Melasma Skin and Connective Tissue Diseases Disorders of pigmentation
Conditions
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 f
Sponsors
Academic Medical Centre (AMC) (The Netherlands)
Eligibility
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed