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

ISRCTN ISRCTN35411849
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

University Medical Centre
Department of Dermatology/Allergology, G02.124
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Email c.sanders@azu.nl

Study information

Study designRandomised, single blind, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedDermatomyositis
InterventionPhototest 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 typeOther
Primary outcome measureDetermine 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 measuresNot provided at time of registration
Overall study start date24/09/2004
Completion date24/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants10
Key inclusion criteria1. 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 criteriaAny malignancy for which the patient is treated with cytostatic drugs and/or radiotherapy.
Date of first enrolment24/09/2004
Date of final enrolment24/09/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre
Utrecht
3584 CX
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (Netherlands)
University/education

PO Box 85500
Utrecht
3508 GA
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan