search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Laser treatment for Hidradenitis Suppuritiva.


- candidate number6329
- NTR NumberNTR1957
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2009
- Secondary IDs2009-015519-42 eudra-CT nummer
- Public TitleLaser treatment for Hidradenitis Suppuritiva.
- Scientific TitleThe efficacy of Multiplex laser and methyl aminolevulinate for the treatment of Hidradenitis Suppurativa.
- ACRONYMN/A
- hypothesisThe 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) studiedHidradenitis Suppuritiva
- Inclusion criteria1. Male/female 18 years or older of age;
2. Active moderate to moderate hidradenitis suppurativa (Hurley stage 1 or 2).
- Exclusion criteria1. Patients with a photoallergie or hypersensitivity to the active substance methyl aminolevulinate;
2. Pregnant women.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-jun-2010
- Target number of participants20
- InterventionsMultiplex 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 outcomeTo determine the efficacy of Multiplex laser whether or not combined with Metvix in patients with mild to moderate HS.
- Secondary outcome1. 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.
- Timepoints1. 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.H. Zee, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. E. Prens
- Sponsor/Initiator Erasmus MC, Department of Immunology, Erasmus MC, Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Dermatology, Erasmus Medical Center, Department of Immunology
- PublicationsN/A
- Brief summaryObserver-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)
- RECORD18-aug-2009 - 11-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl