Fractional Laser as Treatment Option for Various Pigment Disorders - Full Text View

Sponsor:	Netherlands Institute for Pigment Disorders
Information provided by:	Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier:	NCT01083498

Purpose

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

Condition	Intervention	Phase
Pigmentation Disorder	Device: Ablative fractional laser therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Moles Skin Pigmentation Disorders

U.S. FDA Resources

Further study details as provided by Netherlands Institute for Pigment Disorders:

Primary Outcome Measures:

Physician's global assessment [ Time Frame: T0, 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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).

Secondary Outcome Measures:

L-value [ Time Frame: T0, 3 and six months follow-up ] [ Designated as safety issue: Yes ]
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.
Melanin index [ Time Frame: T0, 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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.
Patient's global assessment [ Time Frame: 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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.
Patient's satisfaction [ Time Frame: 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
Histopathologic assessment [ Time Frame: 3 months follow-up ] [ Designated as safety issue: No ]
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.

Enrollment:	11
Study Start Date:	March 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.

Arms

Assigned Interventions

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 Name: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	A Wolkerstorfer, MD PhD, Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier:	NCT01083498 History of Changes
Other Study ID Numbers:	fractional-2
Study First Received:	March 8, 2010
Last Updated:	March 8, 2010
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Netherlands Institute for Pigment Disorders:

Becker's nevus
ablative fractional laser therapy
randomized controlled trial
split-lesion design

Additional relevant MeSH terms:

Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 24, 2012