Fractional Laser as Treatment Option for Various Pigment Disorders

Pigmentation Disorder Clinical Trial

— fractional-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083498
• Other study ID #: fractional-2
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: March 8, 2010
• Start date: March 2009
• Est. completion date: January 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 ablative fractional laser is effective in the treatment of Becker's nevus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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:
• Ablative fractional laser therapy
10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Netherlands Institute for Pigment Disorders

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 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, reflecting the lightness of the measured area of skin, was used.	T0, 3 and six 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 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 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 and 6 months follow-up	Yes
Secondary	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	No