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

Melasma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049059
• Other study ID #: 087/2559
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2017
• Last updated: February 7, 2017
• Start date: June 1, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2017
• Source: Mae Fah Luang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma
• Picoseconds Laser

Intervention

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

Drug:
• 4% hydroquinone cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mae Fah Luang University Hospital

References & 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. — View 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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified MASI score		The mean change from the baseline to week-12 visit
Primary	Proportion of subjects with at least 50% MASI score improvement		from baseline to 12-week visit
Secondary	Mexameter Melanin index		baseline, week 4, week 8 and week 12
Secondary	Global satisfaction score by Quartile rating scale		week 4, week 8 and week 12
Secondary	Quality of life by DLQI		at week 12