Fractional Laser as Treatment Option for Various Pigment Disorders (fractional-2)

Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study

The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.

Study Overview

• Status: Completed
• Conditions: Pigmentation Disorder
• Intervention / Treatment: Device: Ablative fractional laser therapy

Detailed Description

Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Becker nevus
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablative fractional laser; In each patient, a square test region of 5-10 cm2 was treated with ablative fractional laser in three sessions in combination with intermittent topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream) to prevent laser-induced postinflammatory hyperpigmentation. Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.	Device: Ablative fractional laser therapy; 10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3; Other Names: Fraxel re:pair, Solta Medical Inc., Hayward, CA
No Intervention: Control; In each patient, a square test region of 5-10 cm2 was treated with topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream)alone (to allow comparison of the regions). Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, reflecting the lightness of the measured area of skin, was used.	T0, 3 and six months follow-up
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 and 6 months follow-up
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 and 6 months follow-up
Patient's satisfaction	Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.	3 and 6 months follow-up
Histopathologic assessment	In order to evaluate for microscopic and ultrastructural treatment induced changes, 2 mm punch biopsies were taken from all patients at three months follow-up. Biopsies were taken from the optical centre of both treated and control site. All biopsy specimens were split for processing for light microscopy. .... was assessed by an independent blinded pathologist.	3 months follow-up

Collaborators and Investigators

• Sponsor: Netherlands Institute for Pigment Disorders

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 9, 2010

Study Record Updates

• Last Update Posted (Estimate): March 9, 2010
• Last Update Submitted That Met QC Criteria: March 8, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: randomized controlled trial; Becker's nevus; ablative fractional laser therapy; split-lesion design
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: fractional-2