Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)

Pigmentation Disorder Clinical Trial

Official title:

Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085279
• Other study ID #: fractional-3
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2010
• Last updated: March 10, 2010
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Netherlands Institute for Pigment Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Melasma

• Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders

• Age at least 18 years

• Subject is willing and able to give written informed consent

Exclusion Criteria:

• use of bleaching creams during the past six weeks

• history of keloid

• active eczema

• suspected hypersensitivity to lidocaine or triple therapy

• use of isotretinoin in the past six months

• high exposure of the lesion to sunlight or UV light (UVA or UVB).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pigmentation Disorder
• Pigmentation Disorders

Intervention

Device:
• Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)
1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5

Drug:
• Modified Kligman's formula (Triple topical therapy)
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks

Locations

Country	Name	City	State
Netherlands	Netherlands Institute for Pigment disorders	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Netherlands Institute for Pigment Disorders

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's global assessment	Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).	T0, 3 weeks, and 3 and 6 months follow-up	Yes
Secondary	L-value	Improvement of hyperpigmentation was assessed by color measurement through reflectance spectroscopy (Microflash 200 d, Datacolor International, Lawrenceville, GA). This instrument, with an aperture of 4 mm, determines color by measuring the intensity of reflected light of particular wavelengths. In this study, the obtained L value, indicating the lightness of the measured area of skin, was used.	T0, 3 weeks and 3 and 6 months follow-up	Yes
Secondary	Melanin index	Melanin index was measured using a spectrometer (Derma-Spectrometer, Cortex Technology ApS, Hadsund, Denmark) in order to assess changes in the amount of dermal and epidermal melanin.	T0, 3 weeks and 3, and 6 months follow-up	Yes
Secondary	Patient's global assessment	Patients were asked to score the improvement of hyperpigmentation on a visual analogue scale (VAS) from 0 to 10 (Patient's Global Assessment, PGA) at all follow-up moments.	3 weeks, 3 and 6 months follow-up	Yes
Secondary	Patient's satisfaction	Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.	3 weeks, 3 and 6 months follow-up	Yes