Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)

Netherlands Institute for Pigment Disorders

Status and phase: Completed; Phase 2

Conditions: Pigmentation Disorder

Treatments: Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser); Drug: Modified Kligman's formula (Triple topical therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT01085279

fractional-3

Details and patient eligibility

About

The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Melasma
• 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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29 participants in 2 patient groups

Non-ablative fractional laser

Experimental group

Description:

In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

Treatment:

Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)

Triple topical therapy

Active Comparator group

Description:

In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

Treatment:

Drug: Modified Kligman's formula (Triple topical therapy)