NCT01085279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

11 months

First QC Date

March 10, 2010

Last Update Submit

March 10, 2010

Conditions

Pigmentation Disorder

Keywords

fractional lasermelasmatopical bleaching

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 weeks, and 3 and 6 months follow-up

Secondary Outcomes (4)

  • L-value

    T0, 3 weeks and 3 and 6 months follow-up

  • Melanin index

    T0, 3 weeks and 3, and 6 months follow-up

  • Patient's global assessment

    3 weeks, 3 and 6 months follow-up

  • Patient's satisfaction

    3 weeks, 3 and 6 months follow-up

Study Arms (2)

Non-ablative fractional laser

EXPERIMENTAL

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.

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

Triple topical therapy

ACTIVE COMPARATOR

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.

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

Interventions

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

1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5

Also known as: Fraxel re:store, Solta Medical Inc., Hayward, CA
Non-ablative fractional laser
Modified Kligman's formula (Triple topical therapy)DRUG

Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks

Also known as: modified Kligman formula
Triple topical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Pigment disorders

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Pigmentation DisordersMelanosis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperpigmentation

Study Officials

  • Albert Wolkerstorfer, MD PhD

    Netherlands Institute for Pigment Disorders

    PRINCIPAL INVESTIGATOR

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 10, 2010

First Posted

March 11, 2010

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

NL(1)