Condition category
Skin and Connective Tissue Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

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

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

Publication citations

Additional files

Editorial Notes