RosaceaNCT05771298
Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study
A study testing 532nm KTP and 585nm PDL in people with Rosacea, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- 532nm KTP and 585nm PDL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Laser Department, University Medical-Center Hamburg-Eppendorf
Hamburg, 20246
L Nguyen, MD, 040 7410 0
About this study
Official title: Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study
To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.
Read the 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.
- Conditions
- Rosacea
- Being tested
- 532nm KTP, 585nm PDL
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532nm KTPDevice
one to three treatment sessions
585nm PDLDevice
one to three treatment sessions
| Study group | Role | What they receive |
|---|---|---|
| Potassium Titanyle Phosphate (KTP) Laser | Other | Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks. Receives: Device: 532nm KTP |
| Pulsed Dye Laser | Other | Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks. Receives: Device: 585nm PDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of erythema
assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator
Measured: at follow-up visit 4 weeks after last treatment session
pain intensity
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
Measured: at follow-up visit 4 weeks after last treatment session
swelling
assessment scale 1 - 6 (very - none) evaluated by subjects
Measured: at follow-up visit 4 weeks after last treatment session
purpura
assessment scale 1 - 6 (very - none) evaluated by subjects
Measured: at follow-up visit 4 weeks after last treatment session
Secondary outcomes (1)
patient satisfaction
assessment scale 1 - 6 (very - not at all) evaluated by subjects
Measured: at follow-up visit 4 weeks after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Feb 2023
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L Nguyen, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771298
- Sponsor's protocol ID
- 01-22
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25919144van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
PubMed 29091565Tan 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.
PubMed 24229634Elewski 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.
PubMed 20586834Kim 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.
PubMed 30285506Osman 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.
PubMed 32141785Bernstein 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.
PubMed 29635699Nguyen 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.
PubMed 38794945
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT05771298
- Acronym / sponsor ID
- 01-22
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Titanyle Phosphate (KTP) Laser | Other | Device: 532nm KTPSubjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks. |
| Pulsed Dye Laser | Other | Device: 585nm PDLSubjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 532nm KTPone to three treatment sessions | Device | Potassium Titanyle Phosphate (KTP) Laser |
| 585nm PDLone to three treatment sessions | Device | Pulsed Dye Laser |
Primary outcome
reduction of erythema
Time frame: 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
Time frame: at follow-up visit 4 weeks after last treatment session
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
swelling
Time frame: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
purpura
Time frame: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
1 secondary outcome
patient satisfaction
Time frame: at follow-up visit 4 weeks after last treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 25919144van 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.
- Background: PubMed 29091565van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
- Background: PubMed 24229634Tan 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.
- Background: PubMed 20586834Elewski 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.
- Background: PubMed 30285506Kim 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.
- Background: PubMed 32141785Osman 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.
- Background: PubMed 29635699Bernstein 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.
- Derived from this study: PubMed 38794945Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L Nguyen, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 532nm KTP and 585nm PDL in people with Rosacea, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L Nguyen, MD (+49 (0)40 7410-0, l.nguyen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of erythema (time frame: at follow-up visit 4 weeks after last treatment session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771298, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.