Fractional Laser as Treatment Option for Various Pigment Disorders

NCT ID: NCT01083498

Last Updated: 2010-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-01-31

Brief 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.

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.

Conditions

Pigmentation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ablative fractional laser therapy

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ablative fractional laser therapy

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

Intervention Type: DEVICE

Other Intervention Names

Fraxel re:pair, Solta Medical Inc., Hayward, CA

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Netherlands Institute for Pigment Disorders

OTHER

Sponsor Role: lead

Responsible Party

Netherlands Institute for Pigment Disorders

Other Identifiers

fractional-2

Identifier Type: -

Identifier Source: org_study_id