Primary objectiveTo compare the efficacy of subpurpuric pulsed dye laser treatment with different intervals between treatment sessions.Secondary objectiveTo evaluate the safety and the long-term effects of subpurpuric pulsed dye laser treatment.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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: Investigators Global Assessment (IGA)
Secondary outcome
• Patient*s Global Assessment (PGA)
• Blinded evaluation of photographs: Clinician's Erythema Assessment (CEA) and
grading the severity of telangiectasia
Background summary
Rosacea is a common chronic disease which can not be cured. Fortunately,
symptomatic treatments are available. The pulsed dye laser has been a widely
used standard treatment for years, especially for erythematotelangiectatic
rosacea, because of its good results and safety profile. The laser and the
accompanying settings improved a lot since introduction, but they*re still not
optimal. More evidence is necessary.
Study objective
Primary objective
To compare the efficacy of subpurpuric pulsed dye laser treatment with
different intervals between treatment sessions.
Secondary objective
To evaluate the safety and the long-term effects of subpurpuric pulsed dye
laser treatment.
Study design
A randomized controlled, mono-centre, two-arm, single-blinded, open-label
trial, during 72-92 weeks, consisting of 20-40 weeks of treatment and a
12-month follow-up period.
Intervention
Subjects receive 3 or 4 subpurpuric pulsed dye laser treatment sessions
separated by either a 2-week interval (Arm 1) or an 8-week interval (Arm 2).
Study burden and risks
The treatment subjects receive is already a standard treatment.
Only the 2-week interval differs from the standard treatment, but we neither
expect this experimental interval to cause a difference in burden nor in risks.
It probably will lead to better or the same results and it has the potential to
reduce the total duration of a course of treatment.
Subjects have to fill in short questionnaires and a patient*s diary and they*ll
have an extra control visit, unlike other outpatients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Subject has erythematotelangiectatic rosacea with at least 5 telangiectasia.
Skintype I-III according to Fitzpatrick.
Exclusion criteria
Subject is pregnant.
Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results.
Subject has used isotretinoin six months prior to the first treatment session.
Subject is known to have a seizure disorder triggered by light.
Subject has suspicious pigmented lesions on the face.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL40799.018.12 |
| OMON | NL-OMON20185 |