Fractional Laser as Treatment Option for Various Pigment Disorders

NCT01083498 | Completed Phase 2

• 1 other identifier: fractional-2
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pigmentation Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• L-value

  T0, 3 and six months follow-up

• Melanin index

  T0, 3 and 6 months follow-up

• Patient's global assessment

  3 and 6 months follow-up

• Patient's satisfaction

  3 and 6 months follow-up

• Histopathologic assessment

  3 months follow-up

Study Arms (2)

Ablative fractional laser

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Ablative fractional laser therapy DEVICE

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

Also known as: Fraxel re:pair, Solta Medical Inc., Hayward, CA

Ablative fractional laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Netherlands Institute for Pigment Disorders: lead

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 9, 2010

Record last verified: 2010-03