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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03049059
Other study ID # 087/2559
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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