warfarin
Active skin infection or acute dermatitis at testes skin sites
Unable to follow and comply to the study protocol

About this study

A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Read the detailed description

Primary Objective:

To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives
To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

Conditions: Picoseconds Laser, Melasma
Being tested: Fractional Picosecond 1,064 nm laser, 4% hydroquinone cream
Medical subject headings: Melanosis

What participants receive

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

Fractional Picosecond 1,064 nm laserDevice
Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream
4% hydroquinone creamDrug

Study groups in NCT03049059
Study group	Role	What they receive
Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream	Experimental	Not described Receives: Device: Fractional Picosecond 1,064 nm laser; Drug: 4% hydroquinone cream
4% hydroquinone cream alone	Active comparator	Not described Receives: Drug: 4% hydroquinone cream

What is being measured

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

Modified MASI score
Measured: The mean change from the baseline to week-12 visit
Proportion of subjects with at least 50% MASI score improvement
Measured: from baseline to 12-week visit

Secondary outcomes (3)

Mexameter Melanin index
Measured: baseline, week 4, week 8 and week 12
Global satisfaction score by Quartile rating scale
Measured: week 4, week 8 and week 12
Quality of life by DLQI
Measured: at week 12

Timeline

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

1 Jun 20161 Feb 2017

First posted9 Feb 2017 (estimated)
Study start1 Jun 2016
Primary completion1 Dec 2016
Study completion1 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Picoseconds LaserStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized split face
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03049059
Sponsor's protocol ID: 087/2559
Status last verified: Feb 2017
First submitted: 3 Feb 2017
Last updated: 9 Feb 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x.
PubMed 7496671
Weiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68).

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
ClinicalTrials.gov ID: NCT03049059
Acronym / sponsor ID: 087/2559
Conditions: Picoseconds Laser, Melasma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Mae Fah Luang University HospitalUniversity, hospital or other
Study start: 1 Jun 2016 (actual)
Primary completion: 1 Dec 2016 (actual)
Study completion: 1 Feb 2017 (actual)
First posted: 9 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

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

A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Detailed description

Primary Objective:

To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives
To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Randomized split face

Arm	Type	Receives
Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream	Experimental	Device: Fractional Picosecond 1,064 nm laser, Drug: 4% hydroquinone cream
4% hydroquinone cream alone	Active comparator	Drug: 4% hydroquinone cream

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female with melasma lesion on bilateral sides
Age between 18-65 years
Dermal or mixed type melasma, confirming by Wood's lamp test
Willing to participant in this study and signed in informed consent form

Key exclusion criteria (12 listed)

Pregnancy / lactation
Having an activity or working outside the building or unable to avoid heavy UV light
Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months
Treatment with Skin Lighting medication / food supplements within 4 weeks
Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks

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
Fractional Picosecond 1,064 nm laserFractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream	Device	Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream
4% hydroquinone cream	Drug	4% hydroquinone cream alone, Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream

Primary outcome

Modified MASI score
Time frame: The mean change from the baseline to week-12 visit
Proportion of subjects with at least 50% MASI score improvement
Time frame: from baseline to 12-week visit

3 secondary outcomes

Mexameter Melanin index
Time frame: baseline, week 4, week 8 and week 12
Global satisfaction score by Quartile rating scale
Time frame: week 4, week 8 and week 12
Quality of life by DLQI
Time frame: at week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Background: PubMed 7496671Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x.
BackgroundWeiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68).
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream in people with Picoseconds Laser and Melasma, run by Mae Fah Luang University Hospital.

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 4 inclusion and 12 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Modified MASI score (time frame: The mean change from the baseline to week-12 visit). The study lists 2 primary outcomes in all. 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 NCT03049059, which also lists 2 linked publications.

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 9 Feb 2017.