Fractional photothermolysis versus triple therapy for the treatment of melasma: a randomised controlled trial
| ISRCTN | ISRCTN84133969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84133969 |
| Secondary identifying numbers | fraxel-1 |
- 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
Scientific
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 6955 |
|---|---|
| a.wolkerstorfer@amc.uva.nl |
Study information
| Study design | Randomised, controlled, parallel group, observer blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Triple therapy bleaching cream (hydrochinon, tretinoin, triamcinolon acetonide) |
| Primary outcome measure | 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 study start date | 20/09/2007 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 6955 |
|---|---|
| a.wolkerstorfer@amc.uva.nl | |
| Website | http://www.amc.uva.nl |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
