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Completed

NCT Number: NCT03049059

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 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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fractional Picosecond 1,064 nm laser

Device

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

4% hydroquinone cream

Drug

Primary outcomes

  1. Modified MASI score

    Time frame: The mean change from the baseline to week-12 visit

  2. Proportion of subjects with at least 50% MASI score improvement

    Time frame: from baseline to 12-week visit

Secondary outcomes

  1. Mexameter Melanin index

    Time frame: baseline, week 4, week 8 and week 12

  2. Global satisfaction score by Quartile rating scale

    Time frame: week 4, week 8 and week 12

  3. Quality of life by DLQI

    Time frame: at week 12

Sponsors and collaborators

Lead sponsor

Mae Fah Luang University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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