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

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

Detailed Description
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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.

Official Title
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Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study

Conditions
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Rosacea

Intervention / Treatment
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* Device: 532nm KTP
* Device: 585nm PDL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Potassium Titanyle Phosphate (KTP) Laser<br>Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks. | Device: 532nm KTP<br>* one to three treatment sessions<br>|
| Other: Pulsed Dye Laser<br>Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks. | Device: 585nm PDL<br>* one to three treatment sessions<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | assessment scale 1 - 6 (very - not at all) evaluated by subjects | at follow-up visit 4 weeks after last treatment session |