Condition category
Skin and Connective Tissue Diseases
Date applied
13/07/2007
Date assigned
04/03/2008
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Albert Wolkerstorfer

ORCID ID

Contact details

Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 6955
a.wolkerstorfer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

fraxel-1

Study information

Scientific title

Acronym

Study hypothesis

Fractional photothermolysis may be an effective and safe alternative for the treatment of melasma and the effect of the treatment with fractional photothermolysis may last longer than the effect of the triple therapy.

Ethics approval

Ethics approval received from the Centrale Commissie Mensgebonden Onderzoek (CCMO) on the 19th September 2007 (ref: NL18605.018.07).

Study design

Randomised, controlled, parallel group, observer blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Melasma

Intervention

Subjects will be randomly allocated to one of two groups who receive either triple therapy (bleaching cream [hydrochinon 5%, tretinoin 0.05% and triamcinolon acetonide 0.1% in cremor lanette II]) or fractional photothermilysis using the fraxel laser.

Triple therapy:
The triple therapy will be applied once a day in the evening on all hyperpigmented macules for eight weeks. Follow-up will take 3, 12 and 24 weeks post therapy.

Fractional photothermolysis:
Subject will receive a total of four laser treatments, with two week intervals. A topical anaesthetic ointment will be applied to the skin before treatment. The treated area will be less than 3% of the body surface. Follow-up will take place 3, 12 and 24 weeks post therapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Triple therapy bleaching cream (hydrochinon, tretinoin, triamcinolon acetonide)

Primary outcome measures

1. Observer blinded clinical score (Melasma Area and Severity Index [MASI] score), measured before treatment and during 3, 12 and 24 weeks of follow-up
2. Objective colour measurement by reflectance spectroscopy, measured before treatment and during 3, 12 and 24 weeks of follow-up

Secondary outcome measures

1. Visual assessment of side effects and quality of life measurements (skindex):
1.1. Fraxel laser group: after laser treatment and during follow-up (3, 12, 24 weeks)
1.2. Triple group: during follow-up (3, 12, 24 weeks)
2. Registration of side effects noticed by the patient:
2.1. Fraxel group: after laser treatment and during follow-up
2.2. Triple group: after three weeks of treatment by telephone

Overall trial start date

20/09/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients with melasma
2. Skin photo type II - V
3. Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
4. Aged at least 18 years
5. Subject is willing and able to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Bleaching cream during the past four weeks
2. Local corticosteroids during the past four weeks
3. Subjects with a history of keloids
4. Subjects with active eczema
5. Subjects with active acne in the face
6. Subjects with a history of facial eczema
7. Suspect allergy to lidocaine or the triple therapy
8. Use of roaccutane in the past six months
9. Subjects not competent to understand what is involved
10. Pregnancy
11. Lesion suspicious for malignancy
12. High exposure to sunlight (vacation in southern countries) or ultraviolet (UV) light (UVA or UVB)

Recruitment start date

20/09/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 35
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 6955
a.wolkerstorfer@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes