Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Picoseconds Laser
Melasma
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized split face
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Modified MASI score
timeFrame: The mean change from the baseline to week-12 visit
measure: Proportion of subjects with at least 50% MASI score improvement
timeFrame: from baseline to 12-week visit
Secondary outcomes:
measure: Mexameter Melanin index
timeFrame: baseline, week 4, week 8 and week 12
measure: Global satisfaction score by Quartile rating scale
timeFrame: week 4, week 8 and week 12
measure: Quality of life by DLQI
timeFrame: at week 12
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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).