NCT03049059

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 3, 2017

Last Update Submit

February 7, 2017

Conditions

Picoseconds LaserMelasma

Outcome Measures

Primary Outcomes (2)

  • Modified MASI score

    The mean change from the baseline to week-12 visit

  • Proportion of subjects with at least 50% MASI score improvement

    from baseline to 12-week visit

Secondary Outcomes (3)

  • Mexameter Melanin index

    baseline, week 4, week 8 and week 12

  • Global satisfaction score by Quartile rating scale

    week 4, week 8 and week 12

  • Quality of life by DLQI

    at week 12

Study Arms (2)

Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream

EXPERIMENTAL
Device: Fractional Picosecond 1,064 nm laserDrug: 4% hydroquinone cream

4% hydroquinone cream alone

ACTIVE COMPARATOR
Drug: 4% hydroquinone cream

Interventions

Fractional Picosecond 1,064 nm laserDEVICE

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

Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream
4% hydroquinone creamDRUG
4% hydroquinone cream aloneFractional Picosecond 1,064 nm laser and 4% hydroquinone cream

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 7496671BACKGROUND

  • 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).

    BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized split face
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 9, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share