The effect of ultraviolet radiation on the skin manifestations of patients with dermatomyositis
ISRCTN | ISRCTN35411849 |
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DOI | https://doi.org/10.1186/ISRCTN35411849 |
Secondary identifying numbers | NTR181 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cornelus J.G. Sanders
Scientific
Scientific
University Medical Centre
Department of Dermatology/Allergology, G02.124
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
c.sanders@azu.nl |
Study information
Study design | Randomised, single blind, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 24/09/2004 |
Completion date | 24/09/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 10 |
Key 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 |
Key exclusion criteria | Any malignancy for which the patient is treated with cytostatic drugs and/or radiotherapy. |
Date of first enrolment | 24/09/2004 |
Date of final enrolment | 24/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
Website | http://www.umcutrecht.nl/zorg/ |
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https://ror.org/04pp8hn57 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |