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To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium Titanyle Phosphate (KTP) Laser | Other | Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks. |
|
| Pulsed Dye Laser | Other | Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532nm KTP | Device | one to three treatment sessions |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L Nguyen, MD | Contact | +49 (0)40 7410-0 | l.nguyen@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| L Nguyen, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Department, University Medical-Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25919144 | Background | van Zuuren EJ, Fedorowicz Z, Carter B, van der Linden MM, Charland L. Interventions for rosacea. Cochrane Database Syst Rev. 2015 Apr 28;2015(4):CD003262. doi: 10.1002/14651858.CD003262.pub5. | |
| 29091565 | Background | van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available. |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 585nm PDL |
| Device |
one to three treatment sessions |
|
| 24229634 | Background | Tan J, Berg M. Rosacea: current state of epidemiology. J Am Acad Dermatol. 2013 Dec;69(6 Suppl 1):S27-35. doi: 10.1016/j.jaad.2013.04.043. |
| 20586834 | Background | Elewski BE, Draelos Z, Dreno B, Jansen T, Layton A, Picardo M. Rosacea - global diversity and optimized outcome: proposed international consensus from the Rosacea International Expert Group. J Eur Acad Dermatol Venereol. 2011 Feb;25(2):188-200. doi: 10.1111/j.1468-3083.2010.03751.x. Epub 2010 Jun 25. |
| 30285506 | Background | Kim BY, Moon HR, Ryu HJ. Comparative efficacy of short-pulsed intense pulsed light and pulsed dye laser to treat rosacea. J Cosmet Laser Ther. 2019 Aug;21(5):291-296. doi: 10.1080/14764172.2018.1528371. Epub 2018 Oct 4. |
| 32141785 | Background | Osman M, Shokeir HA, Hassan AM, Atef Khalifa M. Pulsed dye laser alone versus its combination with topical ivermectin 1% in treatment of Rosacea: a randomized comparative study. J Dermatolog Treat. 2022 Feb;33(1):184-190. doi: 10.1080/09546634.2020.1737636. Epub 2020 Mar 12. |
| 29635699 | Background | Bernstein EF, Schomacker K, Paranjape A, Jones CJ. Pulsed dye laser treatment of rosacea using a novel 15 mm diameter treatment beam. Lasers Surg Med. 2018 Oct;50(8):808-812. doi: 10.1002/lsm.22819. Epub 2018 Apr 10. |
| 38794945 | Derived | Nguyen L, Seeber N, Kautz G, Hartjen A, Schneider SW, Herberger K. 532-nm potassium titanyl-phosphate laser versus 595-nm pulsed dye laser for port-wine birthmarks: A prospective, randomized, split-side study. J Eur Acad Dermatol Venereol. 2024 Jun;38(6):1140-1146. doi: 10.1111/jdv.19750. Epub 2023 Dec 21. |