Fractional photothermolysis versus triple therapy for the treatment of melasma: a randomised controlled trial

ISRCTN	ISRCTN84133969
DOI	https://doi.org/10.1186/ISRCTN84133969
Protocol serial number	fraxel-1
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

Submission date: 13/07/2007
Registration date: 04/03/2008
Last edited: 04/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Albert Wolkerstorfer
Scientific

Meibergdreef 35
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 6955
Email	a.wolkerstorfer@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, observer blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Centrale Commissie Mensgebonden Onderzoek (CCMO) on the 19th September 2007 (ref: NL18605.018.07).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Triple therapy bleaching cream (hydrochinon, tretinoin, triamcinolon acetonide)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	20
Key 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
Key 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)
Date of first enrolment	20/09/2007
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 35

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan