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

Completed

Conditions: Melasma
Skin and Connective Tissue Diseases
Disorders of pigmentation

Registration Number: ISRCTN84133969

Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Objective colour measurement by reflectance spectroscopy, measured before treatment and during 3, 12 and 24 weeks of follow-up

Secondary Outcome Measures

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