Rosacea
Conditions
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.
Interventions
one to three treatment sessions
one to three treatment sessions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity | at follow-up visit 4 weeks after last treatment session | using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | at follow-up visit 4 weeks after last treatment session | assessment scale 1 - 6 (very - not at all) evaluated by subjects |
Countries
Germany