Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study
Study Details
Study Description
Brief Summary
To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Potassium Titanyle Phosphate (KTP) Laser Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks. |
Device: 532nm KTP
one to three treatment sessions
|
| Other: Pulsed Dye Laser Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks. |
Device: 585nm PDL
one to three treatment sessions
|
Outcome Measures
Primary Outcome Measures
- 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
- patient satisfaction [at follow-up visit 4 weeks after last treatment session]
assessment scale 1 - 6 (very - not at all) evaluated by subjects
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laser Department, University Medical-Center Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: L Nguyen, MD, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
- 01-22