Rosacea and the subpurpuric pulsed dye laser treatment efficacy - a randomized controlled trial

Rosacea and the subpurpuric pulsed dye laser treatment efficacy - a randomized controlled trial - RoSE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41694

Enrollment

Registered

2012-12-06

Start date

2013-03-27

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rosacea (subtype 1/erythematotelangiectatic): facial telangiectasia

Interventions

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).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subject has erythematotelangiectatic rosacea with at least 5 telangiectasia. Skintype I-III according to Fitzpatrick.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
• 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

Measure	Time frame
• Patient*s Global Assessment (PGA) • Blinded evaluation of photographs: Clinician's Erythema Assessment (CEA) and grading the severity of telangiectasia	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)