No registrations found.
ID
Source
Brief title
Health condition
Hidradenitis Suppuritiva
Sponsors and support
Burg. s’ Jacobplein 51,
3015 CA Rotterdam,
The Netherlands
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
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.
Intervention
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).
Dr. Molewaterplein 50
H.H. Zee, van der
Dr. Molewaterplein 50
Rotterdam 3015 GE
The Netherlands
+31107043430
h.vanderzee@erasmusmc.nl
Dr. Molewaterplein 50
H.H. Zee, van der
Dr. Molewaterplein 50
Rotterdam 3015 GE
The Netherlands
+31107043430
h.vanderzee@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1846 |
| NTR-old | NTR1957 |
| Other | eudra-CT nummer : 2009-015519-42 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |