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

NCT ID: NCT03049059

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-02-01

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

Conditions

Picoseconds Laser; Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Fractional Picosecond 1,064 nm laser

Intervention Type: DEVICE

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

4% hydroquinone cream

Intervention Type: DRUG

4% hydroquinone cream alone

Group Type: ACTIVE_COMPARATOR

4% hydroquinone cream

Intervention Type: DRUG

Interventions

Fractional Picosecond 1,064 nm laser

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

Intervention Type: DEVICE

4% hydroquinone cream

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mae Fah Luang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thep Chalermchai

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 7496671 (View on PubMed)

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).

Reference Type: BACKGROUND

Other Identifiers

087/2559

Identifier Type: -

Identifier Source: org_study_id