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 design	Randomised, single blind, active controlled, parallel group trial
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
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

Sponsor information

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

PO Box 85500
Utrecht
3508 GA
Netherlands

Website	http://www.umcutrecht.nl/zorg/
"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 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