Investigate the treatmentefficacy of a red light (633 nm) and blue light (425) combination PDT in HS.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction Sartorius score
reduction unidimensional visual painscore
Secondary outcome
Time to improvement individual laesions
Time to improvement painscale scores
Treatment experience
satisfaction
side effects
visual improvements on photo's
Background summary
Hidradenitis Suppurativa is a chronic inflammation of follicles, primarily in
the axillae and groin area. The disease manifests as clusters of chronic
abscesses or boils that are extremely painful to the touch and may persist for
years with occasional to frequent periods of inflammation.
Present treatment methods are: antibiotics, intralesional or systemic steroïds,
surigical operation and other methods like oral anticonceptives, ALA-PDT .
There are not many studies know that investigate PDT for HS. A combination
therapy is only known for acne vulgaris. The properties of red (633 nm) and
blue (425 nm) light complement each other in a way they can reduce the
inflammation, pain and might prevent new lesions.
Study objective
Investigate the treatmentefficacy of a red light (633 nm) and blue light (425)
combination PDT in HS.
Study design
single-blind prospective study.
Intervention
Every patient has at least one treatment- control combination with the same
Hurley classification. Every Hurley- combination consist of a treatment area
and a control are.
Treatment with: Omnilux Blue en Omnilux Revive.
Study burden and risks
Based on literature research and practical experience ewith the Omnilux Blue
and Revive for PDT treatment, no serious adverse events are to be expected.
-eye damage: wearing goggles
-erythema: Immediately after treatment. Lasts for about half an hour
-Irritation, itch, burning sensation: normally a few hours, in some cases a few
days
-Inflammation - In rare cases a temporarily eczema or folliculitis may appear.
This will last for a few weeks.
Michelangelolaan 2
5623 EJ eindhoven
Nederland
Michelangelolaan 2
5623 EJ eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Suffering from hidradenitis suppurativa. 18-45 years old. In case of oral medication/ anticonceptives: use of at least 6 months and intention te continue use during study.
Exclusion criteria
-Oral medication for HS in last 2 months
-In menopause or postmenopausal
-Intention to use anticonceptives
-Previous external or oral use of isotretinoine in last 6 months
-Oral/ local anti-inflammatory medication during the last 4 weeks
-Epilepsy
-Pregnancy, breastfeeding, intention to conceive
-Photosensitivity
-Use of photosensitive medication
-treatment for cancer in the past, history of skincancer, presence of premaligne lesions
-Use of anticoagulants, suffering from a clotting-disease.
-Surgical operations in the treatment areas in the past 6 months
-recently had PDT for HS
-Recent suntanning or planning to
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 |
|---|---|
| CCMO | NL19440.060.07 |