|- candidate number||6329|
|- NTR Number||NTR1957|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-aug-2009|
|- Secondary IDs||2009-015519-42 eudra-CT nummer|
|- Public Title||Laser treatment for Hidradenitis Suppuritiva.|
|- Scientific Title||The efficacy of Multiplex laser and methyl aminolevulinate for the treatment of Hidradenitis Suppurativa.|
|- hypothesis||The skin lesions of HS patients will significantly more improve after treatment with Multiplex laser combined with methyl aminolevulinate than after treatment with the only the multiplex laser.|
|- Healt Condition(s) or Problem(s) studied||Hidradenitis Suppuritiva|
|- Inclusion criteria||1. Male/female 18 years or older of age;|
2. Active moderate to moderate hidradenitis suppurativa (Hurley stage 1 or 2).
|- Exclusion criteria||1. Patients with a photoallergie or hypersensitivity to the active substance methyl aminolevulinate;|
2. Pregnant women.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-jun-2010|
|- Target number of participants||20|
|- Interventions||Multiplex laser (PDL 6-8 J/m2, 10 ms, 7 mm and the 1064 nm Nd-YAG 30-40 J/m2, 40-50 ms, 7 mm) combined with methyl aminolevulinate (1 mm cream on and 5-10 mm around the lesion) versus multiplexlaser (same fluence). |
|- Primary outcome||To determine the efficacy of Multiplex laser whether or not combined with Metvix in patients with mild to moderate HS.|
|- Secondary outcome||1. To determine the percentage improvement of the lesions, the degree of pain and the degree of treatment satisfaction;|
2. To determine the short-term side effects and tolerance of Multiplex laser whether or not combined with Metvix for the treatment of HS;
3. To determine the duration of remission during follow-up;
4. To dertermine changes of specific celpopulations.
|- Timepoints||1. Specific HS sartorius score: screening, week 2, 6, 10, 14, 18, 24;|
2. Skinbiopt: screening at week 18;
3. VAS (pain, gravity of disease and patient satisfaction), DQLI;
4. Skin fotographs: screening, week 2, 10, 18, 24.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. H.H. Zee, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. E. Prens|
|- Sponsor/Initiator ||Erasmus MC, Department of Immunology, Erasmus MC, Department of Dermatology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Dermatology, Erasmus Medical Center, Department of Immunology|
|- Brief summary||Observer-blinded intervention study.|
The skin lesions of 20 patients with mild to moderate HS wil be treated on one site of the body with multiplex laser combined with methyl aminolevulinate and on the other site of the body with multiplex laser.
|- Main changes (audit trail)|
|- RECORD||18-aug-2009 - 11-okt-2009|