Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study

Not Applicable

Recruiting

• Conditions: Rosacea
• Interventions: Device: 532nm KTP; Device: 585nm PDL

• Registration Number: NCT05771298
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.

Detailed Description

Rosacea is a common, chronic inflammatory skin disease that usually affects the cheeks, nose, forehead, and chin \[1\]. Clinically, it presents initially with transient erythema (flushing) and telangiectasia. As it progresses, persistent erythema and papules and pustules appear. Phymatous changes result from hypertrophy of the sebaceous glands, and usually manifest as rhinophyma, gnatophyma, and metophyma \[2\]. Depending on the literature, rosacea has a prevalence of 1% to 22% \[3\]. Time of manifestation of the disease is usually between 30 and 50 years \[4\]. Women are more frequently affected \[4\].

For laser treatment of rosacea, the pulsed dye laser (PDL) with a wavelength of 595nm is frequently used. The treatment includes at least three sessions at intervals of about 4 weeks and leads to lightening and reduction of the lesions as well as reduction of papules and pustules. Various clinical studies have already demonstrated the high efficacy of PDL \[5-7\]. The treatment is painless, and local or general anesthesia is not necessary.

The KTP laser is also an option in the treatment of rosacea. Due to the more stable technology of the frequency-doubled Nd:YAG (KTP) and associated lower maintenance problems, this laser system appears to be a safer and more reliable treatment option for rosacea patients.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women 18 years and older
• Good general health, no relevant previous diseases
• Presence of rosacea
• Cognitive ability and willingness to give consent (Informed Consent)

Exclusion Criteria

• Age < 18 years
• Pregnant and breastfeeding women
• Significant open wounds or lesions of the region to be treated
• Metallic implants in the region to be treated
• Missing consent and/or data protection declarations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potassium Titanyle Phosphate (KTP) Laser	532nm KTP	Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks.
Pulsed Dye Laser	585nm PDL	Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks.

Primary Outcome Measures

Name	Time	Method
reduction of erythema	at follow-up visit 4 weeks after last treatment session	assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator
pain intensity	at follow-up visit 4 weeks after last treatment session	using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
swelling	at follow-up visit 4 weeks after last treatment session	assessment scale 1 - 6 (very - none) evaluated by subjects
purpura	at follow-up visit 4 weeks after last treatment session	assessment scale 1 - 6 (very - none) evaluated by subjects

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	at follow-up visit 4 weeks after last treatment session	assessment scale 1 - 6 (very - not at all) evaluated by subjects

Trial Locations

Locations (1)

Laser Department, University Medical-Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany