|- candidate number||19532|
|- NTR Number||NTR4804|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2014|
|- Secondary IDs||NL40799.018.12 |
|- Public Title||Rosacea and the Subpurpuric pulsed dye laser treatment Efficacy
|- Scientific Title||Rosacea and the Subpurpuric pulsed dye laser treatment Efficacy
|- hypothesis||We hypothesize that the experimental 2-week interval will neither cause a difference in burden nor in risks. It probably will lead to better results and it has the advantage that the total duration of treatment is shorter.|
|- Healt Condition(s) or Problem(s) studied||Rosacea, Laser treatment|
|- Inclusion criteria||1. Subject has rosacea subtype 1 (erythematotelangiectatic) with at least 5 telangiectasia. |
2. Subject is at least 18 years of age at baseline.
3. Subject has skin type I or II according to Fitzpatrick.
4. Subject can fill out a Dutch questionnaire or has a person willing to translate the questions in their own language.
5. Subject has voluntarily signed and dated an informed consent prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
|- Exclusion criteria||1. Subject has steroid or other medication induced rosacea|
2. Subject takes medicines that are known to trigger rosacea.
3. Subject has used systemic rosacea medication in the past 3 months.
4. Subject is pregnant.
5. Presence of dermatoses that might interfere with the rosacea or the evaluation of treatment results.
6. Subject has had facial laser-therapy less than 12 months before baseline or receives laser therapy beyond the study protocol during study.
7. Subject has used isotretinoin six months prior to the first treatment.
8. Subject is known to have a seizure disorder triggered by light.
9. Subject has atypical melanocytic lesion(s) on the face.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2013|
|- planned closingdate||1-jul-2016|
|- Target number of participants||58|
|- Interventions||Subjects receive subpurpuric Pulsed Dye Laser (PDL) treatments until their visible telangiectasia are disappeared with a maximum of 4 treatments, separated by either a 2-week interval (Arm 1) or an 8-week interval (Arm 2).
|- Primary outcome||• Health Related Quality of Life (HRQoL) measurement as a patient reported outcome (PRO) by using the RosaQol, a rosacea-specific HRQoL questionnaire|
• Blinded evaluation of photographs by using the Investigators Global Assessment (IGA)
|- Secondary outcome||• Blinded evaluation of photographs by |
- using Clinician's Erythema Assessment (CEA)
- grading of severity of telangiectasia
Patient’s Global Assessment (PGA)
|- Timepoints||Patients will be seen at screening and at 2 weeks or 8-weeks interval between the treatments, with a maximum of 4 treatments. Follow up 8-10 weeks ana 1 year after last treatment.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.M.D. Linden, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Phyllis I. Spuls|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Dermatology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Dermatology|
|- Brief summary||PDL therapy is used worldwide for erythematotelangiectatic rosacea. Subpurpuric PDL treatment is characterized by using a fluence that is just below the purpura threshold of the patient. With these settings posttreatment side effects such as purpura can be avoided. Lasers and accompanying settings improved a lot since introduction, but optimal therapy parameters and intervals between treatments have not yet been decided. |
|- Main changes (audit trail)|
|- RECORD||23-sep-2014 - 15-okt-2014|