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The effect of ultraviolet radiation on the skin manifestations of patients with dermatomyositis.


- candidate number1312
- NTR NumberNTR181
- ISRCTNISRCTN35411849
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of ultraviolet radiation on the skin manifestations of patients with dermatomyositis.
- Scientific TitleThe effect of ultraviolet radiation on the skin manifestations of patients with dermatomyositis.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedDermatomyositis
- Inclusion criteria1. Patients with 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.
- Exclusion criteriaAny malignancy for which the patient is treated with cytostatic drugs and/or radiotherapy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-sep-2004
- planned closingdate24-sep-2006
- Target number of participants10
- InterventionsIn summary, we will use our phototest protocol for patients with DM;
1. To determine the minimal erythema dose (MED) for UVB, UVA, and visible light.
2. To determine the clinical aspect of the photoprovoked skin lesions.
3. To determine the time interval between the start of phototesting 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. B. Determination of the cellular trafficking in the initial cutaneous inflammation induced by photoprovocation 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.
- Primary outcomeIn summary, we will 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 outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Cornelus J.G. Sanders
- CONTACT for SCIENTIFIC QUERIESMD. Cornelus J.G. Sanders
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Dermatology and Allergology
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryIn summary, we will 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.
- Main changes (audit trail)
- RECORD29-aug-2005 - 27-okt-2010


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