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

Netherlands Institute for Pigment Disorders

Status and phase: Completed; Phase 2

Conditions: Pigmentation Disorder

Treatments: Device: Ablative fractional laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01083498

fractional-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Ablative fractional laser

Experimental group

Description:

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.

Treatment:

Device: Ablative fractional laser therapy

Control

No Intervention group

Description:

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.