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02 September 2010
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| [ Print-friendly version ] |
| Fractional photothermolysis versus triple therapy for the treatment of melasma: a randomised controlled trial |
| ISRCTN | ISRCTN84133969 |
| ClinicalTrials.gov identifier | |
| Public title | Fractional photothermolysis versus triple therapy for the treatment of melasma: a randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | fraxel-1 |
| 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 |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Melasma |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 20/09/2007 |
| Anticipated end date | 01/05/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 20 |
| Interventions |
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. |
| 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 |
| 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 |
| Sources of funding | Academic Medical Centre (AMC) (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr Albert Wolkerstorfer |
| Address | Meibergdreef 35 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 566 6955 |
| Fax | +31 (0)20 566 6955 |
| a.wolkerstorfer@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Address | Meibergdreef 35 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 566 6955 |
| Fax | +31 (0)20 566 9079 |
| a.wolkerstorfer@amc.uva.nl | |
| Sponsor website: | http://www.amc.uva.nl |
| Date applied | 13/07/2007 |
| Last edited | 04/03/2008 |
| Date ISRCTN assigned | 04/03/2008 |
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