Contact information
Type
Scientific
Primary contact
Dr Cornelus J.G. Sanders
ORCID ID
Contact details
University Medical Centre
Department of Dermatology/Allergology
G02.124
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
c.sanders@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR181
Study information
Scientific title
Acronym
Study hypothesis
To determine the initial cutaneous response after ultraviolet B (UVB) provocation of the skin. Specifically we will determine the trafficking of Langerhans cell, leucocytes and lymphocytes and the expression of matrix metalloproteinases (MMP) in skin lesions and compare these with healthy controls, patients with lupus erythematosus and patients with polymorphic light eruption, for which the results have already been obtained.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, single blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Dermatomyositis
Intervention
Phototest protocol for patients with DM:
1. To determine the minimal erythema dose (MED) for UVB, ultraviolet A (UVA), and visible light
2. To determine the clinical aspect of the photo provoked skin lesions
3. To determine the time interval between the start of photo testing and induction of skin lesions until their resolution
4. To record any adverse events
The information thus acquired can be used to advice the patient more specifically on appropriate protection measures that can be taken against environmental UV radiation. Determination of the cellular trafficking in the initial cutaneous inflammation induced by photo provocation in patients with DM. After determination of the MED for UVB a test area of 5 cm square on the upper back will be exposed to 3 MED UVB. Skin biopsies (4 mm) will be taken of the test area at 0, 24, 48 and 72 hours after one single UVB exposure with 3 MED. These skin biopsies will be compared with those of healthy controls, patients with lupus erythematosus and patients with polymorphic light eruption. The results for these groups have already been obtained.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Determine the initial cutaneous response after UVB provocation of the skin. Specifically we will determine the trafficking of Langerhans cell, leucocytes and lymphocytes and the expression of MMP in skin lesions and compare these with healthy controls, patients with lupus erythematosus and patients with polymorphic light eruption, for which the results have already been obtained.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/09/2004
Overall trial end date
24/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with dermatomyositis (DM) that have been diagnosed according to international accepted guidelines (1 - 3)
2. The medication that is used by the patients specifically for DM or other related symptoms will be continued during phototesting
3. The patients should not use corticosteroid creams or sunscreens during phototesting
4. Patients with DM are invited to participate in this study and are included after signed informed consent is obtained
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
Any malignancy for which the patient is treated with cytostatic drugs and/or radiotherapy.
Recruitment start date
24/09/2004
Recruitment end date
24/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre
Utrecht
3584 CX
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary